Sample Quality Manual

Quality Manual QM0492 Rev.
BF
Logistics & EM Americas
AVNET Logistics
&
EM Americas
Quality Manual
Avnet is committed to ensuring customer satisfaction while meeting all customer and applicable legal,
statutory and regulatory requirements. This is accomplished by ensuring that the Quality Management
System (QMS)and Environmental Management System (EMS), as applicable is implemented, effective
and continually improving to meet the ever changing needs of our customers, community, and Avnet.
Top Management is committed to lead the organization using the eight (8) Quality Management
Principles:
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision-making
8. Mutually beneficial supplier relationships
This Quality System Manual defines the policies and procedures used to ensure that products and
services meet the customer requirements.
Maintenance of this manual is the responsibility of the V.P. Global Quality, Andy De La Torre. All
questions regarding this manual should be directed to him.
Printed documents are uncontrolled copies – access the Intranet Quality System to verify the latest revision of this document
Avnet, Inc. Page 1 of 33
Business Use Only
Quality Manual QM0492 Rev. BF
Table of Content
ISO 9001:2008 ISO 14001:2004
Page Paragraph Subject Title Clause # Clause #
1  Cover Page  
2-3  Table of Content  
4 1.0 Purpose 4.2.1; 4.2.2 4.4.4
4 2.0 Scope 4.2.1; 4.2.2 4.1; 4.4.4
4-5 3.0 Exclusions and Not Applicable Clauses 4.2.2 
5 4.0 Relevant Documents  
5-6 5.0 Management Responsibility 4.2.1; 5.0; 5.1; 4.2; 4.3.3; 4.4.3;
5.2; 5.3; 5.4.1; 4.4.4; 4.6
5.5.3; 8.5.1
6 6.0 Organization 5.5; 5.5.1 4.4.1
7 7.0 Management Representative 5.5.2 4.4.1
7 8.0 Management Review 5.6; 5.6.1; 4.6
5.6.2; 5.6.3;
8.5.1
7 9.0 Customer Satisfaction 8.2.1; 8.5.1 
8 10.0 Resources 6.0; 6.1; 6.3; 4.4.1
8.5.1
8 11.0 Training 6.2.1; 6.2.2 4.4.2
8 12.0 Planning 5.4.2; 7.1 4.3; 4.3.1;
4.3.2; 4.3.3
9 13.0 Customer Requirements 5.2; 7.2; 7.2.1; 
7.2.2; 7.2.3
9 14.0 Documentation 4.0; 4.1; 4.2.1; 4.1; 4.4.4; 4.4.5
4.2.2
9-10 15.0 Document Control 4.2.1; 4.2.3 4.4.4; 4.4.5
10 16.0 Control of Records 4.2.1; 4.2.4 4.5.4
10-11 17.0 Purchasing 7.4; 7.4.1; 
7.4.2; 7.4.3
11 18.0 Control of Customer Supplied Product 7.5.4 
11 19.0 Product Identification and Traceability 7.5.3 
11-12 20.0 Process Control 4.1; 6.3; 6.4; 4.4.6
7.5; 7.5.1
12 21.0 Inspection and Testing 7.4.3; 8.2.3; 
8.2.4; 8.3
12-13 22.0 Control of Monitoring and Measuring 7.5.1; 7.6 4.5.1
Equipment
13 23.0 Control of Nonconforming Product 8.3 4.5.3
13 24.0 Corrective Action and Preventive Action 8.5.2; 8.5.3 4.5.3
14 25.0 Handling, Storage, Preservation, Packaging, 7.5.1; 7.5.5 
and Delivery
14 26.0 Internal Audits 8.2.2 4.5.5
14 27.0 Statistical Techniques 8.0; 8.1; 8.4 4.5.1
14 28.0 Continual Improvement 8.5; 8.5.1 4.1; 4.3.3
14 29.0 Design and Development (Not Applicable) 7.3 
14-15 30.0 Emergency Preparedness and Response (EMS)  4.4.7
15 31.0 Evaluation of Compliance (EMS)  4.5.2
15 32.0 Communications (EMS)  4.4.3
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Table of Content (Continued)

AS9100
Page Paragraph Subject Title Clause #
15-20 33.0 Supplemental Requirements for AS9100 4.2.1; 4.2.4; 5.2; 5.5.2; 7.1; 7.1.1;
Registered Facilities 7.1.2; 7.1.3; 7.1.4; 7.2.2; 7.4.1;
7.4.2; 7.4.3; 7.5.1; 7.5.1.1;
7.5.1.2; 7.5.1.3; 7.5.1.4; 7.5.3;
7.5.5; 7.6; 8.2.1; 8.2.3; 8.2.4; 8.3;
8.5.1; 8.5.2
ISO 13485
20-25 34.0 Supplemental Requirements for ISO 13485 4.2.1; 4.2.3; 4.2.4; 5.5.1; 5.5.2;
Registered Facilities 5.6.2; 5.6.3; 6.1; 6.3; 6.4; 7.1;
7.2.2; 7.2.3; 7.4.1; 7.4.2; 7.4.3;
7.5.1.1; 7.5.1.2; 7.5.1.2.1;
7.5.1.2.2; 7.5.1.2.3; 7.5.1.3;
7.5.2.1; 7.5.2.2; 7.5.3.1; 7.5.3.2;
7.5.3.2.1; 7.5.3.2.2; 7.5.3.3; 7.5.5;
7.6; 8.1; 8.2.1; 8.2.4.2; 8.3; 8.4;
8.5.1; 8.5.2; 8.5.3
TS16949
25-33 35.0 Supplemental Requirements for TS16949 4.1.1; 4.2.3.1; 4.2.4.1; 5.1.1;
Registered Facilities 5.4.1.1; 5.5.1.1; 5.5.2.1; 5.6.1.1;
5.6.2.1; 6.2.2.2; 6.2.2.3; 6.2.2.4;
6.3.1; 6.3.2; 6.4.1; 6.4.2; 7.1.1;
7.1.2; 7.1.3; 7.1.4; 7.2.1.1;
7.2.2.1; 7.2.2.2; 7.2.3.1; 7.3;
7.3.1.1; 7.3.2.2; 7.3.2.3; 7.3.3.2;
7.3.4.1; 7.3.5; 7.3.6.1; 7.3.6.2;
7.3.6.3; 7.4.1.1; 7.4.1.2; 7.4.1.3;
7.4.3.1; 7.4.3.2; 7.5.1.1; 7.5.1.2;
7.5.1.3; 7.5.1.4; 7.5.1.5; 7.5.1.6;
7.5.1.7; 7.5.1.8; 7.5.2.1; 7.5.3.1;
7.5.4.1; 7.5.5.1; 7.6.1; 7.6.2;
7.6.3.1; 7.6.3.2; 8.1.1; 8.1.2;
8.2.1.1; 8.2.2.1; 8.2.2.2; 8.2.2.3;
8.2.2.4; 8.2.2.5; 8.2.3.1; 8.2.4.1;
8.2.4.2; 8.3.1; 8.3.2; 8.3.3; 8.3.4;
8.4.1; 8.5.1.1; 8.5.1.2; 8.5.2.1;
8.5.2.2; 8.5.2.3; 8.5.2.4;
Appendices
Appendix I Registered Facilities
Appendix II Organization Chart
Appendix III Processes - ISO 9001 & ISO 14001
Appendix IV QMS/EMS Procedures
Appendix V Programming QMS Processes - TS16949
Appendix VI AS9100 Cross Reference Document
Appendix VII Logistics QMS Processes - AS9100
Appendix VIII Value-Add Assembly QMS Processes - AS9100
Appendix IX Programming QMS Processes - AS9100
Appendix X Elements of EMS Interaction
Appendix XI ATS Business Process Documents
Business Use Only
1.0 Purpose
1.1 This manual defines the policies and procedures used at Avnet to document the:
Quality Policies (QMS and EMS),
Quality Objectives,
Requirements of ISO 9001 and ISO 14001,
Supplemental requirements of AS9100, ISO 13485, and TS16949,
Requirements for effective planning, operation and control of processes, and
Records maintained.
1.2 Supplemental requirements for facilities registered to AS9100 are in section 33.0 of this
manual.
1.3 Supplemental requirements for facilities registered to ISO 13485 are in section 34.0 of this
manual.
1.4 Supplemental requirements for facilities maintaining compliance to TS16949 are in section
35.0 of this manual.
2.0 Scope
2.1 This manual defines the QMS and EMS requirements, as applicable used at each Logistics
Americas facility defined in Appendix I.
2.1.1 Appendix I reference to ISO 9001 registered facilities, activities and clauses not
applicable at each location are listed on page 1.
2.1.2 Appendix I reference to AS9100 registered facilities, activities and clauses not
applicable at each location are listed on page 2.
2.1.3 Appendix I reference to ISO14001 registered facilities, and the scope of each
facility is listed on page 2.
2.1.4 Appendix I reference to ISO13485 registered facilities and the scope of each
facility is listed on page 2.
3.0 Exclusions and Not Applicable Clauses
3.1 ISO 9001
3.1.1 Clause 7.3 Design and Development, is not performed within Avnet Logistics and
Avnet EM Americas, since all locations distribute, program and/or assemble
electronic components/computer products/cables/connectors for franchised
suppliers and/or to customer requirements. Product Design and Development is
the responsibility of the customer.
3.1.2 Clause 7.5.2, Production and Service Operations, is not applicable. No
processes exist that cannot be verified by subsequent measurement or
monitoring. Clause 7.5.2 is addressed by Supplement III for ISO 13485.
3.2 AS9100
3.2.1 Clause 7.3, Design and Development, is not performed within Avnet EM
Americas and Avnet Logistics, since all locations distribute, program and/or
assemble electronic components/computer products/cables/connectors for
franchised suppliers and/or to customer requirements. Product Design and
Development is the responsibility of the customer.
3.2.2 Clause 7.5.1.1 of AS9100, Production Process Verification is not applicable for
Connector Assembly. Avnet is the QPL assembler for Connector Manufacturers
and assemble the connectors for customer orders to manufacturer’s instructions.
3.2.3 Clause 7.5.1.4 of AS9100, Post Delivery Support is not applicable in facilities
registered to AS9100. Servicing is not applicable to Avnet’s distribution,
assembly, or value-add business.
Business Use Only
3.3 ISO 13485

3.3.1 Clause 7.3 of ISO13485, Product Design is the responsibility of the customer in
ISO13485 registered facilities.
3.3.2 Clauses of ISO13485 which are not applicable to Avnet’s product or business
are:
a) Clause 7.5.1.2 Control of production and service provision
b) Clause 7.5.1.2.1 Cleanliness of product and contamination control
c) Clause 7.5.1.2.2 Installation activities
d) Clause 7.5.1.2.3 Servicing activities
e) Clause 7.5.1.3 Particular requirements for sterile medical devices
f) Clause 7.5.2.2 Particular requirements for sterile medical devices
g) Clause 7.5.3.2.2 Particular requirements for active implantable medical
devices and implantable medical devices
h) Clause 8.2.4.2 Monitoring and measurement of product for active
implantable
3.4 Clauses that are not applicable to a specific location are specified on the ISO Registered
Facilities List, Appendix I.
4.0 Relevant Documents
4.1 ISO 9001:2008 Quality Management Systems Requirements
4.2 ISO/TS16949:2009 Quality Management Systems – Particular Requirements for the
application of ISO 9001:2008 for automotive production and
relevant service part organizations
4.3 AS9100C Quality Management Systems – Requirements for Aviation,
Space and Defense Organizations
4.4 ISO 14001:2004 Environmental Management Systems – Requirements with

Guidance for Use
4.5 ISO 13485:2003 Medical Devices – Quality management systems - Requirements

For regulatory purposes
5.0 Management Responsibility

5.1 Top management for each division has established the Quality and Environmental Policies,
as applicable and Quality Objectives. Top management ensures that the Quality and
Environmental Policies are appropriate to the purpose of the organization, that they include
their commitment to comply with requirements and continually improve the effectiveness of
the QMS and EMS, are communicated and understood within all levels of the Organization,
are reviewed for continuing suitability and that they provide the framework for establishing
and reviewing Quality Objectives and Environmental Objectives and Targets.
5.2 Top management has defined the Quality and Environmental Policies. The Environmental
Policy will be made available to the public upon request.
Quality Policy
Each Avnet employee will provide defect-free services and products that fully meet established
requirements to our internal and external customers, and is committed to continually improve the
effectiveness of the Quality Management System. We will achieve this through the process of
defining and understanding, as well as agreeing and conforming, to customer requirements.
Business Use Only
Environmental Policy
Avnet is committed to practicing environmentally responsible business processes. Our goal is
continual improvement, prevention of pollution, and compliance with applicable legal and other
requirements relating to our environmental aspects.
5.3 Top management communicates to the organization its commitment to the QMS and EMS
through system news, newsletters, broadcasts, etc.
5.4 Management in all areas communicates to their organization at all levels the effectiveness of
the QMS and the importance of meeting customer as well as legal, statutory and regulatory
requirements.
5.5 Top management has defined measurable objectives for quality for the applicable division,
which are derived from the objectives set by Executive Management. These objectives
include product requirements, are consistent with the Quality Policy, and are measurable.
Quality objectives are measurable and the achievement of the objectives is included in
management review. The Quality Objectives are located on the Quality Assurance Intranet
site.
5.5.1 Environmental objectives and targets are facility specific. Management at each
location registered to ISO14001 has established and documented the locations’
environmental objectives and targets, assigned responsibility for achieving
objectives and targets and methods, resources and time-frame by which they are
to be achieved. The objectives and targets are measurable, where practicable,
and the achievement of the objectives and targets is included in management
review.
6.0 Organization
6.1 The organization is comprised of:
Marketing/Sales
Human Resources
Purchasing
Logistics
Value Add (Programming, Integration, Connector & Cable Assembly)
Quality Assurance
Information Services
6.2 Organization charts that show the relationship of the organizations to the corporate
management structure and the relationship of the various functions to each other are
maintained on the Avnet Intranet. The corporate organization is shown in Appendix II and is
comprised of the Product Business Groups and Sales for the three major product types
represented by EM Americas, Broadline and Memec (Integrated Circuits and
Semiconductors), and IP&E Interconnect, Passive and Electro Mechanical). Also,
represented is ATS Americas, which is comprised of Sales & Marketing, Purchasing,
Materials, and Support Operations. Located within the Logistic Center Group are the
warehouses, value add assembly, programming centers and integration that support EM
Americas and ATS Americas.
6.3 Employees within the organization have a clear understanding of their roles and
responsibilities within the company through training and as defined in specific work
instructions.
6.4 Job descriptions define each employee's general job requirements and are posted on the
Avnet Intranet or maintained within job description manuals at each location. Annual goal
setting to define specific tasks and responsibilities for the current year are given to each
employee.
Business Use Only
7.0 Management Representative

7.1 The V.P. Global Quality, Andy De La Torre has appointed a Management Representative,
Kelley Brown, Director Quality Engineering, to ensure that the QMS and EMS are
established, implemented, and maintained. The Management Representative is responsible
for reporting to Top Management on the overall performance of the QMS and EMS and the
need for improvement on an annual basis.
7.2 Quality Representatives have been assigned for each registered location specified in
Appendix I, for reviewing and reporting the performance of the QMS and EMS (as
applicable) for that location and the need for improvement within that location as a minimum
on an annual basis. Some locations may perform on a quarterly basis. The Quality
Representatives are responsible for ensuring that processes needed for the QMS and EMS
are established, implemented, and maintained and for ensuring all employees are aware of
the customer requirements. The Quality Representatives also, have the responsibility to act
as a liaison with external customers/suppliers on matters relating to the QMS and EMS, as
applicable.
8.0 Management Review
8.1 Management review is performed on an annual basis at a minimum to ensure the QMS and
EMS continues to be suitable, adequate, and effective using inputs from the quarterly, as
applicable and annual reviews performed by each facility's quality representative. The
management reviews include:
Results of internal audits performed,
Results of compliance evaluations with legal requirements and with other subscribing
requirements for EMS registered locations,
Customer feedback,
Facilities' Quality and Environmental Performance, as applicable,
Extent to which objectives and targets have been met in EMS registered facilities,
Product and process nonconformities,
Suppliers’ quality performance,
Status of corrective and preventive actions,
Communication(s) from external interested parties, including complaints, in EMS registered
facilities,
Follow-up actions from previous management reviews,
Changes that could affect the QMS,
Changing circumstances, including developments in legal and other requirements related to
its environmental aspects in EMS registered facilities,
Recommendations for improvement.
8.2 The management review is utilized by Top Management to ensure the quality and
environmental policies and objectives continue to meet needs, identify areas for
improvement/change of the QMS and its processes and the EMS, as applicable and
product/service related to customer requirements and any additional resources needed.
9.0 Customer Satisfaction
9.1 Internal generated customer surveys, Industry Comparative Surveys, customer returns and
customer corrective action requests are used as a means of evaluating the customer's
perception of Avnet and whether the customer's requirements are met. This information
gathered from surveys is evaluated, analyzed by the Avnet customer satisfaction team, and
used to identify areas for improvement.
Business Use Only
10.0 Resources
10.1 Top management has identified and provided the resources needed to implement, maintain,
and continually improve the effectiveness of the QMS and EMS while enhancing customer
satisfaction by meeting customer and regulatory requirements. Personnel have also been
identified for the performance of work and verification activities. Management has identified
the equipment, buildings, work environment, communication systems, transportation, utilities,
information systems, security, computers, software and support services needed to ensure
customers’ requirements are consistently achieved.
11.0 Training
11.1 Documented procedures for identifying training needs and providing for the training of all
personnel performing activities affecting conformity to product requirements and/or that have
the potential to cause a significant environmental impact have been established and
maintained. Personnel performing specific assigned tasks are qualified based on appropriate
education, training, and/or experience as required. If employees do not have the required
education and/or experience, the necessary training is provided to ensure employees are
competent to perform the assigned tasks. The training provided is periodically assessed to
determine its effectiveness. Records of training and appropriate education or experience are
maintained.
11.2 Employees working in an EMS registered facility will be made aware of the importance of
conformity to the environmental policy and procedures and the EMS, the significant
environmental aspects and related actual or potential impacts associated with their work and
the benefits of improved personal performance, their roles and responsibilities in achieving
conformity with the requirements of the EMS, and the potential consequences of departure
from procedures.
12.0 Planning
12.1 Planning is used as a method of achieving the Quality Policy and objectives and the
Environmental Policy and objectives and targets; and as a means for meeting the
requirements for products, projects, or contracts. Planning is consistent with documented
requirements found throughout the quality and EMS systems. These requirements are found
within, but not limited to documents known as quality plans, business plans, marketing plans,
improvement plans, procedures, work instructions, Customer Inspection Instructions (CII's),
Special Handling Codes (SHC's), statement of work (SOW), customer specifications and
build procedures.
12.2 The Quality Manager at each EMS registered facility co-ordinates the identification of the
environmental aspects of the facilities activities, products and services that it can control and
those that it can influence and to determine those aspects that have or can have a significant
impact on the environment. The environmental aspects, impacts and significance will be
documented and kept up to date.
12.3 Each location registered to ISO14001 has identified the legal and other requirements
applicable for that location and how those requirements apply to its environmental aspects.
Business Use Only
13.0 Customer Requirements

13.1 Top Management ensures that customer requirements are determined and are met with an
aim of enhancing customer satisfaction. Management has provided for a sales team that has
the responsibility to communicate all information with the customers. Sales representatives
receive customer’s requirements electronically, verbally, or in writing. The customer's
requirements are reviewed to determine if capability exists to meet the requirements and if
the requirements are adequately defined prior to acceptance of a contract or order. This
includes any statutory and regulatory requirements applicable to the product. Any
differences between the actual contract or order requirements and those specified in the
quote are communicated to the customer and resolved prior to accepting the order. Any
changes to the order or contract are made via written deviations/waivers, purchase order
changes or verbal communications and are communicated to concerned functions within the
organization and with the customer in writing or by issuance of a new order or contract.
Records of the results of the review are maintained by the applicable sales representative.
14.0 Documentation
14.1 Quality and environmental management systems have been established, documented, and
maintained as a means of ensuring that product conforms to specified requirements and that
the environmental scope is defined and applicable to each applicable location. This includes
the preparation and effective implementation of documented quality and environmental
management system procedures and instructions, as required.
14.2 The process flow chart shown in Appendix III depicts the sequence and interaction of the
processes included in the overall QMS. The process flow for each facility's processes has
been developed and is controlled in that facility.
14.2.1 The main elements of the EMS and their interaction and reference to related
documents are shown in Appendix X.
14.3 The documentation outline is a three (3)-tier structure. A Quality Manual has been
developed, which documents the requirements of ISO9001 and ISO14001. The second level
Quality System and EMS (as applicable) Procedures, documents the requirements for
accomplishing the objectives of the Quality System and the documents necessary to ensure
effective planning, operation, and control of processes that relate to the significant
environmental aspects. The third level provides further detail as needed for specific business
operations and product lines and includes specific work instructions.
14.4 Quality and Environmental System procedures, plans, and work instructions have been
formally documented and maintained as defined in second level procedures. The range and
detail of the procedures are dependent on the complexity of the work, the methods used, and
the skills and training needed by personnel involved in performing the activity. Reference to
the Quality and Environmental Management System Procedures is as specified in Appendix
IV.
14.4.1 Appendix XI is intended to bridge the QMS of Integration facilities procedures.
15.0 Document Control
15.1 Documented procedures have been established and maintained to control documents that
relate to the requirements of the QMS and EMS, including documents needed to ensure
effective planning, operation, and control of processes, and as applicable documents of
external origin determined to be necessary for the planning and operation of the QMS, such
as military standards, manufacturers/suppliers’ standards/procedures, and customer
drawings, and any other applicable legal, statutory or regulatory documents. Documents
may be hard copy or electronic media.
15.2 Documents and data are reviewed and approved for adequacy by authorized personnel prior
to issue.
Business Use Only
15.3 Current revisions of appropriate documents are available at all locations where operations
essential to the effective functioning of the quality and environmental (as applicable) system
is performed. Invalid and/or obsolete documents are promptly removed from all points of
issue and/or use. If obsolete documents are retained for legal and/or knowledge
preservation, the documents are identified to prevent unintended use.
15.4 Documents are reviewed as required, changes made when required, and these
incorporations are coordinated with the customer and/or regulatory authority, as applicable.
Changes to documents are reviewed and approved by the same functions/organizations that
performed the original review and approval, unless specifically designated otherwise prior to
issuance.
16.0 Control of Records
16.1 Documented procedures for the identification, storage, protection, retrieval, retention time,
and disposition of records have been established and maintained. The records are
controlled, legible, readily identifiable, traceable and retrievable. Records are maintained to
demonstrate conformance to specified requirements and the effective operation of the quality
and environmental systems. When contractually specified by the customer, quality records
are made available to the customer or the customer's representative for evaluation for an
agreed period. Records may be in the form of any type of media, such as hard copy or
electronic media.
16.2 As a minimum, the following records are controlled:
Supplier/subcontractor Evaluations,
Traceability (Unique ID of product),
Customer Supplied Product report of damage/loss to customer,
Calibration results and verification,
Internal Audit,
Inspector’s Identification,
Nonconforming Product,
Results of corrective actions taken and follow-up activities,
Results of preventive actions taken and follow-up activities,
Periodic evaluation of compliance with applicable legal requirements (EMS only),
Periodic evaluation of compliance with other environmental requirements (EMS only).
17.0 Purchasing
17.1 Suppliers/subcontractors have been evaluated and selected based on their ability to meet
product and quality requirements including quality system and any specific quality assurance
requirements. Suppliers/subcontractors are periodically assessed and product quality
reviewed as a means of controlling suppliers and subcontractors. This control is dependent
upon the type of product, the impact of the supplied product/service on the quality of the final
product and where applicable on quality audit reports and/or quality records of the
performance of suppliers/subcontractors. Lists of acceptable suppliers and subcontractors
are maintained.
17.2 Purchasing documents contain information that clearly describes the product to be ordered.
This information includes where applicable type, class, grade, or other precise identification,
title or other positive identification and applicable issues of specifications, drawings, process
requirements, inspection instructions and other relevant technical data, including
requirements for approval or qualification of product, procedures, process equipment and
personnel, and title, number and issue of any quality system standard to be applied.
Business Use Only
17.3 When it has been determined to verify purchased product/services at the

supplier/subcontractor, the purchasing documents specify these verification arrangements
and the method for release of product. When specified in a customer contract, the customer
or his representative may verify at the supplier/subcontractor or upon receipt at Avnet that
product conforms to specified requirements. Verification by the customer does not absolve
Avnet of its responsibility to provide acceptable product nor does it preclude subsequent
rejection by the customer. When customer or his designated representative elects to
perform verification at the supplier/subcontractor's facility, such verification is not used as
evidence of effective control.
18.0 Control of Customer Supplied Product
18.1 Any customer supplied product used for value-add processing/warranty repair/rework is
identified, verified, protected, and safeguarded. Any customer supplied product that is lost,
damaged or is otherwise unsuitable for use is recorded and reported to the customer.
19.0 Product Identification and Traceability
19.1 The product supplied is identified with the manufacturer's part number, an internal part
number, and if applicable the customer’s part/drawing number.
19.2 When the customer specifies traceability as a requirement, the unique identification of
individual product or batches such as date codes/lot codes/serial numbers is provided. This
identification is recorded on the applicable traceability quality record.
19.3 The status of the product throughout all processing including all monitoring and
measurement is maintained by use of reject tags, acceptance labels, work orders, shippers,
invoices, travelers, routers, shop tickets, etc. These documents include the identification of
the employee performing the operation/inspection/test.
20.0 Process Control
20.1 The distribution and production processes which directly affect quality and the operations
that are associated with the significant environmental aspects have been identified and
planned and are carried out under controlled conditions.
20.1.1 Any processes that affect product conformity, which are outsourced are
controlled via audits, procedures/work instructions, and/or inspections of the
process and/or results of the process performed, as applicable.
20.2 Documented procedures/work instructions defining the requirements of the distribution, value
add and the production/assembly processes have been developed and maintained at each
location where the absence of such procedures could adversely affect quality. These
procedures/work instructions include any required requirements from statutory and
regulatory documents. Procedures and work instructions defining the requirements for
support groups such as sales, purchasing and information services are maintained and
controlled by the specific support group, as required using their own method of control.
20.2.1 Documented procedure(s) have been established, implemented and maintained
to control situations where their absence could lead to deviation from the
environmental policy, objectives and targets and to stipulate the operating
criteria.
20.2.2 Procedures have been established, implemented and maintained related to the
identified significant environmental aspects of goods and services used and
communicating these procedures and requirements to applicable suppliers and
subcontractors.
20.3 Suitable distribution, value-add, production/assembly, and monitoring and measuring
equipment is in use at each location. Preventive maintenance is performed on the required
equipment to ensure continual operation.
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20.4 Monitoring, measuring and control of suitable process parameters and product
characteristics are performed, where applicable.
20.5 The work environment is controlled to the extent necessary to achieve conformity of product
requirements or as specified in regulatory documents.
21.0 Inspection and Testing
21.1 Documented procedures for inspection and testing activities have been established and
maintained in order to verify that the specified requirements for the product are met. The
required inspection and testing and the records to be established are detailed in these
procedures.
21.2 An inspection is performed upon receipt of product from the suppliers. No material may be
used or processed until it has been inspected or otherwise verified upon receipt as
conforming to specified requirements.
21.3 In-Process Inspection and Testing is performed in accordance with established documented
procedures as applicable to the operations being performed.
21.4 Final inspection and/or testing are performed in accordance with documented procedures to
provide the evidence of conformance of the finished product to the specified requirements.
Documented procedures for final inspection and testing require that all specified inspections
and tests including those specified either upon receipt of product or in-process have been
carried out and that the results meet specified requirements.
21.5 Records provide evidence that the product has been inspected and/or tested, clearly show
that the product has passed or failed the inspection and/or test according to the defined
acceptance criteria and identify the inspection authority responsible for the release of
product.
21.6 Any material rejected at Receiving, In-Process, or Final Inspection and Test, is positively
identified, segregated from the flow of acceptable product, and processed in accordance with
requirements specified in the Control of Nonconforming Product procedure. Documented
procedures ensure that only after product has been subjected to all required inspections and
tests, required data recorded and reviewed is the product identified as acceptable, and
permitted to progress to the next process step. No product is dispatched until all the activities
specified in the documented procedures have been satisfactorily completed and the
associated data and documentation is available and authorized.
22.0 Control of Monitoring and Measuring Equipment
22.1 Documented procedures to control, calibrate, and maintain inspection, measuring and test
equipment (including test software) used to demonstrate the conformance of product to the
specified requirements and/or used to monitor and measure key characteristics that can
have a significant environmental impact, as applicable have been established and
maintained. All measuring and test equipment that can affect product quality or is used to
monitor and measure key characteristics that can have a significant environmental impact,
has been identified, calibrated or verified or both, and/or adjusted at prescribed intervals, or
prior to use, against certified equipment having known valid relationship to international or
nationally recognized standards. If no such standards exist, the basis used for calibration is
documented in calibration procedures.
22.2 The inspection, measuring and test equipment is documented in records and/or procedures,
which include the details of equipment type, unique identification, location, frequency of
checks, check method, acceptance criteria and the action to be taken when results are
unsatisfactory. The equipment is identified with a sticker or other approved suitable indicator
to show the calibration status and identification of equipment.
22.3 An assessment is made and documented on the validity of previous inspection and test
results when inspection, measuring, or test equipment is found to be out of tolerance when
calibrated. Appropriate action is taken on equipment and any product affected.
Business Use Only
22.4 Inspection, measuring and test equipment is calibrated/adjusted in the same environment as
used and is protected from damage and deterioration during handling, maintenance, and
storage. Safeguards are applied to inspection, measuring and test equipment, including both
test hardware and test software, to prevent adjustments, which would invalidate the
calibration setting.
23.0 Control of Nonconforming Product
23.1 Documented procedures have been established and maintained to ensure that product that
does not conform to specified requirements is prevented from unintended use and the
individuals who have the responsibility and authority for the disposition of the product is
specified. Control is provided for identification, documentation, evaluation, segregation (when
practical), and disposition and for notification to the functions concerned.
23.1.1 Documented procedures have been established, implemented and maintained
for dealing with actual or potential nonconformities associated with environmental
issues. The procedure defines the process for identifying and correcting the
nonconformity and action(s) taken to mitigate its environmental impacts,
investigating nonconformities, determining their causes and taking actions in
order to avoid recurrences.
23.2 Nonconforming product may be reworked to meet the specified requirements, accepted with
or without repair by waiver, rejected or scrapped. The proposed use or repair of product,
which does not conform to specified requirements, is reported for waiver to the customer or
customer's representative. Repaired and/or reworked product is re-inspected to ensure it
complies with the specified requirements.
23.3 The use of a positive recall system is used when deemed prudent and is documented as part
of containment in associated Avnet Quality Feedback System responses, as applicable.
Where applicable, organization specific procedures have been created.
23.4 Any product found to be defective after shipment to the customer may be returned for
evaluation as authorized by the applicable sales and marketing representative.
24.0 Corrective Action and Preventive Action
24.1 Documented procedures for implementing corrective and preventive action have been
established and maintained.
24.2 Corrective actions are taken when corrective action requests are received from customers,
when problems occur in process, with product, process, quality or environmental system, or
reported environmental issues and when audit findings are identified. The nonconformity
identified is corrected, an investigation conducted to determine the root cause and an action
implemented to prevent the recurrence of the nonconformity. Results of the investigation
and the corrective action taken are documented and records maintained. Follow-up is
performed on corrective action responses to ensure that the corrective action was
implemented and effective in correcting the nonconformity.
24.2.1 Actions taken for environmental issues or EMS nonconformities are appropriate
to the magnitude of the problems and the environmental impacts encountered.
24.2.2 Any changes to the EMS are made, as necessary as a result of the actions taken
for identified nonconformities.
24.3 Appropriate sources of information such as processes and work operations that affect
product quality, waivers, audit results, quality and environmental records, and customer
complaints are periodically reviewed to detect, analyze, and eliminate potential causes of
nonconformities. The records maintained include the analysis performed in determining the
preventive action identified, the steps needed to be performed for implementation, the
controls to be applied to ensure it is effective and the review to determine effectiveness of
the preventive action implemented.
Business Use Only
25.0 Handling, Storage, Preservation, Packaging, and Delivery

25.1 Documented procedures for handling, storage, packaging, preservation, and delivery of
product have been established and maintained in order to maintain conformity to
requirements. The methods used to handle product prevents damage and/or deterioration.
Designated storage areas and stockrooms to prevent damage or deterioration of product
pending use and delivery are maintained. Appropriate methods for authorizing receipt to and
dispatch from such areas are utilized. In order to detect deterioration, the condition of
product is assessed at appropriate intervals.
26.0 Internal Audits
26.1 Documented procedures for planning and implementing internal quality and environmental
system audits to verify whether the QMS and EMS and related activities and results comply
with planned arrangements and to determine the effectiveness and implementation of the
quality and environmental management systems have been established and maintained.
Internal quality and environmental management system audits are scheduled on the basis of
the status and importance of the activity to be audited and are carried out by personnel
independent of those having direct responsibility for the activity being audited.
26.2 Results of audits are recorded and are brought to the attention of the personnel having
responsibility for the area audited. Management personnel responsible for the area audited
shall ensure that corrective actions and necessary corrections on deficiencies found during
the audit to eliminate detected nonconformities and their causes are taken without undue
delay. Follow-up audit activities to determine implementation and effectiveness of the
corrective action taken are verified and recorded. The results of internal quality and
environmental audits are reported to the management representative for inclusion in the
management review.
27.0 Statistical Techniques
27.1 The need for statistical techniques required for establishing, controlling and verifying process
capability, and product characteristics and to continually improve the effectiveness of the
QMS has been identified. Avnet has established and maintains documented procedures to
implement and control the application of the statistical techniques identified.
27.2 Data collected from processes and products is analyzed to demonstrate continual
improvement of the effectiveness of the QMS and areas where continual improvement of the
QMS can be made. Analysis of the data provides information on customer satisfaction,
conformity to product requirements, characteristics and trends of processes and products
including opportunities for preventive action and suppliers.
27.3 Each location compliant to ISO14001 will identify the monitoring and measuring to be
performed on the identified key characteristics of its operation that can have a significant
environmental impact.
28.0 Continual Improvement
28.1 Continual improvement of the effectiveness of the QMS and EMS is evaluated through the
use of the quality and environmental policies, quality objectives, environmental objectives
and targets, audit results, analysis of data, corrective and preventive actions and
management review.
29.0 Design and Development (Not Applicable)
30.0 Emergency Preparedness and Response (EMS)
30.1 Procedures have been established, implemented and maintained to identify potential
emergency situations and potential accidents that can have an impact on the environment
and the method for responding to them. Any emergency situations or accidents will be
responded to immediately to prevent or mitigate associated adverse environmental impacts.
Business Use Only
30.2 A review is periodically performed, where necessary to revise emergency preparedness and
response procedures, in particular, after an occurrence of an accident or emergency
situation.
30.3 Where practicable, tests will be performed to check for emergency preparedness and
response.
31.0 Evaluation of Compliance (EMS)
31.1 Compliance with applicable legal and other requirements is periodically performed by an
auditor knowledgeable in the applicable legal and requirements at each facility registered to
ISO14001. A report is generated and corrective actions taken. The report of the evaluation
results and the corrective actions taken are kept on file.
32.0 Communications (EMS)
32.1 Employees at all levels located in facilities registered to ISO14001 will receive EMS
awareness training, which will include information on the facility identified environmental
aspects and environmental programs.
32.2 Periodically employees will receive updates regarding the performance of the environmental
programs and the achievement of the objectives and targets.
32.3 Requests for information received by the facilities regarding the significant environmental
aspects and EMS will be forwarded to Avnet’s legal department, as applicable.
33.0 Supplemental Requirements for AS9100 Registered Facilities

This section is supplemental and is intended to be used in conjunction with sections 1.0 through
29.0 in facilities registered to AS9100.
Documentation (AS9100 – 4.2.1)
33.1 QMS documentation is available to all Avnet personnel on the Avnet Quality Assurance
website. Managers of each affected area are notified of documents and changes to
documents via electronic broadcasts and are responsible to notify their applicable
employees.
33.2 The process flow charts shown in Appendix VII, Appendix VIII, and Appendix IX depict the
sequence and interaction of the processes included in the overall QMS at Logistics, Value-
Add, and Programming facilities. The process flow for each facility's processes has been
developed and is controlled in that facility.
33.3 The relationship between the requirements of AS9100 and the documented procedures are
defined in Appendix VI.
Records (AS9100 – 4.2.4)
33.4 Records supplied by product suppliers are maintained in accordance with the Quality
Records procedure listed in Appendix VI. Records retained by the suppliers are maintained
and controlled by the supplier’s internal procedures.
Customer Focus (AS9100 – 5.2)
33.5 Product conformity and on-time delivery performance is measured and reported during
management review to Top Management. Appropriate action is taken if planned results are
not or will not be achieved.
Management Representative (AS9100 – 5.5.2)
33.6 The Management Representative has been given the responsibility and authority to resolve
matters pertaining to quality and has unrestricted access to Top Management.
Business Use Only
Planning of Product Realization (AS9100 – 7.1)

33.7 In planning of product realization the following is determined as appropriate:
a) Configuration management appropriate to the product.
b) Resources have been identified to support the use and maintenance of the
product for assembly.
Project Management (AS9100 – 7.1.1)
33.8 As appropriate to Avnet and the product, Avnet plans and manage product realization in a
structured and controlled manner to meet requirements at acceptable risk, within resource
and schedule constraints.
Risk Management (AS9100 – 7.1.2)
33.9 Avnet has established, implemented and maintains a process for managing risk to the
achievement of applicable requirements that includes, as appropriate to the organization and
the product:
a) assignment of responsibilities for risk management,
b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance),
c) identification, assessment and communication of risks throughout product
realization,
d) identification, implementation and management of actions to mitigate risks that
exceed the defined risk acceptance criteria, and
e) acceptance of risks remaining after implementation of mitigating actions.
Configuration Management (AS9100 – 7.1.3)
33.10 Avnet has established, implemented and maintains a configuration management process
that includes, as appropriate to the product:
a) configuration management planning,
b) configuration identification,
c) change control,
d) configuration status accounting, and
e) configuration audit.
Configuration management is not applicable to the product supplied by Avnet. Configuration
management for the product is the responsibility of the customer or component
manufacturer. Configuration management is the Quality Management System as defined in
this Quality Manual Supplement and Appendix VI.
Control of Work Transfers (AS9100 – 7.1.4)
33.11 Avnet has established, implemented and maintains a process to plan and control the
temporary or permanent transfer of work (e.g., from one Avnet facility to another, from Avnet
to the Supplier, from one supplier to another supplier) and verifies the conformity of work to
requirements.
Review of Requirements Related to the Product (AS9100 – 7.2.2)
33.12 Special requirements of the product are determined during the quoting process.
33.13 Risks (e.g., new technology, short delivery time frame) have been identified during the
quoting process.
Business Use Only
Purchasing Process (AS9100 – 7.4.1)

33.14 When specified by the contract, products, materials, and services are purchased from
customer approved sources. The conformity of the purchased products is ensured even
though customer designated sources are specified.
33.15 Avnet approved suppliers of product are listed on the company’s line card including the
products available from each supplier.
33.16 Periodic reviews are performed with suppliers on the Suppliers performance. Records of the
reviews are maintained by the Product Business units.
33.17 Suppliers quality performance is reviewed during the periodic performance review and
actions assigned for improvement. Supplier Corrective Action Requests (SCAR’s) may be
requested for poor performance through the Avnet corrective action system.
33.18 When specified in the contract, uses of customer approved special process sources are
used.
33.19 The processes, responsibilities and authorities for the approval status decision, changes to
the approval status and conditions for a controlled use of suppliers depending on the
supplier’s approval status are defined, as required.
33.20 The risk has been determined and is managed when selecting and using suppliers.
33.21 Suppliers of materials used directly in the assembly of products are purchased from the OEM
manufacturer, the distributor for the products specified in the OEM specifications or as
directed by the customer for custom customer assemblies. A list of these suppliers is
maintained by the applicable Avnet assembly facility.
Purchasing Information (AS9100 – 7.4.2)
33.22 Where appropriate the following items are included in the purchase documents:
a) Identification and revision status specifications, drawings, process requirements,
inspection/verification instructions, and other relevant technical data,
b) Requirements for design, test, inspection, verification (including production
process verification), use of statistical techniques for product acceptance, and
related instructions for acceptance, and as applicable, critical items key
characteristics,
c) Requirements for test specimens (e.g., production method, number, storage
conditions) inspection/verification, investigation or auditing,
d) Requirements regarding the need for suppliers to notify Avnet of nonconforming
product and to obtain Avnet’s approval for nonconforming product disposition, for
supplier notification of changes in product and/or process, changes of suppliers,
changes of manufacturing facility location, and where required, obtain Avnet’s
approval, and to flow down applicable requirements to sub-tier suppliers,
e) Record retention requirements, and
f) Right of access to all applicable areas in suppliers’ facilities by Avnet, customers
and regulatory authorities involved in the order and to all applicable records.
Verification of Purchased Product (AS9100 – 7.4.3)
33.23 Purchased product is not allowed to be released for use until it has been verified as
acceptable. The use of a positive recall system is used when deemed prudent and is
documented as part of containment in associated Avnet Quality Feedback System
responses, as applicable. Where applicable, organization specific procedures have been
created.
33.24 Avnet does not delegate verification of purchased product to the supplier.
Business Use Only
Control of Production and Service Provision (AS9100 – 7.5.1)

33.25 Key characteristics, in-process verification, which cannot be performed at a later stage,
design, manufacture, and use of tooling and special processes, are not applicable to Avnet’s
business.
33.26 Product during assembly and/or programming is accounted for by notations on the lot
traveler. This includes quantities, splits, rework, and rejects.
33.27 All production steps and inspections/tests are documented on the lot traveler.
33.28 A documented program for the prevention, detection, and removal of foreign objects is
maintained.
33.29 Shelf life controls are in place for applicable materials use in assembly. No utilities or other
supplies affect product conformity to product requirements.
33.30 Workmanship standards have been developed as applicable.
33.31 Planning Considerations, as appropriate:
a) No critical items or process controls with key characteristics have been identified
nor are applicable to Avnet’s business.
b) No tooling is designed, manufactured or used to measure variable data.
c) In-process inspection/verification points have been identified within the applicable
assembly work instructions.
d) No special processes have been identified.
Production Process Verification (AS9100 – 7.5.1.1)
33.32 Avnet uses a representative part from the first part produced for custom assembly and
programming orders to verify the process, production documentation and tooling are capable
of producing parts and assemblies that meet customer requirements. This process is
repeated when changes occur that invalidate the original results (e.g., engineering changes,
customer requirement changes, equipment changes, program changes). This verification
may also be satisfied through a first article process.
Control of Production Process Changes (AS9100 – 7.5.1.2)
33.33 Changes to assembly and programming processes, production, equipment, tools or software
programs are made through the document control system and/or through a first article
approval process. Any changes made to processes must be approved by the same
functions specified in the document control and/or first article procedure.
Control of Production Equipment, Tools, and Software Programs (AS9100 – 7.5.1.3)
33.34 All new equipment, tools and software are validated prior to use and periodically inspected
per the calibration and preventive maintenance procedures. Equipment and tools are stored
to prevent any damage or deterioration.
Post Delivery Support (AS9100 – 7.5.1.4)
33.35 Servicing is not applicable to Avnet’s operations.
Identification and Traceability (AS9100 – 7.5.3)
33.36 Product configuration is the responsibility of the product supplier and/or customer. Product
received from the product supplier is received with the supplier’s part number. Product built
to customer drawings maintains the customer’s part number. These numbers are maintained
through-out all processing.
33.37 A documented procedure has been established which defines the controls required for the
use of stamps, electronic identification and passwords used to identify employees.
Business Use Only
Preservation of Product (AS9100 – 7.5.5)

33.38 Provisions have been included in documented procedures and work instructions for the
following, as applicable:
a) cleaning;
b) prevention, detection and removal of foreign objects;
c) special handling for sensitive products;
d) marking and labeling including safety warnings;
e) shelf life control and stock rotation; and
f) special handling for hazardous materials.
Control of Monitoring and Measuring Equipment (AS9100 – 7.6)
33.39 The calibration system includes an equipment recall list of all equipment requiring calibration
used for inspection. The system requires all employees owned and customer supplied
equipment to be included in the calibration system. The list and/or records of calibration
include calibration procedure used, equipment type, unique identification, location, frequency
of checks, check method, and acceptance criteria.
33.40 Environmental conditions are suitable for the calibrations, inspections, measurements, and
tests being carried out. The temperature and humidity of the environment during calibration
is recorded on the Certificate of Calibration. Environmental conditions are monitored during
device programming and assembly as appropriate to the product.
33.41 An equipment list is maintained, which includes the calibration due date of each piece of
calibrated equipment. The list is used to recall each piece of equipment requiring calibration
or verification when due.
Customer Satisfaction (AS9100 – 8.2.1)
33.42 As a minimum, the information to be monitored and used to evaluate customer satisfaction
includes product conformity, on-time delivery performance, customer complaints and
corrective action requests. Results of the monitoring and evaluations of the data are
reviewed to address deficiencies identified by the evaluations and assess the effectiveness
of the results.
Monitoring and Measurement of Processes (AS9100 – 8.2.3)
33.43 If any process nonconformities are detected, corrective action is promptly taken to correct
the nonconforming process, evaluate if the process has produced any nonconforming
product, determine if the process nonconformity is limited to a specific occurrence or if it
could have affected other processes or products, and identify and control the nonconforming
product in accordance with the applicable nonconforming product procedure.
Monitoring and Measurement of Product (AS9100 – 8.2.4)
33.44 Inspection requirements are documented in procedures and work instructions. The
procedures include criteria for acceptance and/or rejection, where in the process the
inspections and/or tests are performed, records to be maintained and the inspection and/or
test equipment used. If required, test records shall show actual test results data and
indication of acceptance or rejection at a minimum.
33.45 No key characteristics have been identified.
33.46 When not specified by the customer, supplier and/or regulatory agency, sample plans used
are statistically valid and appropriate for use based on recognized statistical documented
industry standards. The acceptance allowed is zero.
Business Use Only
33.47 The use of a positive recall system is used when deemed prudent and is documented as part
of containment in associated Avnet Quality Feedback System responses, as applicable.
Where applicable, organization specific procedures have been created.
33.48 If product qualifications are required, the records shall provide evidence that the product
meets defined requirements.
33.49 All documents required to accompany the product are included at shipping. Documents
required to accompany product are specified in procedures, work instructions, and/or special
instructions on each order. Each order requiring accompanying documents is checked to
ensure documents are available at shipping. Documents are placed in a protective envelop
identified as containing documents.
Control of Nonconforming Product (AS9100 – 8.3)
Note: Nonconforming product includes product returned from the customer.
33.50 The documented procedure for handling and control of nonconforming product defines the
responsibility and authority for review and disposition of nonconforming product and the
process for approval of personnel making these decisions.
33.51 Customers will be notified of product shipped to them which has been reported as
nonconforming by the product supplier or identified by Avnet, which affects reliability or
safety. Notification shall include a clear description of the nonconformity, which will include
as necessary parts affected, customer and/or organization part numbers, quantities, and
date(s) delivered.
33.52 In dealing with nonconforming product the necessary actions to contain the effect of the
nonconformity on other processes or products are taken.
33.53 Use-as-is or repair dispositions are not to be used unless specifically authorized by the
customer, if the product is produced to customer design or the nonconformity results in a
departure from the contract requirements.
33.54 Product disposition for scrap shall be conspicuously and permanently marked, or positively
controlled, until physically rendered unusable.
Continual Improvement (AS9100 – 8.5.1)
33.55 Continual improvement projects are followed-up on to ensure that they are implemented and
effective.
Corrective Action (AS9100 – 8.5.2)
33.56 Corrective actions are requested from the supplier when it has been determined that the
supplier is responsible for the nonconformity.
33.57 Corrective actions which have not been provided in a timely manner are escalated to the
next higher level of management. A new corrective action is issued when the original
corrective action response is found to be ineffective in correcting the problem.
33.58 Corrective action evaluations include determining if additional nonconforming product exists
based on the nonconformities and taking further action, if required.
34.0 Supplemental Requirements for ISO 13485 Registered Facilities

29.0 in facilities registered to ISO 13485.
Business Use Only
Quality Management System Requirements (ISO 13485 – 4.1)

Note: Documents which define the key ATS business processes are specified in Appendix XI.
Note: Documents which define the key Cable and Connector Assembly Business processes are specified
in Appendix IV.
Documentation (ISO 13485 – 4.2.1; 4.2.3; 4.2.4)
34.1 No documents specified by national or regional regulations have been identified for
application to Avnet’s business. When such requirements become known, they will be
implemented into the Avnet’s build instructions.
34.2 Files are maintained for each type or model of medical device which either contains or
identifies documents defining product specifications and QMS requirements. These
documents define the complete manufacturing process.
34.3 At least one copy of obsolete controlled documents and changed process documents are
retained as specified by the customer, regulatory agency and Avnet, as applicable.
34.4 Changes to documents are reviewed and approved by the original approving function or by
an alternate designated function that has pertinent background information upon which to
base the decision for a change.
34.5 Records are retained for a period of time at least equivalent to the lifetime of the medical
device, as defined in Avnet procedures, but not less than two years from the date of product
release or as specified by relevant regulatory requirements.
Management Responsibility (ISO 13485 – 5.5.1)
34.6 The interrelation of personnel who manage, perform and verify work affecting quality has
been defined by top management. Job descriptions are utilized to define the responsibility
and authority for employees through the organization. The interrelation of personnel who
manage, perform, and verify work affecting quality and who need the independence, freedom
and authority to perform these tasks are defined in key process procedures.
Management Representative (ISO 13485 – 5.5.2)
34.7 The Management Representative has been given the responsibility to promote awareness of
regulatory requirements throughout the organization. Currently there are no projects
requiring special regulatory requirements for medical customers. When projects are
identified that require special regulatory requirements, the management representative will
be notified.
Management Review (ISO 13485 – 5.6.2; 5.6.3)
34.8 New and or revised regulatory requirements will be included as an input to management
review.
34.9 Improvements identified to maintain and/or enhance the effectiveness of the QMS and
processes will be included as an output from management review.
Provision of Resources (ISO 13485 – 6.1)
34.10 Resources are provided to meet regulatory and customer requirements.
Infrastructure (ISO 13485 – 6.3)
34.11 Requirements for maintenance activities have been documented, including the required
frequency when the maintenance activities or lack of maintenance activities could affect
product quality. Records of the maintenance performed are maintained as required by the
records procedure.
Business Use Only
Work Environment (ISO 13485 – 6.4)

34.12 Documented requirements for health, cleanliness and clothing of personnel have not been
established, since contact of personnel and the product or work environment does not
adversely affect the quality of the product. Documented requirements have been established
for ESD controls, where appropriate for prevention of damage due to electrostatic discharge.
Other considerations may be implemented based on customer specific requirements.
34.13 No work environment conditions have been identified that could have an adverse effect on
product quality; therefore requirements for work environment conditions, monitoring and
controlling these environmental conditions have not been documented in procedures and
work instructions. Documented requirements have been established for ESD controls, where
appropriate for prevention of damage due to electrostatic discharge. Other considerations
may be implemented based on customer specific requirements.
34.14 No personnel have been identified to work temporarily under special environmental
conditions within the work environment to require appropriate training or supervised by
trained personnel.
34.15 Product supplied does not have the potential to contaminate other product, the work
environment or personnel.
The organization does not supply invasive medical devices; therefore work environment controls
applicable to devices of that nature in terms of health, cleanliness and sterilization (and training and
monitoring to those requirements are not applicable).
Planning of Product Realization (ISO 13485 – 7.1)
34.16 Verification and validation of product design including risk management resides with the
customer, as the customer maintains design ownership.
34.17 Risk management for the applicable product realization processes are defined, assessed,
and documented. Records of the risk assessment are maintained in accordance with the
records procedure.
Review of Requirements Related to the Product (ISO 13485 – 7.2.2)
34.18 All product requirements, including those given verbally are documented for subsequent
review and approval.
Customer Communication (ISO 13485 – 7.2.3)
34.19 Central point of contact has been established in departmental areas (i.e. sales, engineering,
etc.) for order handling/status/and change requests and disseminating advisory notices.
Purchasing Process (ISO 13485 – 7.4.1)
34.20 Procedures have been established to control the quality of purchased products from
franchised suppliers, non-franchised suppliers and value added subcontractors and to
ensure that purchased product and/or services conform to specified requirements.
Purchasing Information (ISO 13485 – 7.4.2)
34.21 Traceability is maintained from receiving to shipping to the customer, as applicable and
records maintained.
Verification of Purchased Product (ISO 13485 – 7.4.3)
34.22 Records of the verification of the product are maintained in accordance with the records
retention procedure.
Control of Production and Service Provision-General Requirements (ISO 13485 – 7.5.1.1)
34.23 Work instructions are available as necessary to adequately perform work.
Business Use Only
34.24 Labeling and packaging requirements have been implemented and controlled as required by
customer requirements within build instructions.
34.25 Identification and traceability of individual batches of medical devices is maintained. This
includes traceability of system components to the assembly level, where required. The
identification and traceability is recorded and identifies the amount manufactured and
amount approved for distribution. The record is verified and approved.
Control of Production and Service Provision-Specific Requirements
(ISO 13485 – 7.5.1.2; 7.5.1.2.1; 7.5.1.2.2; 7.5.1.2.3; 7.5.1.3)
Clauses 7.5.1.2 through 7.5.1.3 are not applicable to Avnet’s business.
Validation of Processes for Production-General Requirements (ISO 13485 – 7.5.2.1)
34.26 All production processes are validated internally and as requested by the customer.
34.27 Criteria for the review and approval of the processes are defined in the build instructions.
34.28 Equipment is designated within the build instruction and controlled per the equipment
calibration and maintenance process. Personnel are qualified in accordance with the training
process.
34.29 Methods and procedures have been documented, implemented and controlled per the
document control process.
34.30 Control of records and the maintenance of the required records are as specified in the
records procedure and records retention chart.
34.31 Revalidation as applicable is specified within the build instructions.
34.32 Validation of computer software is documented unless deemed as inappropriate.
34.33 Records of computer software validation are maintained in accordance with the records
procedure unless deemed as inappropriate.
Particular Requirements for Sterile Medical Devices (ISO 13485 – 7.5.2.2)
No sterile medical devices are processed by Avnet.
Identification (ISO 13485 – 7.5.3.1)
34.34 The identification of product is documented within the integration and packaging procedures.
34.35 A documented procedure defines how medical product that has been shipped and returned
is identified and distinguished from conforming product.
Traceability (ISO 13485 – 7.5.3.2; 7.5.3.2.1; 7.5.3.2.2)
34.36 A documented procedure has been established for traceability. The procedure defines the
requirements for product traceability and the records to be maintained.
Avnet does not produce any active implantable medical devices or implantable medical
devices.
Status Identification (ISO 13485 – 7.5.3.3)
34.37 Identification of the status of the product is maintained throughout production, storage,
installation, and servicing of product. This includes inspection and test status. Product is
only released after it has met all inspection and test criteria; where deviation to a process is
required, it is documented through issuance of a Quality Bulletin.
Preservation of Product (ISO 13485 – 7.5.5)
34.38 Documented procedures and/or work instructions are maintained for preserving the
conformity of product during internal processing and delivery to the customer.
Business Use Only
34.39 Where shelf life product is used it is controlled and conditions for control are documented in
procedures and work instructions, as applicable.
Control of Monitoring and Measuring Devices (ISO 13485 – 7.6)
34.40 Subject matter experts determine the monitoring and measurement activities appropriate to
demonstrate conformity of product to predetermined requirements that are documented
within procedures and build instructions or subsequent customer inspection instructions.
Measurement, Analysis, and Improvement-General (ISO 13485 – 8.1)
34.41 Internal audits are conducted with the goal of continually improving the processes and
maintaining the effectiveness of the QMS.
Feedback (ISO 13485 – 8.2.1)
34.42 Avnet continually seeks feedback from customers to determine if their requirements are
achieved. This feedback takes place during the prototype process and post build vehicles
for product, process and business related feedback.
34.43 Customer Advisory Council and Avnet Customer Loyalty Program activities serve to
proactively seek feedback from customers on a regular basis. Corrective and preventive
actions are recorded within reports and the Process Improvement Request process.
34.44 No national or regional regulations have been identified that require Avnet to gain experience
from the post-production phase for inclusion into the feedback system.
Active Implantable Medical Devices and Implantable Medical Devices (ISO 13485 – 8.2.4.2)
Not applicable to the products supplied. Implantable devices are not being supplied.
Control of Nonconforming Product (ISO 13485 – 8.3)
34.45 The responsibility for review and disposition including acceptance of product under
concession is only authorized if regulatory requirements have been met. Records of the
identity of the person (s) authorizing the concession are maintained.
34.46 Instructions for rework, including re-inspection are accessible to and utilized by the
appropriate personnel. Reworked product is re-inspected in accordance with the designated
processes, build instructions and/or applicable quality plans, work instructions, and
workmanship standards. The documentation for rework is subject to the same review and
approval as the original build documentation.
Analysis of Data (ISO 13485 – 8.4)
34.47 Data analyzed to determine the effectiveness of the QMS includes process, product,
customer satisfaction (feedback), supplier performance, and trends identifying opportunities
for improvement within the business as described in the Analysis of Data procedure.
34.48 Records of the results of the analysis of data are maintained in accordance with the record
retention procedure.
Improvement (ISO 13485 – 8.5.1)
34.49 The nonconforming procedure includes the requirements for issue and implementation of
advisory notices.
34.50 Customer complaint investigations are recorded and maintained within the corrective action
system. If a customer complaint is not followed by a corrective/preventive action, the reason
shall be authorized and recorded. If investigations determine that the component
manufacturers or subcontractors contributed to the customer complaint, corrective actions
shall be obtained from them.
34.51 Notification to regulatory authorities of any adverse events shall be made as required by
national or regional regulations require.
Business Use Only
Corrective Action (ISO 13485 – 8.5.2)

34.52 Documents are updated, if appropriate, as a result of actions identified.
34.53 Results of corrective action investigations are recorded.
Preventive Action (ISO 13485 – 8.5.3)
34.54 Results of preventive action investigations are recorded.
34.55 Preventive action taken and its effectiveness are reviewed.
35.0 Supplemental Requirements for TS16949 Registered Facilities

29.0 in facilities maintaining compliance to TS16949.
Quality Management System-General Requirements (TS16949 – 4.1.1)
35.1 When product is sent to subcontractors for additional processing, the subcontractors are
audited and approved to ensure customers’ requirements are met, unless the customer
specifies a specific subcontractor to be used.
Documentation (TS16949 – 4.2.3.1; 4.2.4.1)
35.2 Customer drawings, specifications, and/or procedures are reviewed, distributed and
implemented when received by the sales organization. This review does not exceed two
working weeks and records maintained of the date the change is implemented into
production.
35.3 As a minimum, retention times satisfy regulatory and customer requirements.
35.4 The process flow chart shown in Appendix V depicts the sequence and interaction of the
processes included in the overall QMS at Programming facilities. The process flow for each
facility's processes has been developed and is controlled in that facility.
Process Efficiency (TS16949 – 5.1.1)
35.5 Top management reviews the value added processes and support processes to ensure their
effectiveness and efficiency during the management review process.
Quality Objectives (TS16949 – 5.4.1.1)
35.6 Quality Objectives and measurements are defined by top management, included in the
Strategic Business Plan and are used to deploy the Quality Policy. The Strategic Business
Plan is considered to be a company proprietary document.
35.7 The Facility Quality Assurance Manager/ Operations Manager are promptly informed of
Products or processes that do not conform to requirements.
35.8 All employees are responsible for quality and have been given the authority to stop
production to correct quality problems.
35.9 The shift supervisors on each shift have been delegated the responsibility for ensuring
product quality.
Customer Representative (TS16949 – 5.5.2.1)
35.10 Top Management has given Sales and Marketing Representatives (SMR’s) the responsibility
and authority to identify any customer requirements including customer special
characteristics during the contract review process.
35.11 Top Management identifies quality objectives for the company, then, delegates the
dissemination of the objectives and any related training to the lower tiers of management at
each location.
Business Use Only
35.12 Facility Quality Assurance Managers at each location have been given the responsibility to
resolve corrective actions and ensure preventive actions are implemented.
Management Review (TS16949 – 5.6.1.1; 5.6.2.1)
35.13 The management reviews include all elements of the quality management system,
performance trends as part of continual improvement, monitoring of quality objectives and
the reporting and evaluation of the cost of poor quality. The records of the management
reviews are maintained by the Management Representative and include achievement of the
business plan quality objectives and customer satisfaction with the product supplied.
35.14 If the customer has provided information on potential field failures, an analysis of the failure
and its impact on quality, safety, or the environment is included in the management review.
Competence, Awareness, and Training (TS16949 – 6.2.2.2; 6.2.2.3; 6.2.2.4)
35.15 A documented procedure has been established and is maintained for identifying training
needs and achieving competence of all personnel performing activities affecting product
quality. Personnel performing specific assigned tasks have been qualified on the basis of
education, training, skills, and/or experience, as required. Training is provided, as
appropriate, to satisfy customer specific requirements.
35.16 On the job training is provided for all jobs affecting quality, this includes any temporary
employees. All employees whose work affects quality are informed of the consequences to
the customer when nonconformances to customer requirements occur.
35.17 Employees are motivated to achieve quality objectives, to make continual improvements and
create an environment to promote innovation, through the use of the RESULTS, POP, and
Circle of Excellence programs as a minimum. The process includes the promotion of quality
and technological awareness throughout the whole organization through company meetings,
training and awareness sessions. The extent to which employees are aware of the
relevance and importance of their activities and how they contribute to the achievement of
the quality objectives is measured through personnel reviews and quality audit results.
Infrastructure (TS16949 – 6.3.1; 6.3.2)
35.18 A Multi-disciplinary approach is used for the planning of new plant, facilities, and equipment.
Plant layouts optimize material travel, handling, and value-added use of floor space, and
facilitate synchronous material flow. Existing operations are periodically evaluated and
monitored for effectiveness.
35.19 Contingency plans are made to satisfy customer requirements in the event of an emergency
such as utility interruptions, labor shortages, key equipment failure, and field returns. The
contingency plan is available on the Avnet Intranet website.
Work Environment (TS16949 – 6.4.1; 6.4.2)
35.20 Product safety and the means to minimize potential risks to employees are addressed in the
process procedures, equipment operation procedures, safety instructions, and during the
manufacturing process design and development.
35.21 Premises are maintained in a state of order, cleanliness, and repair.
Planning of Product Realization (TS16949 – 7.1.1)
35.22 Customer requirements and references to their technical requirements are included in the
product realization planning as a component of the production documents. When required
by the customer, any requirements for advanced process planning such as failure mode
effects and analysis (FMEA), control plan generation and production part approval (PPAP)
are complied with. The output from the product realization planning is defined as
documented control plans, process and operational procedures, work instructions, and forms
as appropriate.
Business Use Only
Acceptance Criteria (TS16949 – 7.1.2)

35.23 Acceptance criteria are defined in inspection and test procedures and are approved by the
customer, if required. Any attribute data sampling uses an acceptance level of zero defects.
Confidentiality (TS16949 – 7.1.3)
35.24 The confidentiality of customer-contracted projects, projects under development and related
product information is maintained under secure conditions and is not released to any
unauthorized persons.
Change Control (TS16949 – 7.1.4)
35.25 Changes that impact product realization are controlled and reacted to, including those
changes initiated by the customer. Production changes are assessed, verified, and validated
by technical staff to ensure compliance to customer requirements. Changes are validated by
the customer before implementation using the First Article Approval System, (AFA). When
required by the customer, any additional customer specific verifications/ identification
requirements are met.
Customer-designated Special Characteristics (TS16949 – 7.2.1.1)
35.26 Any customer designated special characteristics conform to customer requirements for
designation, documentation and control when specified by the customer.
Review of Requirements Related to the Product (TS16949 – 7.2.2.1; 7.2.2.2)
35.27 Waiving of any requirements related to the product requires customer approval.
35.28 Manufacturing feasibility of the proposed products is performed during the contract review
process, including risk analysis and records maintained. This is satisfied through a first article
approval process.
Customer Communication (TS16949 – 7.2.3.1)
35.29 The ability to communicate necessary information, including data, in the customer specified
language and format such as computer-aided design data, electronic data exchange, etc. is
available when set-up with the customer and included in the customers contract.
Design and Development (TS16949 – 7.3)
Note: Product design is not performed. Design is the responsibility of the customer. The applicable
requirement relating to design in this section relate to manufacturing process design only.
Design and Development Planning (TS16949 – 7.3.1.1)
35.30 A Multi-disciplinary approach is used to prepare for production processes, including:
a) Development/finalization and monitoring of any special characteristics.
b) Development and review of FMEAs including action to reduce potential risks.
c) Development and review of Control plans.
Design and Development Inputs (TS16949 – 7.3.2.2; 7.3.2.3)
35.31 The manufacturing process design input includes reviewing, identifying, and documenting of
any program data provided by the customer, targets for productivity, process capability, and
cost, customer requirements for identification, serialization and packaging and experience
from previous developments.
35.32 If special characteristics are identified by the customer, they are included in the control plans,
comply with customer specified definitions and symbols and are identified on applicable
process control documents, FMEAs, and operator instructions. The customer's special
characteristic symbols are use, if special characteristic symbols are specified.
Business Use Only
Design and Development Outputs (TS16949 – 7.3.3.2)

35.33 The manufacturing process design output is expressed in terms that can be verified and
validated against manufacturing process design input requirements. The manufacturing
process design outputs include:
a) Specification for the process.
b) Manufacturing process flow charts/layout.
c) Manufacturing process FMEAs.
d) Control plan.
e) Work instructions.
f) Process approval acceptance criteria.
g) Results of error-proofing activities, as appropriate.
h) Methods of rapid detection and feedback of production/manufacturing process
nonconformities.
Design and Development Review (TS16949 – 7.3.4.1)
35.34 Measurements made at specified stages of any new process design and development is
defined, analyzed, and reported as an input to management review.
Design and Development Verification (TS16949 – 7.3.5)
35.35 Verification is performed to ensure that the process design and development outputs have
met the process design and development input requirements. Records of the verifications
and any actions are maintained.
Design and Development Validation (TS16949 – 7.3.6.1; 7.3.6.2; 7.3.6.3)
35.36 Validation is performed to ensure that the process is capable of meeting the requirements for
the processing of the product in the intended application or use, if provided by the customer.
Validation is performed prior to shipment, where practical. Records of the validation and any
actions are maintained.
35.37 The production process validation is performed in accordance with any customer
requirements including program timing.
35.38 When required by the customer, a prototype program and control plan is developed.
Wherever possible, the same tooling, manufacturing processes, and subcontractors, if used,
are used for the prototype program as used in production. All performance testing activities
are monitored for timely completion and for conformance to requirements. If any services
are outsourced, full responsibility is taken by the company, including technical direction.
35.39 Product Approval Process (PPAP) has been implemented and conforms to the customer's
product and process approval procedure, when requested. The product and manufacturing
process approval procedure is applied to suppliers as requested by the customer.
Purchasing Process (TS16949 – 7.4.1.1; 7.4.1.2; 7.4.1.3)
35.40 All products and materials used in the process satisfy applicable regulatory requirements.
35.41 Sub-contracted processes that affect quality are performed by sub-contractors that are
registered to ISO 9001:2008 by an accredited third party certification body, unless otherwise
specified by the customer. Supplier quality management system development is performed
with suppliers with the goal of supplier compliance to ISO/TS16949.
35.42 When specified by the contract, products, materials, and services are purchased from
customer approved sources. The quality of the purchased products is ensured even though
customer-designated sources are specified.
Business Use Only
Verification of Purchased Product (TS16949 – 7.4.3.1; 7.4.3.2)

35.43 In order to ensure the quality of purchased product, the incoming product is verified by one
or more of the following methods:
a) Receipt of statistical data from the supplier.
b) Receiving inspection and/or testing such as sampling based on performance.
c) Second or third party assessments or audits of supplier sites, when coupled with
records of acceptable quality performance.
d) Evaluation by a designated laboratory.
e) Another method agreed by the customer.
35.44 Suppliers are encouraged to monitor their manufacturing processes. Supplier performance
is monitored through the following indicators on product received from the supplier:
a) Delivered part quality performance.
b) Customer disruptions including field returns.
c) Delivery schedule performance, including incidents of premium freight.
d) Special status customer notifications related to quality or delivery issues.
Control Plan (TS16949 – 7.5.1.1)
35.45 Control plans for the programming and packaging processes that take into account the
manufacturing process FMEA outputs have been developed. Control plans are reviewed
and updated as necessary, when changes occur which affect product, manufacturing
process, measurement, logistics, supply sources, and/or, FMEA. The control plans take into
consideration the following:
a) Controls used for the processes.
b) Methods for monitoring and control exercised over special characteristics, as
applicable.
c) Any customer required information.
d) Initiating the specified reaction plan when the process becomes unstable or not
statistically capable.
Work Instructions (TS16949 – 7.5.1.2)
35.46 Work instructions have been documented and are available at the work station for all
employees having responsibilities for the operation of processes. The work instructions are
derived from sources such as the quality plan, control plan, and the production processes.
Verification of Job Set-ups (TS16949 – 7.5.1.3)
35.47 Job set-ups are verified such as the initial run of a job, material changeover, or job change.
Work instructions are available for set-up personnel. Statistical methods of set-up
verification are used, where applicable.
Preventive and Predictive Maintenance (TS16949 – 7.5.1.4)
35.48 Machine/equipment maintenance is provided for key process equipment through the use of a
preventive maintenance system. Records of maintenance are maintained and evaluated for
the purpose of improving maintenance objectives. Predictive maintenance methods are
used to continually improve the effectiveness and efficiency of the process equipment. The
preventive maintenance system includes the following:
a) Planned maintenance activities.
b) Preservation of equipment, tooling, and gauging.
Business Use Only
c) Availability of replacement parts for key manufacturing equipment.

Management of Production Tooling (TS16949 – 7.5.1.5)
35.49 Resources have been identified for the design, fabrication, and verification of any necessary
tooling; including the outsourcing of these activities. The production tooling management
system includes:
a) Maintenance and repair facilities and personnel.
b) Tool storage and identification to define the status of tooling.
Production Scheduling (TS16949 – 7.5.1.6)
35.50 Production scheduling is customer order driven. A computerized information system
provides access to production information at key stages in the process.
Feedback of Information from Service (TS16949 – 7.5.1.7)
35.51 Any notifications from the customer of nonconformances that occur externally are recorded
and reviewed for any necessary corrective actions in the production process.
Service Agreement with Customer (TS16949 – 7.5.1.8)
35.52 Service agreements are not entered into with customers.
Validation of Processes for Production (TS16949 – 7.5.2.1)

35.53 All production processes are validated internally and as requested by the customer.
Identification and Traceability (TS16949 – 7.5.3.1)
35.54 The identification of parts is maintained throughout all stages of production by the use of
related paperwork and/or marking on the part.
Customer-owned Production Tooling (TS16949 – 7.5.4.1)
35.55 Any customer-owned tools, manufacturing, test, inspection, tooling, and equipment are
permanently marked so that ownership of each item is visible, and can be determined.\
Storage and Inventory (TS16949 – 7.5.5.1)
35.56 The condition of stock is assessed at appropriate planned intervals to detect deterioration. A
first-in-first-out (FIFO) system is used to assure stock rotation.
Measurement System Analysis (TS16949 – 7.6.1)
35.57 Statistical studies are conducted to analyze the variation present in each type of measuring
and test equipment system referenced in the control plan. The analytical methods and
acceptance criteria used, conforms to customer requirements, e.g. reference manuals on
measurement systems analysis.
Calibration/Verification Records (TS16949 – 7.6.2)
35.58 Records of calibration for all gauges, measuring and test equipment are maintained and
includes any employee and customer owned gauges.
35.59 Calibration records include:
a) Equipment identification, including the measurement standard against which the
equipment is calibrated;
b) Revisions following engineering changes to product specific gauging as
applicable;
c) Any out-of-specification readings as received for calibration;
Business Use Only
d) An assessment of the impact of the out-of-specification condition;

e) A statement of conformance to specification after calibration;
f) The notification to the customer if suspect product has been shipped to the
customer.
Laboratory Requirements (TS16949 – 7.6.3.1; 7.6.3.2)
35.60 The internal laboratory has a defined scope that includes its capability to perform the
required inspection and testing. The laboratory controls include the following:
a) Laboratory procedures for inspection and test;
b) Suitable qualifications of the Technicians;
c) Capability to perform testing correctly, with traceable to the relevant process
standard;
d) Reviews of the related quality records.
35.61 External laboratories used for inspection/test or calibrations have a defined scope that
includes the capability to perform the required service and are accredited to ISO/IEC 17025
or a national equivalent; or the laboratory is acceptable to the customer.
Measurement, Analysis, and Improvement-General (TS16949 – 8.1.1; 8.1.2)
35.62 Appropriate statistical tools are determined during advanced quality planning and included in
the control plan.
35.63 A basic knowledge of statistical concepts such as variation, control, (stability), process
capability and over adjustment are understood and utilized.
Customer Satisfaction (TS16949 – 8.2.1.1)
35.64 Customer satisfaction is monitored through continual evaluation of the performance of the
value-add processes. The performance indicators include:
a) Delivered part quality performance.
b) Customer disruptions, including field returns if notified by the customer.
c) Delivery schedule performance including incidences of premium freight.
d) Customer notifications related to quality or delivery issues.
Internal Audit (TS16949 – 8.2.2.1; 8.2.2.2; 8.2.2.3; 8.2.2.4; 8.2.2.5)
35.65 Audits of the quality management system are used to verify compliance to ISO/TS16949; as
well as, any other quality management system requirements.
35.66 The manufacturing processes are audited to determine effectiveness of the processes.
35.67 Product audits are performed at appropriate stages of production and shipping to verify
conformance to specified requirements, at a defined frequency.
35.68 Internal audits cover all quality management related processes, activities, and shifts. Audits
are scheduled according to an annual plan. The frequency of audits will be increased if
internal/external non-conformities or customer complaints occur.
35.69 Internal auditors are trained to audit to the requirements of ISO/TS16949.
Business Use Only
Monitoring and Measurement of Manufacturing Processes (TS16949 – 8.2.3.1)

35.70 The monitoring of the Quality System processes is achieved by internal audit results,
nonconformance reports and management reviews. When areas of concern are identified,
corrective action to ensure conformity of product is initiated. Process performance studies
are conducted on all new manufacturing processes to verify process capability and to
provide any additional input for process control. The results of the process studies are
documented as appropriate in production instructions, measurement and test instructions,
and maintenance instructions. These documents include objectives for manufacturing
process capability, reliability of the process, and maintainability of the process, as
appropriate. Manufacturing process capability, or performance, is maintained as specified by
the customer part approval process requirements. The control plan and process flow
diagram requirements are implemented, including:
a) Measurement techniques.
b) Sampling plans.
c) Acceptance criteria.
d) Reaction plans when the acceptance criteria are not met. Significant events
such as equipment repair are noted on the production control documents. A
reaction plan is initiated if product characteristics become either unstable or non-
capable. The reaction plans include containment of product and 100%
inspection as appropriate. Corrective action plans indicate specific timing and
assigned responsibilities to assure the process becomes stable and capable.
Reaction plans are reviewed with and approved by the customer, as required.
Records are maintained of the effective dates of any process changes.
Monitoring and Measurement of Product (TS16949 – 8.2.4.1; 8.2.4.2)
35.71 Layout inspections and functional verifications are performed to applicable customer
performance standards at sufficiently frequent intervals as specified in the control plan. The
results are available for customer review.
35.72 Appearance items requirements are not applicable to the products supplied.
Control of Nonconforming Product (TS16949 – 8.3.1; 8.3.2; 8.3.3; 8.3.4)
35.73 Unidentified or suspect product is classified as nonconforming product.
35.74 Instructions for rework, including re-inspection are accessible to and utilized by the
appropriate personnel.
35.75 Customers are promptly informed in the event that nonconforming or suspect product is
shipped.
35.76 A waiver or deviation is obtained from the customer prior to further processing whenever the
product or process is different from that currently approved. Records are maintained of the
expiration date or quantity authorized. Compliance to the original or superseding
specifications is ensured when the authorization expires. Product shipped on a waiver or
deviation is identified on each shipping container as required by the customer. The waiver
authorization system applies equally to purchased product. Requests from suppliers for a
waiver are agreed to before submission to the customer.
Business Use Only
Analysis and Use of Data (TS16949 – 8.4.1)

35.77 Trends in quality and operational performance are compared with progress toward objectives
and lead to action to support the following:
a) Development of priorities for prompt solutions to customer-related problems.
b) Determination of key customer-related trends and correlation to support status
review, decision-making, and longer term planning.
c) An information system for the timely reporting of product information arising from
usage.
Continual Improvement (TS16949 – 8.5.1.1; 8.5.1.2)
35.78 A process for continual improvement of the organization has been defined.
35.79 Continual improvement focuses on control and reduction of variation in the production
process parameters.
Corrective Action (TS16949 – 8.5.2.1; 8.5.2.2; 8.5.2.3; 8.5.2.4)
35.80 A defined process for problem solving leading to root cause identification and elimination has
been determined and documented. A customer-prescribed problem solving format is utilized
when requested by the customer.
35.81 Error proofing methods are included in the corrective action process.
35.82 Corrective actions are applied to similar process and products to eliminate the cause of
nonconformities.
35.83 Parts rejected by the customer are analyzed in a timely manner with the perspective of
initiating corrective action to prevent recurrence. Records of the analysis are kept and made
available to the customer upon request.
Business Use Only
Appendix I Rev. AD
ISO 9001 Registered Facilities
Location Scope File # Location Clauses Not Applicable Activities

Head Office Support functions for all
Avnet EM Americas locations. Top Corr Action; Cust
Management, Document Control, Satisfaction; Doc Ctrl;
60 South McKemy Ave. 7.2, Customer Related Processes and 7.4.1 & 7.4.2
Corrective Action center, Supplier 026620 HR; Internal Audit; Top
Chandler, AZ 85226 of Purchasing are not performed at this location.
Quality, Customer Satisfaction, Internal Mgmt; Quality; Supplier
Audits, Purchasing,, and Management Quality
Review Responsibilities.
The Distribution of Military/
Commercial Semiconductors/ IC’s,
60 South McKemy Ave. Established Reliability/ Commercial 7.2, Customer Related Processes and 7.4.1 & 7.4.2 Programming; HR;
026620
Chandler, AZ 85226 Passive Components, Connector of Purchasing are not performed at this location. Quality; Distribution
Products Military/ Commercial/Value
Add, and Programming/ Modification.
Av Iteso 8900 Edif 1 B
Parque Industrial Programming and distribution of 7.4.1 & 7.4.2 of Purchasing is not performed at this Programming;
013722*
Tecnologics Tlaquepaque, Integrated Circuits location. Distribution
Jalisco Mexico 45080
2110 Zanker Road Programming and distribution of 7.2, Customer Related Processes and 7.4.1 & 7.4.2 Programming;
013147*
San Jose, CA 95131 Integrated Circuits of Purchasing are not performed at this location. Distribution
Post manufacturing services to
semiconductor devices including
26 Clinton Drive customer specified programming,
1621316* None Programming
Hollis, NH 03049 testing, tape and reeling, material
procurement and management and
engineering analysis test services.
Distribution of XYZ Products, Military Sales; Purchasing (IP&E
400 Franklin Rd, Ste 260 7.5.4, Customer Property is not handled at this
Packaging, sales, Marketing, and 005485* & XYZ Only); Quality;
Marietta, GA 30067 location.
Purchasing. Distribution
6700 W Morelos Place Distribution of Computer Components 7.2, Customer Related Processes and 7.4.1 & 7.4.2
1058174* Distribution; Quality
Chandler, AZ 85226 for the computer technology sector. of Purchasing are not performed at this location.
Calzada Industrial Nuevo
Quality; Cable Assy;
Nogales #1061,
Connector Assy; Doc
Fraccionamiento: Parque The assembly of electronic connectors, 7.2, Customer Related Processes is not performed
1609379* Ctrl; Quote Center;
Industrial Nuevo Nogales, cables, and wiring harnesses. at this location.
Purchasing;
Nogales, Sonora, MX C.P.
Distribution; Integration
84094
Engineering; HR;
Custom configuration, integration, and Integration; Quality;
6700 W Morelos Place 5.2, Customer Focus and 7.4.1 & 7.4.2 of Purchasing
distribution of computer products for 1611724* Top Mgmt; Doc Ctrl;
Chandler, AZ 85226 are not performed at this location.
the computer technology sector. Supplier Quality; Corr
Action; Internal Audit
5.3, Quality Policy; 5.4, Planning; 5.6, management
Sales; Configuration
Custom configuration, integration, and Review; 7.1, Planning of Product Realization; 7.5,
8700 South Price Rd Mgmt; Purchasing;
distribution of computer products for 1611728* Production and Service provision; 7.6, Control of
Tempe, AZ 85284 Quote Center; Cust
the computer technology sector. Monitoring and Measuring Equipment; 8.2,
Satisfaction; HR
Monitoring & Measurement
Custom configuration, integration, and Sales; Configuration
19031 Ridgewood Parkway 5.3, Quality Policy; 5.4, Planning; 5.6, Management
distribution of computer products for 1611730* Mgmt; HR; Purchasing;
San Antonio, TX 78259 Review; 7.1 Planning of Product Realization
the computer technology sector. Quote Center
Engineering;
Custom configuration, integration, and 5.3, Quality Policy; 5.6, Management Review; 7.2,
8 Craig Road Integration; Quality;
distribution of computer products for 1611729* Sales, and 7.4.1 & 7.4.2 of Purchasing are not
Acton, MA 01720 Distribution; Internal
the computer technology sector. performed at this location.
Audit
Custom configuration, integration, and 5.3, Quality Policy; 5.6, Management Review; 7.2, Engineering; Quality;
326 Charcot Avenue
distribution of computer products for 1622180* Sales; 7.4.1 & 7.4.2 of Purchasing are not Integration;
San Jose, CA 95131
the computer technology sector. performed at this location. Configuration Mgmt
2100 NW 97th Ave. #101 The Distribution and Integration of 7.2, Customer Related Processes and 7.4.1 & 7.4.2
1621316* Distribution; Quality
Miami, FL 33172 Computer Products of Purchasing are not performed at this location.
Custom configuration, integration, and
2110 Zanker Road
distribution of computer products for 1622181* 7.2, Customer Related Processes and 7.4.1 & 7.4.2 Distribution; Quality
San Jose, CA 95131
the computer technology sector. of Purchasing are not performed at this location.
*Site may be dependent on activities performed at site with file #026620.
Business Use Only
Appendix I Rev. AD
AS9100 Registered Facilities

7.1.f, Identification of resources to support the use
and maintenance of product is not applicable to
60 South McKemy Ave. Established Reliability/ Commercial Programming; HR;
026620 distribution ; 7.2, Customer Related Processes and
Chandler, AZ 85226 Passive Components, Connector Quality; Distribution;
7.4.1 & 7.4.2 of Purchasing are not performed at
this location.
Calzada Industrial Nuevo and maintenance of product is not applicable to
Nogales #1061, distribution ; 7.2, Customer Related Processes and Quality; Cable Assy;
The assembly of electronic connectors,
Fraccionamiento: Parque 1609379* 7.4.1 & 7.4.2 of Purchasing are not performed at Connector Assy; Doc
cables, and wiring harnesses.
Industrial Nuevo Nogales, this location.7.5.1.1, Production Process Ctrl; Distribution
Nogales, Sonora, MX C.P. Verification is not applicable to Connector
84094 Assembly.
*Site may be dependent on activities performed at site with file #026620.
Location Scope File #

60 South McKemy Ave. Established Reliability/ Commercial
026620
Chandler, AZ 85226 Passive Components, Connector
The distribution of computer
components, and networking
equipment, customer configuration,
6700 W Morelos Place
integration and services for OEM's to 1058174
Chandler, AZ 85226
support value added resellers and end-
user markets in the computer
technology sector.
Calzada Industrial Nuevo
Nogales #1061,
Fraccionamiento: Parque Assembly of electronic connectors,
1609379
Industrial Nuevo Nogales, cables, and wiring harnesses.
Nogales, Sonora, MX C.P.
84094

Engineering; HR;
Integration; Quality;
6700 W Morelos Place Contract manufacturer of computer 5.2, Customer Focus and 7.4.1 & 7.4.2 of Purchasing Top Mgmt; Doc Ctrl;
1611724
Chandler, AZ 85226 systems used in medical devices. are not performed at this location. Supplier Quality; Corr
Action; Internal Audit;
Servicing
Calzada Industrial Nuevo and maintenance of product is not applicable to
Quality; Cable Assy;
Nogales #1061, distribution ; 7.2, Customer Related Processes is not
The assembly of electronic connectors, Connector Assy; Doc
Fraccionamiento: Parque 1609379 performed at this location except quotes for
cables, and wiring harnesses. Ctrl; Integration; Quote
Industrial Nuevo Nogales, Subcontracted Value Add work is performed;
Center; Purchasing
Nogales, Sonora, MX C.P. 7.5.1.1, Production Process Verification is not
84094 applicable to Connector Assembly.
Business Use Only
Appendix II Rev. N
Avnet, Inc.
President/CEO
Avnet, Inc.
V. P. Customer
President EM CIO President ATS
Engagement
Avnet, Inc
Customer Loyalty
Chief Global
President EM President ATS
Logistics &
Americas Americas
Operations Officer
Group Sr VP-Dir
Exec Sales-
Sales & Marketing Americas Sales & Marketing
Operations Operations
Materials Defense/Aero Materials
Purchasing Electro-Air Marietta, GA Purchasing
Sr. V. P. Logistics
and Warehousing V. P. Global Traffic Sr. V. P. V. P. Global
Americas & Global & Transportation Programming Quality
Quality
Connector, Cable VAD Integration Programming Centers Quality Assurance

Nogales, MX Chandler, AZ Morelos Chandler, AZ McKemy
Logistic Centers Acton, MA Hollis, NH
Chandler, AZ McKemy San Antonio, TX San Jose, CA
Chandler, AZ Morelos San Jose, CA Guadalajara, MX
Miami, FL
San Jose, CA
Business Use Only
Appendix III Rev. D
PROCESSES - ISO 9001 & ISO 14001

INPUT TRANSFORMATION OUTPUT
CUSTOMER SALES CORRECTIVE HANDLING & SHIP TO

DIRECT SHIP
REQUIREMENTS REVIEW ACTION DELIVERY CUSTOMER
SUPPORT FUNCTIONS
VALUE ADD
DOCUMENT CONTROL
CALIBRATION NONCONFORMIN
PREVENTIVE ACTION G PRODUCT
CONNECTOR QUALITY RECORDS
ASSEMBLY INTERNAL QUALITY AUDITS
STATISTICAL TECHNIQUES
QUALITY SYSTEM
MANAGEMENT RESPONSIBILITY INSPECTION
CABLE
INFORMATION SERVICES
ASSEMBLY & TEST
STATUS
INTEGRATION
INSPECTION
AND TESTING
PURCHASING
PROGRAMMING
CUSTOMER
SUPPLIED PROCESS
PRODUCT CONTROL
PRODUCT ID
AND
TRACEABILITY
CUSTOMER CORRECTIVE
RMA'S
SATISFACTION ACTION
Business Use Only
Appendix IV Rev. J
QMS/EMS Procedures
QMS Requirement Manual Tier II Procedure
Contract Review QM0492 02-CON-01
Document Control QM0492 02-DOC-01
Purchasing QM0492 02-PUR-01
Customer Supplied Product QM0492 02-PSP-01
Product ID & Traceability QM0492 02-TRA-01
Process Control QM0492 Site Work Instructions
Inspection & Testing QM0492 02-INT-01
Calibration QM0492 02-CAL-01
Records QM0492 02-RCD-01
Internal Audits QM0492 02-AUD-01
Handling, Storage, Packaging, Preservation, and Delivery QM0492 02-HST-01
Nonconforming Product QM0492 02-NCM-01
Corrective & Preventive Action QM0492 02-CAR-01
Statistical Techniques QM0492 02-SPC-01
Training QM0492 02-TRN-01
Environmental Management QM0492 02-ENV-01
Business Use Only
Appendix V Rev. B
Business Use Only
Appendix V Rev. B
Customer Fulfillment Process
Contract
RFQ
review
Schedule/
Planning
Set up
Programming
Labeling
Marking
Verification
First Article Tape & Reel
PPAP Purchasing
APQP Verification
Store Ship
FEMA Lead Scan (As
applicable)
Baking (As
applicable)
Package/Label
Packaging
Receiving
Business Use Only
Appendix VI Rev. B
AS9100 Cross Reference Document
QMS Requirement AS9100 Clauses Document
Quality System 4.1; 4.2; 4.2.1; 4.2.2 QM0492
Document Control 4.2.3 02-DOC-01
Records 4.2.4 02-RCD-01
Configuration Management 4.3 02-CFG-01
Training 6.2.2 02-TRN-01
Contract Review 7.1; 7.2 02-CON-01
Purchasing 7.4 02-PUR-01
Process Control 6.3; 6.4; 7.5.1 Site Work Instructions
Identification & Traceability 7.5.3 02-TRA-01
Customer Supplied Product 7.5.4 02-PSP-01
Handling, Storage, Packaging, Preservation, and Delivery 7.5.1; 7.5.5 02-HST-01
Calibration 7.6 02-CAL-01
Statistical Techniques 8.0 02-SPC-01
Inspection & Testing 7.1; 7.4; 8.2.4 02-INT-01
Customer Satisfaction 8.2.1 QM0492
Audits 8.2.2 02-AUD-01
Nonconforming Product 8.3 02-NCM-01
Corrective & Preventive Action/Continual Improvement 8.5.1; 8.5.2 02-CAR-01
Business Use Only
Appendix VII Rev. A
Logistics QMS Processes – AS9100
Leadership and Direction
• Business Planning
Top Management • Management Review
Top Management
Document Control
(Chandler) Internal System
Measurement, Analysis, Improvement
Audits
Resource Management (Chandler)
• Customer Satisfaction (On-Line Website)
Customer Requirements
Customer Satisfaction
• Training • Informal Customer Complaints (Sales Branch)
• Maintenance • Corrective Action (Chandler)
• Fixture Control • Nonconforming Material
• Calibration • Preventive action
• Returned Material Analysis
Customer Fulfillment
(See Flow Diagram)
•Scheduling/Planning • Labeling
• Logistics • Marking Subcontracted Processes
• Design • Verification (As applicable)
• Purchasing • Storage
RFQ • Receiving • Packaging
(Sales Branches) Completed Shipments
Product Design • Put Away Inventory • Shipping
(Customer) Contract Review • Pick Process
(Sales Branches) • Pack Process
• Ship Process
Input Output
Business Use Only
Appendix VII Rev. A

RFQ Contract
review
Schedule/Pla
nning Order download to
RF. Operator
picks per
instructions.
Product is
packaged to Ship
specification.
Purchasing
Order is inspected
as required, and
processed to ship
area.
Receiving
Order
Processed
Business Use Only
Appendix VIII Rev. A
Value-Add Assembly QMS Processes – AS9100
Leadership and Direction
Top Management • Business Planning Top Management

• Management Review
Document Control
Internal System
(Chandler) Measurement, Analysis, Improvement
Audits
Resource Management (Chandler)
• Customer Satisfaction (On-Line Website)
Customer Requirements
Customer Satisfaction
• Training • Informal Customer Complaints (Sales Branch)
• Maintenance • Corrective Action (Chandler)
• Materials • Nonconforming Material
• Calibration • Preventive Action
• Returned Material Analysis
Customer Fulfillment
(See Flow Diagram)
•Customer Design • First Piece Build

• Review • 1st Article (As
• Scheduling/Planning Applicable)
• Assembly Process • Assembly (Production)
RFQ • Design • Marking
Product Design (Sales Branches) Finished Goods
• Purchasing • labeling
(Customer) Contract Review Connectors/Cables
• Receiving • First assembly Insp.
(Sales Branches) • Kitting • Out Gassing (As
• First Article (As Applicable) Applicable)
• Packaging
Input Output
• Storage (Build to Stock
Only)
• Shipping
Business Use Only
Appendix VIII Rev. A

RFQ Contract
Review
Schedule/ • 1st Piece Build

Planning (Cable)
•1st Article (As
Applicable)
•Assembly
•Marking
•Labeling
Purchasing •Final Inspection
First Article •Degas/Out Gas Ship
(As Applicable) (As Applicable)
•Storage (build
to Stock Only)
•Documentation
(Certificates as
Applicable) Store
Receiving •Packaging Build-to-
Stock Items
Business Use Only
Appendix IX Rev. A
Business Use Only
Appendix IX Rev. A
Contract
RFQ
Review
Schedule/
Planning
Set up
Programming
Labeling
Marking
Verification
Tape & Reel
First Article Purchasing Verification
Lead Scan (As
Store Ship
applicable)
Baking (As
applicable)
Package/Label
Packaging
Receiving
Business Use Only
Appendix X Rev. C
EMS Elements Interaction & Related Documents
Continual Improvement
•02-CAR-01
Environmental Policy
•QM0492
Management Review
• QM0492
Planning
•02-ENV-01 QM0492
Checking
• 02-NCM-01 02-CAL-01 02-AUD-01

• 02-CAR-01 02-RCD-01 QM0492
Implementation and Operation
•02-DOC-01 02-TRN-01 02-ENV-01

•QM0492
Business Use Only
Appendix XI Rev. B
ATS Business Process Documents
Document Number Title

KP03-0002 ATS Business System Overview
KP01-0001 TS Strategic Planning Process

KP06-0004 Control of Records
KP06-0001 Control of Documents

KP02-0001 Business Management System Review
KP05-0001 Training & Development
WI02-0025 ESD Procedure
KP08-0004 Technical Operations Prototype Process

KP08-0003 Product Change Request - ECN
KP08-0002 First Article & Validate

KP10-0001 Embedded Solutions Order Schedule
KP09-0001 Supplier Onboarding Process

KP08-0001 Requirements Development
KP08-0005 AGSC Solutions Desk – Quote Process

KP13-0003 Control of Nonconforming Product
KP10-0004 Product Integration & Final
KP04-0001 Equipment Calibration & Maintenance
WI02-0006 Quality Bulletin
KP12-0001 Internal Audit
KP14-0002 Corrective & Preventive Action

KP13-0001 Failure Evaluation
KP13-0002 Problem Solving

KP03-0001 ATS Business Quality Manual (URL’s)
KP14-0001 Continual Improvement
KP06-0003 Data Control & Maintenance
KP07-0001 AES Account Management

KP07-0004 Genesis Order Flow Through Credit
KP09-0004 Inventory Management

KP09-0002 Material Procurement
Business Use Only

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Quality Manual QM0492 Rev.

Table of Content (Continued)

3.3 ISO 13485

4.4 ISO 14001:2004 Environmental Management Systems – Requirements with

4.5 ISO 13485:2003 Medical Devices – Quality management systems - Requirements

5.0 Management Responsibility

7.0 Management Representative

13.0 Customer Requirements

17.3 When it has been determined to verify purchased product/services at the

25.0 Handling, Storage, Preservation, Packaging, and Delivery

33.0 Supplemental Requirements for AS9100 Registered Facilities

Planning of Product Realization (AS9100 – 7.1)

Purchasing Process (AS9100 – 7.4.1)

Control of Production and Service Provision (AS9100 – 7.5.1)

Preservation of Product (AS9100 – 7.5.5)

34.0 Supplemental Requirements for ISO 13485 Registered Facilities

Quality Management System Requirements (ISO 13485 – 4.1)

Work Environment (ISO 13485 – 6.4)

Corrective Action (ISO 13485 – 8.5.2)

35.0 Supplemental Requirements for TS16949 Registered Facilities

Acceptance Criteria (TS16949 – 7.1.2)

Design and Development Outputs (TS16949 – 7.3.3.2)

Verification of Purchased Product (TS16949 – 7.4.3.1; 7.4.3.2)

c) Availability of replacement parts for key manufacturing equipment.

Validation of Processes for Production (TS16949 – 7.5.2.1)

d) An assessment of the impact of the out-of-specification condition;

Monitoring and Measurement of Manufacturing Processes (TS16949 – 8.2.3.1)

Analysis and Use of Data (TS16949 – 8.4.1)

ISO 9001 Registered Facilities

Location Scope File # Location Clauses Not Applicable Activities

AS9100 Registered Facilities

Location Scope File # Location Clauses Not Applicable Activities

ISO 14001 Registered Facilities

Location Scope File #

ISO 13485 Registered Facilities

Location Scope File # Location Clauses Not Applicable Activities

Connector, Cable VAD Integration Programming Centers Quality Assurance

PROCESSES - ISO 9001 & ISO 14001

CUSTOMER SALES CORRECTIVE HANDLING & SHIP TO

QMS Requirement Manual Tier II Procedure

Contract Review QM0492 02-CON-01

Document Control QM0492 02-DOC-01

Purchasing QM0492 02-PUR-01

Customer Supplied Product QM0492 02-PSP-01

Product ID & Traceability QM0492 02-TRA-01

Process Control QM0492 Site Work Instructions

Inspection & Testing QM0492 02-INT-01

Calibration QM0492 02-CAL-01

Records QM0492 02-RCD-01

Internal Audits QM0492 02-AUD-01

Handling, Storage, Packaging, Preservation, and Delivery QM0492 02-HST-01

Nonconforming Product QM0492 02-NCM-01

Corrective & Preventive Action QM0492 02-CAR-01

Statistical Techniques QM0492 02-SPC-01

Training QM0492 02-TRN-01

Environmental Management QM0492 02-ENV-01

Customer Fulfillment Process

AS9100 Cross Reference Document

QMS Requirement AS9100 Clauses Document