Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                

Quality Manual: Tech Circuits, Inc

Download as pdf or txt
Download as pdf or txt
You are on page 1of 25

Tech Circuits, Inc.

____________________________________

QUALITY
MANUAL
Revision D

ISO 9001:2000

__________________________________________________________________
Approved By:
__________________________________________________________________

______________________________________________ 04/04/2008
President (Owner) Date

______________________________________________ 04/04/2008
Vice President (Owner) Date

______________________ 04/04/2008
ISO 9001:2000 Management Rep. Date
Tech Circuits, Inc. ISO 9001:2000 Quality Manual

Revision Table

Rev. Date Review/Revision Description

A 10/01/02 Initial Release

Made all recommended changes per


B 11/10/03
NQA Audit 03/06492/SP01

C 10/19/07 Updated per NQA Audit #RE02/S08

Removed internal signature page (duplicate information)


D 04/04/08
per NQA Audit 03/26/08 #S09

Last Update: 04-APR-08 Quality Manual Rev D Page 2 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

Table of Contents

I. Introduction .............................................................................................................................. 4

II. Quality Policy ....................................................................................................................... 5

III. Organizational Flow Chart.................................................................................................... 6

IV. Manufacturing Plan Flow Chart............................................................................................ 7

V. Scope..................................................................................................................................... 8

VI. Responsibility and Authority ................................................................................................ 9

VII. Procedure Matrix .............................................................................................................. 12

VIII. Procedures......................................................................................................................... 14
4.0 QUALITY MANAGEMENT SYSTEM ................................................................................................................14
4.1 General Requirements .............................................................................................................................14
4.2 Documentation Requirements..................................................................................................................14
5.0 MANAGEMENT RESPONSIBILITY ...................................................................................................................16
5.1 Management Commitment .......................................................................................................................16
5.2 Customer Focus .......................................................................................................................................16
5.3 Quality Policy ..........................................................................................................................................16
5.4 Planning...................................................................................................................................................16
5.5 Responsibility, Authority and Communication ........................................................................................17
5.6 Management Review ................................................................................................................................17
6.0 RESOURCE MANAGEMENT............................................................................................................................18
6.1 Provision of Resources ............................................................................................................................18
6.2 Human Resources ....................................................................................................................................18
6.3 Infrastructure...........................................................................................................................................18
6.4 Work Environment ...................................................................................................................................18
7.0 PRODUCT REALIZATION ...............................................................................................................................19
7.2 Customer-Related Processes ...................................................................................................................19
7.3 Design and Development .........................................................................................................................20
7.4 Purchasing...............................................................................................................................................20
7.5 Production and Service Provision ...........................................................................................................21
7.6 Control of Monitoring and Measuring Devices .......................................................................................22
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT ..........................................................................................23
8.1 General ....................................................................................................................................................23
8.2 Monitoring and Measurement .................................................................................................................23
8.3 Control of Non-conforming Product........................................................................................................24
8.4 Analysis of Data.......................................................................................................................................24
8.5 Improvement ............................................................................................................................................25

Last Update: 04-APR-08 Quality Manual Rev D Page 3 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

I. Introduction
This Quality Manual describes the policies and company wide control system of Tech Circuits, Inc., Company
Quality Management System (QMS). This Quality Management System addresses the requirements of the ISO
(International Organization for Standardization) Quality Standards as defined in ISO 9001:2000. The Quality
Procedures and Work Instructions of the Tech Circuits, Inc. are proprietary. All unauthorized use is prohibited.
Tech Circuits is a full-service, totally integrated manufacturer of Printed Circuit Boards, which was founded in 1979
by Philip Walton and Gregory Peterson. Tech Circuits has a single manufacturing facility, located at 340
Quinnipiac St. in Wallingford, Connecticut.
Tech Circuits products range from low technology single and double-sided printed circuits to extremely aggressive
multilayer boards using 3 mil line/space technology, impedance control, and/or exotic materials.

Approval
This quality manual has been approved in its entirety prior to issue by the executive management, signatures
of which are listed below the Quality Policy (Ref. Sec. II). One or more of the same functions shall approve
all subsequent revisions. Tech Circuits, Inc. reserves the right to make improvements of the quality
procedures and work instructions without necessarily revising the quality manual. This manual will receive a
general review on an annual basis, and will be revised as needed.
The participation of all Tech Circuits, Inc. employees in the development and approval of quality procedures
and work instructions is encouraged.

Last Update: 04-APR-08 Quality Manual Rev D Page 4 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

II. Quality Policy

“Tech Circuits, Inc. is committed to


continuous improvement
in both quality and productivity.

Our Top Management utilizes quarterly meetings to


establish, review and communicate our company’s
quality system and objectives.

Together, we strive to anticipate and fulfill the


needs of our customers by manufacturing quality products
that consistently meet or exceed requirements for
performance and reliability.

Superior quality and on-time delivery is


our primary goal.”

Management ensures that the Quality Policy is understood, implemented and maintained at all
levels of the company and is conformant to the ISO 9001:2000 International Standard. This is
accomplished by:

1. The proper induction of all personnel to the Quality System.


2. The display of the Quality Policy at prominent locations.
3. Scheduled audits and reviews of Quality Procedures to verify
implementation and effectiveness and suitability.
4. Specific and measurable goals are also set and reviewed as part of
management meetings.

__________________________________________ 05/30/2003
President (Owner) Date

___________________________________________ 05/30/2003
Vice President (Owner) Date

Last Update: 04-APR-08 Quality Manual Rev D Page 5 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

III. Organizational Flow Chart

President / Co-Owner Exec. Vice President / Co-Owner


(Production Manager) (Sales Manager)

Management Rep. Sales Department

Q.C. Manager Controller / Human


Resources

Drill / Fab Manager Imaging Manager

Soldermask Manager Engineering Manager

Plating Manager Multi-layer Manager

Purchasing Manager Maintenance Rep

Last Update: 04-APR-08 Quality Manual Rev D Page 6 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

IV. Manufacturing Plan Flow Chart

Multilayer Process Only

Kit Layer Coat, Inspect Layer Etch Oxide


Core Expose & & Strip Cu Mat’l &
Panels Develop Bake

AOI
Multilayer
DT Mat’l
AOI

Sales /
Contract Review Engineering Trim Laminate
Process Films & &
Definition Tack Measure
Communication
Center
Double Sided

Layer Clean, Hole Clean & Shear


Coat, Expose & Metalize Drill Panels
Develop (Thruplate) (If req’d)

Inspect Pattern Strip Sn In-Process Soldermask


&Ω Plate and Strip Inspect and Legend
check Cu & Sn Etch

Pack Silver, Clean & HASL,


and E.T. & OSP, Final Rout & Ni/Au,
Ship Ω check etc. Inspect V-Score etc.

(Process Flow Chart)

Last Update: 04-APR-08 Quality Manual Rev D Page 7 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

V. Scope
This Quality Manual describes the Quality Management System used at Tech Circuits and applies to all activities
and personnel within. It best describes our efforts to attain compliance with intent of the general quality
requirements of ISO 9001:2000. The quality policy of Tech Circuits shall apply this system to supplies, materials
and services procured as well as products produced for end use by Tech Circuits’ customers.

Exclusions to the ISO 9001:2000 Standard (Ref. 1.2 Application) for Tech Circuits, Inc. include the following:
Design Requirements (Ref. 7.3) – All of Tech Circuits, Inc. product designs are created, controlled
and supplied by it’s customers although Tech Circuits, Inc. regularly offers design
recommendations to enhance manufacturability.
Service Provisions (Ref. 7.5) – Due to the nature of the products manufactured by Tech Circuits,
Inc., our customers do not require us to perform any services that would be covered by this
section.

This manual provides Tech Circuits’ personnel and customers with a general description of our Quality
Management System, which has been planned and developed to assure all products and services conform to
customer orders and contracts.

Written procedures for supplementing the system described herein shall be established and maintained.

Facility
Tech Circuits, Inc. is located on a single site in Wallingford, CT 06492 (USA)

Mailing Address
Tech Circuits, Inc.
340 Quinnipiac Street
P.O. Box 309
Wallingford, CT 06492
Tel: (203)-269-3311
Fax: (203)-284-9389

Last Update: 04-APR-08 Quality Manual Rev D Page 8 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

VI. Responsibility and Authority


General
The organizational flow chart (Ref. Sec. III) shows the interrelationship of positions and functions within
the company and the paths of responsibility and authority in relation to quality. Quality is the
responsibility of every employee of Tech Circuits Inc. The responsibility to provide leadership, training,
and education of employees is shared, but not limited to Top Management. The following have been
assigned responsibility and authority for providing and maintaining capabilities to meet product
requirements and ensuring the integrity of the Quality System (Ref. International Organization for
Standardization, ISO 9001:2000).

President and Executive Vice President


The President and Executive Vice President are the co-owners of Tech Circuits and have equal authority
within the organization. The President is also the Production Manager and oversees the day-to-day
workings of the manufacturing floor from a managerial standpoint. The Executive Vice President is also
the Sales Manager and is responsible for all sales, marketing, quoting, and the release of orders to the shop
floor. Together, they are also responsible for the appointment of all managerial positions within Tech
Circuits.

Top Management (Management Council)


The Top Management reviews commitment to development and implementation, continuous improvement,
establishing quality policy and objectives, communications to Tech Circuits employees the importance of
meeting customer satisfaction a well as statutory and regulatory requirements, and establish proper
planning to assure that changes maintain integrity.

Management Representative
The Management Representative is in charge of the ISO 9001:2000 Quality System program at Tech
Circuits, Inc. Although Tech Circuits has no Quality Assurance Manager, the title is used within our
documentation to describe the Management Representative. In addition, any references to the Quality
Assurance Department is to be interpreted as all those responsible for, and having the authority for the
coordination and administration of the ISO 9001:2000 Quality System program.

Quality Control Manager


The Quality Control Manager is responsible for the inspection and test of all products manufactured at
Tech Circuits Inc. Also for the implementation and enforcement quality standards set fourth by Tech
Circuits and all necessary industry standards and regulations (Ref. ISO 9001:2000, IPC, UL, etc).

Last Update: 04-APR-08 Quality Manual Rev D Page 9 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

Controller/Human Resources Manager


The Controller/Human Resources Manager is responsible for and has the authority over all of the day-to-
day office and financial activity, purchasing, payroll, and all Human Resource functions including
administration of insurance and benefit programs.

Engineers
Tech Circuits engineers are responsible for the creation and introduction of detailed instructions and tooling
to the production floor. They also handle customer design (Design for Manufacturability or DFM)
problems and issues, directly through the customer. They also maintain Customer specs and
documentation.

All Employees
All Tech Circuits employees strive to maintain and improve the quality of their work processes. They are
also empowered to stop the work process when it becomes apparent that the required quality is not being
achieved.

Last Update: 04-APR-08 Quality Manual Rev D Page 10 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

Top Management/Management Council of Tech Circuits, Inc.


[as appointed by Philip Walton and Gregory Peterson].

The Management Council is made up of the following members:

Official Title / Appointed Position


President / Production Manager
Vice President / Sales Manager
Management Rep. /Q.A. Manager
V. P. Sales / Marketing
Controller / Human Resources
Quality Control Manager
Purchasing Manager
Engineering Manager
Drill / Fabrication Manager
Dry Film Manager
Screening Manager
Plating Manager
Multi-layer Manager
Maintenance Representative

The employees listed above are responsible for all of the duties and conditions of Tech Circuits Quality
Manual Section 5.0 and their positions, so stated in our Training Records, are of executive appointment as
seen both necessary and appropriate by the Tech Circuits owners.

_________________________________________ 05/30/2003
President (Owner) Date

_________________________________________ 05/30/2003
Vice President (Owner) Date

Last Update: 04-APR-08 Quality Manual Rev D Page 11 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

VII. Procedure Matrix


Section Section Title Procedure No. Procedure Title
4.1 Quality Management System TCP-QM-0003 Quality System
4.2 Documentation Requirements TCP-QM-0003 Quality System
4.2.1 General Document Requirements TCP-QM-0005 Control Document Distribution
4.2.2 Quality Manual TCP-QM-0003 Quality System
TCP-QM-0005 Control Document Distribution
TCP-QM-0006 Quality Manual I,C &D
TCP-QM-0007 Procedures Manual I,C &D
4.2.3 Control of Documents
TCP-QM-0008 Work Instructions I,C&D
TCP-QM-0009 Forms & Records I,C & D
TCS Database ISO Documentation Control
TCP-QM-0020 Control of Quality Records
4.2.4 Control of Quality Records
JTS Database Customer Documentation Control
5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning TCP-QM-0001 Management Responsibility
5.5.1 Responsibility and Authority & &
5.5.2 Management Rep. TCP-QM-0002 Management Review
5.5.3 Internal communication
5.6.1 Management Review
5.6.2 Review Input
5.6.3 Review Output
6.1 Provisions of Resources TCP-QM-0003 Quality System
TCP-QM-0003 Quality System
6.2.1 Human Resources
TCP-QM-0028 Training
Competence, Awareness and
6.2.2 Competence, Awareness and Training TCP-QM-0028
Training
6.3 Infrastructure TCP-QM-0030 Process Control
TCP-QM-0015 Prevent Maintenance
6.4 Work Environment TCP-QM-0022 Department Safety
TCP-QM-0024 Plant Start up

Last Update: 04-APR-08 Quality Manual Rev D Page 12 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

Section Section Title Procedure No. Procedure Title


TCP-QM-0003 Quality System
TCP-QM-0001 Management Responsibility
TCP-QM-0002 Monthly Quality Reports
7.1 Planning of Product Realization TCP-QM-0002 Management Review
TCP-QM-0026 Work Instruction
TCP-QM-0030 Process Control
TCP-QM-0016 Inspection and Test
Determination of Requirements Related to TCP-QM-0004 Contract Review
7.2.1
the Product TCP-QM-0032 Design
Review of Requirements Related to the
7.2.2 TCP-QM-0004 Contract Review
Product
7.2.3 Customer Communication TCP-QM-0004 Contract Review
TCP-QM-0010 Purchasing
7.4.1 Purchasing Process
TCP-QM-0011 Supplier Qualifications
7.4.2 Purchasing Info TCP-QM-0010 Purchasing
TCP-QM-0010 Purchasing
7.4.3 Verification of Purchased Product
TCP-QM-0016 Inspection and Test
TCP-QM-0015 Preventive Maintenance
TCP-QM-0026 Work Inst. Development
7.5.1 Control of Production TCP-QM-0030 Process Control
TCP-QM-0016 Inspection and Test
TCP-QM-0014 Handl’g, Stg, Pkg, Perv, & Del.
7.5.2 Validation of Process for Production TCP-QM-0030 Process Control
TCP-QM-0012 Product ID and Traceability
7.5.3 Identification and Traceability TCP-QM-0016 Inspection and Test
TCP-QM-0018 Inspection and Test Status
7.5.4 Customer Property TCP-QM-0033 Control of Customer Supp. Product
7.5.5 Preservation of Product TCP-QM-0014 Handl’g, Stg, Pkg, Perv, & Del.
7.6 Control of Monitoring & Measuring Devices TCP-QM-0017 Control of Insp., Meas.& Test
TCP-QM-0016 Inspection and Test
8.1 Measurement, Analysis & Improvement TCP-QM-0021 Internal Audits
TCP-QM-0027 Statistical Techniques
TCP-QM-0002 Management Review
8.2.1 Customer Satisfaction
QAM sec 8.2.1 Customer Satisfaction
8.2.2 Internal Audits TCP-QM-0021 Internal Audits
TCP-QM-0030 Process Control
TCP-QM-0026 Work Instruction
8.2.3 Monitoring and Measurement of Process
TCP-QM-0021 Internal Audits
TCP-QM-0027 Statistical Techniques
TCP-QM-0016 Inspection and Test
8.2.4 Monitoring and Measurement of Product
TCP-QM-0027 Statistical Techniques
8.3 Control of Nonconformity TCP-QM-0019 Control of Nonconforming Product
TCP-QM-0013 Corrective and Preventive Action
TCP-QM-0019 Control of Non-conforming Product
8.4 Analysis of Data
QAM sec 8.2.1 Customer Satisfaction
TCP-QM-0027 Statistical Techniques
8.5.1 Continual Improvement QAM sec 8.5.1 Continual Improvement
8.5.2 Corrective Action TCP-QM-0013 Corrective and Preventive Action
8.5.3 Preventive Action TCP-QM-0013 Corrective and Preventive Action

Last Update: 04-APR-08 Quality Manual Rev D Page 13 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

VIII. Procedures

4.0 Quality Management System


4.1 General Requirements
Tech Circuits shall establish, document, implement, maintain and continually improve the
effectiveness of its quality management system in accordance with the requirements of the ISO
9001:2000 International Standard.
To implement the quality management system, Tech Circuits shall:
a. Identify the processes needed for the quality management system.
b. Determine the sequence and interaction of these processes.
c. Determine the criteria and methods required to ensure the effective operation and control of
these processes.
d. Ensure the availability of resources and information necessary to support the operation and
monitoring of these processes.
e. Measure, monitor and analyze these processes, and
f. Implement actions necessary to achieve planned results and continual improvement of these
processes.

Tech Circuits shall manage these processes in accordance with the requirements of the ISO 9001:2000
International Standard.
When a choice to outsource any process that affects product conformity with requirements, Tech
Circuits shall ensure control over such processes. Control of such outsourced processes shall be
identified within our Quality Management System.

4.2 Documentation Requirements


4.2.1 General Documentation Requirements
The quality management system documentation shall include:
a. A Quality Manual,
b. documented statements of a quality policy and quality objectives,
c. documented procedures required in this International Standard,
d. documents needed by Tech Circuits, Inc. to ensure the effective planning, operation and
control of its processes,
e. records required by the International Standard ISO 9001:2000. (Ref. 4.2.4).

Note 1: Where the term documented procedures appears within the ISO 9001:2000 Standard,
this requires the procedure to be established, documented, implemented and
maintained.
Note 2: The extent of the quality management system documentation at Tech Circuits, Inc.
shall be dependent on the following:
a. Size and type of our activities conducted at Tech Circuits, both present and future.
b. Complexity and interaction of the processes.
c. Competence of personnel.
Note 3: The documentation can be in any form or type of medium.

Last Update: 04-APR-08 Quality Manual Rev D Page 14 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

4.2.2 Quality Manual


Tech Circuits, Inc. will establish and maintain a quality manual that includes;
a. the scope of the Quality Management System, including details of, and justification for
any exclusions (Ref Sec. 1.2 of ISO 9001:2000)
b. the documented procedures established for the quality management system or reference
to them, and
c. a description of the interaction between the processes of the quality management system.

4.2.3 Control of Documents


Documents required by the Quality Management System will be controlled. Quality records are a
special type of document and will be controlled according to the requirements given in section
4.2.4 below.
A documented procedure will be established to define the controls needed to,
a. approve documents for adequacy prior to issue,
b. review and update as necessary and re-approve documents,
c. ensure that changes and current revision status of documents are identified,
d. ensure that relevant versions of applicable documents are available at points of use,
e. ensure that documents remain legible and readily identifiable,
f. ensure that documents of external origin are identified and their distribution controlled,
g. prevent the unintended use of obsolete documents and to apply suitable identification to
them if they are retained for any purpose.

4.2.4 Control of Quality Records


Quality records will be established and maintained to provide evidence of conformity to
requirements and the effective operation of the Quality Management System. Quality records will
remain legible, readily identifiable and retrievable. A documented procedure will be established
to define the controls needed for the identification, storage, protection, retrieval, retention time and
disposition of quality records.

Note: The Quality Management System documentation structure will be as follows:

Level 1
Quality Manual

Level 2
Procedures

Level 3
Work Instructions

Level 4
Forms & Records

Last Update: 04-APR-08 Quality Manual Rev D Page 15 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

5.0 Management Responsibility


5.1 Management Commitment
Top management shall provide evidence of its commitment to the development and implementation of
the quality management system and continually improving its effectiveness by:
a. communicating to Tech Circuits employees the importance of meeting customer as well as
regulatory and legal requirements,
b. establishing and reviewing the quality policy,
c. ensuring that quality objectives are established and reviewed,
d. conducting scheduled Management reviews and,
e. ensuring the availability of all necessary resources.

5.2 Customer Focus


Top management will ensure that customer requirements are determined and met with the aim of
enhancing customer satisfaction. Methods by which we accomplish this are covered in Section 8.2.1

5.3 Quality Policy


Top Management shall ensure that the quality policy:
a. is appropriate to the purpose of Tech Circuits, Inc.,
b. includes a commitment to comply with requirements and to continually improve the
effectiveness of the quality management system,
c. provides a framework for establishing and reviewing quality objectives,
d. is communicated and understood at appropriate levels in the company, and
e. is reviewed by Top Management for continuing suitability.

5.4 Planning
5.4.1 Quality Objectives
Top management shall ensure that quality objectives, including those needed to meet requirements
for product (Ref. Section 7.1a), are established at relevant functions and levels within Tech
Circuits. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality Management System Planning


Top management shall ensure that,
a. the planning and the quality management system is carried out in order to meet the
requirements given in Section 4.1, as well as the quality objectives, and
b. the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.

Last Update: 04-APR-08 Quality Manual Rev D Page 16 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

5.5 Responsibility, Authority and Communication


5.5.1 Responsibility and Authority
Top management will ensure that the responsibilities and authorities are defined and
communicated within Tech Circuits, Inc. (See Organization Flow Chart, Sec. III)

5.5.2 Management Representative


Top Management shall appoint members of management who, irrespective of other
responsibilities, shall have responsibility and authority that includes:
a. ensuring that processes of the quality management system are established, implemented
and maintained,
b. reporting to top management on the performance of the quality management system and
any needs for improvement, and
c. ensuring the promotion of awareness of customer requirements throughout Tech Circuits.

NOTE: The responsibility of a management representative may include liaison with


external parties on matters relating to the quality management system.

5.5.3 Internal Communication


Top management will ensure that appropriate communication processes are established within
Tech Circuits and that communication takes place regarding the effectiveness of the quality
management system.

5.6 Management Review


5.6.1 General
Top Management will review Tech Circuits’ quality management system at planned intervals to
ensure its continuing suitability, adequacy and effectiveness. The review will include assessing
opportunities for improvement and the need for changes to the quality management system,
including the Quality Policy and quality objectives. Records from management reviews will be
maintained (Ref. 4.2.4)

5.6.2 Review Input


The input to management review will include information on,
a. results of audits,
b. customer feedback,
c. process performance and product conformity,
d. status of preventive and corrective actions,
e. follow up actions from previous management reviews,
f. changes that could affect the quality management system, and
g. recommendations for improvement.

5.6.3 Review Output


The outputs from the management review shall include any decisions and actions related to,
a. improvement of the effectiveness of the quality management system and its processes,
b. improvement of product related to customer requirements, and
c. resource needs.

Last Update: 04-APR-08 Quality Manual Rev D Page 17 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

6.0 Resource Management


6.1 Provision of Resources
Tech Circuits, Inc. shall determine and provide the resources needed:
a. to implement and maintain the quality management system and continually improve its
effectiveness, and
b. to enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources


6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of
appropriate education, training, skills and experience.

6.2.2 Competence, Awareness and Training


Tech Circuits shall,
a. determine the necessary competence for personnel performing work affecting product
quality,
b. provide training or take other actions to satisfy these needs,
c. evaluate the effectiveness of the action taken,
d. ensure that its employees are aware of the achievement of the quality objectives, and
e. maintain appropriate records of education, training skills and experience (Ref. 4.2.4).

6.3 Infrastructure
Tech Circuits, Inc. shall determine, provide and maintain the infrastructure needed to achieve
conformity to product requirements. Infrastructure includes, as applicable,
a. buildings, workspace and associated utilities,
b. process equipment (both hardware and software)
c. supporting services (such as transport or communication).

6.4 Work Environment


Tech Circuits, Inc. will determine and manage the work environment needed to achieve conformity to
product requirements. All work areas shall comply with safety, regulatory and environmental
standards.

Last Update: 04-APR-08 Quality Manual Rev D Page 18 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

7.0 Product Realization


7.1 Planning of Product Realization
Tech Circuits, Inc. will plan and develop the processes needed for product realization. Planning of
product realization will be consistent with the requirements of the other processes of the quality
management system (Ref. 4.1). In planning the processes for realization of product Tech Circuits shall
determine the following, as appropriate,
a. Quality objectives and requirements for the product,
b. IPC Standard for the circuit board industry as applicable
c. the need to establish processes, documentation and provide resources specific to the product,
d. required verification, validation, monitoring, inspection and test activities specific to the
product and the criteria for product acceptance,
e. records needed to provide evidence that the realization process and resulting product meet
requirements (Ref. 4.2.4).
f. The output of this planning will be in a form suitable for Tech Circuit’s method of operations.
(Work instructions through the Bar Code JTS System).

7.2 Customer-Related Processes


7.2.1 Determination of Requirements Related to the Product
Tech Circuits, Inc. shall determine,
a. requirements specified by the customer, including the requirements for delivery and post-
delivery activities,
b. requirements not stated by the customer but necessary for specified use or an intended
use, where known,
c. statutory and regulatory requirements related to the product, and,
d. any additional requirements determined by Tech Circuits.

7.2.2 Review of Requirements Related to the Product


Tech Circuits, Inc. will review the requirements related to the product. This review shall be
conducted prior to Tech Circuits’ commitment to supply a product to the customer (e.g.
submission of a tender, acceptance of a contract or order, acceptance of changes to contracts or
orders) and shall ensure that,
a. product requirements are defined and
b. contract or order requirements differing from those previously expressed (e.g. in a tender
or quotation) are resolved,
c. Tech Circuits has the ability to meet defined requirements.
Records of the results of the review and actions arising from the review will be maintained (Ref.
4.2.4).
Where the customer provides no documented statement of requirements, the customer
requirements will be confirmed by Tech Circuits before acceptance.
Where product requirements are changed, the Tech Circuits shall ensure that relevant
documentation is amended, and relevant personnel are made aware of the changed requirements.

Last Update: 04-APR-08 Quality Manual Rev D Page 19 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

7.2.3 Customer Communication


Tech Circuits shall identify and implement arrangements for communication with customers
relating to,
a. product information,
b. enquiries, contracts or order handling, including amendments, and
c. customer feedback, including customer complaints.

7.3 Design and Development


Not Applicable Exclusion per sec. 1.2 of ISO 9001:2000 Standard

7.4 Purchasing
7.4.1 Purchasing Process
Tech Circuits shall ensure specific purchased product conforms to requirements. The type and
extent of control applied to the supplier and the purchased product shall be dependent upon the
effect of the purchased product on subsequent product realization or the final product.
Tech Circuits shall evaluate and select suppliers based on their ability to supply product in
accordance with Tech Circuit’s requirements. Criteria for selection, evaluation and re-evaluation
shall be established. Records of the results of evaluations and any necessary actions arising from
the evaluations will be maintained (Ref. 4.2.4).

7.4.2 Purchasing Information


Purchasing information will describe the product to be purchased, including where appropriate,
a. requirements for approval of the product, procedures, processes and equipment,
b. requirements for qualifications of personnel, and
c. Quality Management System requirements.
Tech Circuits, Inc. shall ensure the adequacy of specified purchase prior to their communication to
the supplier.

7.4.3 Verification of Purchased Product


Tech Circuits, Inc. shall establish and implement the inspection or other activities necessary for
ensuring that purchased product meets specified purchased requirements.
Where Tech Circuits or its customer intends to perform verification activities at the supplier’s
premises, Tech Circuits shall state the intended verification arrangements and method of product
release in the purchasing information.

Last Update: 04-APR-08 Quality Manual Rev D Page 20 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

7.5 Production and Service Provision


Not Applicable Exclusion per sec. 1.2 of ISO 9001:2000 Standard

7.5.1 Control of Production (and Service Provision)


Tech Circuits, Inc. shall plan and carry out production provision under controlled conditions.
Controlled conditions shall include, as applicable,
a. the availability of information that describes the characteristics of the product,
b. the availability of work instructions, as necessary,
c. the use of suitable equipment,
d. the availability and use of measuring and monitoring devices
e. the implementation of monitoring and measuring devices, and
f. the implementation of release, delivery and applicable post-delivery activities.

7.5.2 Validation of Processes for Production (and Service) Provision


Tech Circuits will validate any processes for production provision where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any processes where
deficiencies become apparent only after the product is in use. Validation will demonstrate the
ability of these processes to achieve planned results.
Tech Circuits will establish arrangements for those processes including, as applicable;
a. defined criteria for review and approval of these processes,
b. approval of equipment and qualification of personnel,
c. use of specific methods and procedures,
d. requirements for records (Ref. 4.2.4) and
e. revalidation.

7.5.3 Identification and Traceability


a. Tech Circuits shall identify all product by suitable means throughout product realization.
b. Tech Circuits shall identify the product status with respect to measurement and monitoring
requirements.
c. Tech Circuits shall control and record the unique identification of the product, where
traceability is a requirement (Ref. 4.2.4)

7.5.4 Customer Property


Tech Circuits shall exercise care with customer property while it is under its control or it is being
used. Tech Circuits shall identify, verify, protect, and safeguard customer property provided for
use or incorporation into the product.
If any customer property is lost, damaged or otherwise found to be unsuitable for use shall be
reported to the customer and records maintained (Ref. 4.2.4).
Note: Customer property may include intellectual property (e.g. Information provided in
confidence, specifications, drawings, etc.).

7.5.5 Preservation of Product


Tech Circuits, Inc. shall preserve conformity of product during internal processing and delivery to
the intended destination. This preservation shall include identification, handling, packaging,
storage and protection. Preservation will also apply to the constituent parts of a product.

Last Update: 04-APR-08 Quality Manual Rev D Page 21 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

7.6 Control of Monitoring and Measuring Devices


Tech Circuits shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring devices needed to provide evidence of conformity of product to determined
requirements (Ref. 7.2.1).
Tech Circuits will establish processes to ensure that monitoring and measurement can be carried out
and are carried out in a manner that is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall,
a. be calibrated or verified at specific intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist,
the basis used for calibration or validation shall be recorded;
b. be adjusted or re-adjusted as necessary;
c. be identified to enable the calibration status to be determined;
d. be safeguarded from adjustments that would invalidate the measurement result;
e. be protected from damage and deterioration during handling, maintenance and storage.

In addition, Tech Circuits will assess and record the validity of the previous measuring results when
the equipment found not to conform to requirements. Tech Circuits will take appropriate action on the
equipment and any product affected. Records of the results of calibration and validation will be
maintained (Ref. 4.2.4). Recall of product will be at the request of the customer and/or Tech Circuits
after notification of any significant measurement non-conformity. Field investigations may substitute
recall with customer concession.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application will be confirmed. This will be undertaken prior to initial
use and reconfirmed as necessary. Reference ISO 10012-1 and ISO 10012-2

Last Update: 04-APR-08 Quality Manual Rev D Page 22 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

8.0 Measurement, Analysis and Improvement


8.1 General
Tech Circuits, Inc. shall plan and implement the monitoring, measurement, analysis and improvement
processes needed,
a. to demonstrate conformity of the product,
b. to ensure conformity of the quality management system, and
c. to continually improve the effectiveness of the quality management system.
This shall include the determination of applicable methods, including statistical techniques and the
extent of their use.

8.2 Monitoring and Measurement


8.2.1 Customer Satisfaction
As one of the measurements of performance of the quality management system, Tech Circuits
shall monitor information relating to customer perception as to whether Tech Circuits has met
customer requirements. The methods for obtaining and using this information shall be in the form
of an annual Internet based survey, On-Time delivery data and RMA reports all of which shall be
reviewed by Top Management on a monthly basis (Rev. 5.1 and 5.2).

8.2.2 Internal Audit


Tech Circuits, Inc. shall conduct internal audits at planned intervals to determine whether the
quality management system
a. conforms to the planned arrangements (Ref. 7.1),
b. conforms to the requirements of this international standard and to the quality
management system requirements established by Tech Circuits and,
c. is effectively implemented and maintained.
Tech Circuits shall plan the audit program, taking into consideration the status and importance of
the processes and areas to be audited as well as the results of previous audits. The audit criteria,
scope, frequency and methods shall be defined. Selection of auditors and conduct of auditors shall
ensure objectivity and impartially of the audit process. Auditors will not audit their own work.
The responsibilities and requirements for planning and conducting audits, and reporting results
and maintaining records (Ref. 4.2.4) will be defined in a documented procedure.
Management responsible for the area being audited will ensure that actions are taken without
undue delay to eliminate detected non-conformances and their causes. Follow-up activities will
include the verification of the actions taken and the reporting of verification results (Ref. 8.5.2).
Follow-up activities shall also include the verification of the implementation of Corrective
Actions, and the reporting of verification results. Reference ISO 10011-1, ISO 10011-2 and ISO
10011-3.

8.2.3 Monitoring and Measurement of Processes


Tech Circuits shall apply suitable methods for monitoring and, where applicable, measurement of
the quality management system processes. These methods shall demonstrate the ability of the
processes to achieve planned results. When planned results are not achieved, correction and
corrective action will be taken as appropriate to ensure conformity of the product.

Last Update: 04-APR-08 Quality Manual Rev D Page 23 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

8.2.4 Monitoring and Measurement of Product


Tech Circuits shall measure and monitor the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product
realization process in accordance with planned arrangements (Ref. 7.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate
the person(s) authorizing release of product (Ref. 4.2.4).
Product release and service delivery shall not proceed until all the planned arrangements (Ref. 7.1)
have been satisfactorily completed, unless otherwise approved by a relevant authority, and where
agreed to by the customer.

8.3 Control of Non-conforming Product


Tech Circuits shall ensure that product which does not conform to product requirements is identified
and controlled to prevent unintended use or delivery. The controls and related responsibilities and
authorities for dealing with non-conforming product will be defined in a documented procedure.
Tech Circuits will deal with non-conforming product by one or more of the following ways,
a. by taking action to eliminate the detected nonconformity,
b. by authorizing its use, release or acceptance under concession by a relevant authority and
where applicable, by the customer,
c. by taking action to preclude its original intended use or application.
Records of the nature of non-conformities and any subsequent actions taken, including concessions
obtained, shall be maintained (Ref.4.2.4).
When non-conforming product is corrected it will be subject to re-verification to demonstrate
conformity to the requirements.
When non-conforming product is detected after delivery or use has started, Tech Circuits will take
action appropriate to the effects, or potential effects of the nonconformity.

8.4 Analysis of Data


Tech Circuits will determine, collect and analyze appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of the
effectiveness of the quality management system can be made. This includes data generated as a result
of monitoring and measurement and for other relevant sources.
The analysis of data will be provide information relating to,
a. customer satisfaction (Ref. 8.2.1),
b. conformity to product requirements(Ref. 7.2.1),
c. characteristics and trends of processes and products including opportunities for preventive
action, and
d. suppliers.

Last Update: 04-APR-08 Quality Manual Rev D Page 24 of 25


Tech Circuits, Inc. ISO 9001:2000 Quality Manual

8.5 Improvement
8.5.1 Continual Improvement
Tech Circuits will continually improve the effectiveness of the quality management system
through the use of the Quality Policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review.

8.5.2 Corrective Action


Tech Circuits, Inc. shall take corrective action to eliminate the cause of non-conformity’s in order
to prevent recurrence. Corrective action shall be appropriate to the effects of the nonconformities
encountered.
A documented procedure will be established to define requirements for,
a. reviewing non-conformities (including customer complaints),
b. determining the causes of nonconformities,
c. evaluating the need for actions to ensure that nonconformities do not recur,
d. determining and implementing action needed,
e. records of the results of action taken (Ref 4.2.4), and
f. reviewing corrective action taken.

8.5.3 Preventive Action


Tech Circuits, Inc. shall determine action to eliminate the causes of potential nonconformities in
order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the
potential problems.
A documented procedure will be established to define requirements for,
a. determining potential nonconformities and their causes,
b. evaluating the need for action to prevent occurrence of non-conformities
c. determining and implementing action needed,
d. records of results of action taken (Ref. 4.2.4), and
e. reviewing preventive action taken.

Last Update: 04-APR-08 Quality Manual Rev D Page 25 of 25

You might also like