Quality System Manual: ISO 13485 U.S. QSR (21 CFR 820)

QUALITY SYSTEM MANUAL
ISO 13485 U.S. QSR (21 CFR 820)
EXSURCO MEDICAL
10804 GREEN ROAD BIRMINGHAM OH, 44889
QM-1_00001
CONFIDENTIAL REVISION 01
INTRODUCTION
Exsurco Medical Inc., developed and implemented a Quality Management System in order to document
the company’s best business practices, better satisfy the requirements and expectations of its customers
and improve the overall management and performance of the company.
The Quality Management System of Exsurco meets the requirements of the international standards ISO
13485 and U.S.QSR (21 CFR 820). This system addresses the design, development, production,
installation, and servicing of the company’s product(s).
The manual is divided into eight sections that correlate to the Quality Management System sections of
ISO 13485 and U.S.QSR (21 CFR 820). Each section begins with a statement outlining Exsurco’s
commitment to implement the basic requirements of the referenced Quality Management System
section. Each statement is followed by specific information pertaining to the procedures that describe
the methods used to implement the necessary requirements. In Appendix C a list of all procedures is
referenced.
This manual describes the Quality Management System, delineates authorities, inter-relationships and
responsibilities of the personnel responsible for performing within the system. The manual also provides
procedures or references for all activities comprising the Quality Management System to ensure
compliance to the necessary requirements of the standard.
This manual is used internally to guide the company’s employees through the various requirements of
the ISO and US QSR standards that must be met and maintained in order to ensure customer
satisfaction, continuous improvement and provide the necessary instructions that create an empowered
work force.
This manual is used externally to introduce our Quality Management System to our customers and other
external organizations or individuals. The manual is used to familiarize them with the controls that have
been implemented and to assure them that the integrity of the Quality Management System is
maintained and focused on customer satisfaction and continuous improvement.
______________________________________________ __________________
Sara Ann MacKinlay, General Manager Date
______________________________________________ __________________
Swasita Saigal, Regulatory Affairs Manager Date
______________________________________________ __________________
Kayli Camp, Associate Quality Manager Date

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COMPANY PROFILE
Exsurco Medical is a leading-edge equipment manufacturer for tissue bank and surgical applications
committed to improving excision results by providing devices for tissue recovery and processing.. Its
products have been designed to meet the applicable regulatory requirements and the requirements of its
customers, but are propriety in design, not designed to customer specifications. Exsurco Medical is
located at 10804 Green Road Birmingham, OH 44889 (corporate location).
QUALITY POLICY
As a responsible company, Exsurco Medical will conduct business with integrity and our commitment is
based on “Quality without Compromise”. Our policy is as follows:

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TABLE OF CONTENTS
Company Profile ....................................................................................................................................... 2
Quality Policy ........................................................................................................................................... 2
Table of Contents ...................................................................................................................................... 3
1.0 Scope ................................................................................................................................................... 4
2.0 References ........................................................................................................................................... 4
3.0 Terms and Definitions ......................................................................................................................... 4
4.0 Quality Management System .............................................................................................................. 4
4.0 Quality Management System Continued ............................................................................................ 5
5.0 Management Responsibility................................................................................................................ 5
5.0 Management Responsibility Continued .............................................................................................. 6
6.0 Resource Management ........................................................................................................................ 7
6.0 Resource Management Continued ...................................................................................................... 8
7.0 Product Realization ............................................................................................................................. 9
8.0 Measurement, Analysis and Improvement ........................................................................................ 17
Appendix A: Quality Mangement System Process ..................................................................................... 22
Appendix B: Organizational Chart ............................................................................................................. 23
Appendix C: List of Procedures for Reference ........................................................................................... 24

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1.0 SCOPE
1.1 GENERAL
1.1.1 The Quality System defined in this manual is designed to meet the needs of Exsurco
Medical in the operation of its business, and has been developed from the business principles
expressed in the Mission Statement, and the Quality Policy.
1.2 APPLICATION
1.2.1 This Quality System Manual (QSM) outlines the overall structure and content of the
quality system developed by and for the use of Exsurco Medical.
2.0 REFERENCES
2.1 GENERAL
2.1.1 The Exsurco Medical Quality Management System has been developed to be in
compliance with the applicable requirements and most recent revision of the ISO 13485 and U.S.
QSR (21 CFR 820).
3.0 TERMS AND DEFINITIONS

3.1 GENERAL
3.1.1 For the purposes of this document, the terms and definitions given in ISO 13485 and U.S.
QSR (21 CFR 820) apply.
4.0 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL
4.1.1 Exsurco Medical has established, documented, implemented and maintained a Quality
Management System (QMS) in accordance with the requirements of ISO 13485 and U.S.QSR (21
CFR 820). The effectiveness of the QMS is maintained and the system continually improved
through the use of the quality policy, quality objectives, audit results, analysis of data, corrective
and preventive action and management review. To design and implement the QMS Exsurco
Medical has:
• Identified the processes needed for the QMS and their application throughout the
organization.
• Determined the sequence and interaction of these processes.
• Determined criteria and methods needed to ensure that the operation and control of the
processes are effective, and documented them in quality plans and work instructions.
• Ensured the continuing availability of resources and information necessary to achieve
planned results and continual improvement of these processes.
• Ensured that Exsurco employees are trained to understand our Quality procedures and
their application.
• Established systems to monitor, measure and analyze these processes.
• Established processes to identify and implement actions necessary to achieve planned
results and continual improvement of these processes.

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4.0 QUALITY MANAGEMENT SYSTEM CONTINUED
4.2 DOCUMENTATION REQUIREMENTS
4.2.1 The QMS documentation includes:
• A documented Quality Policy
• Quality Objectives
• This Quality Manual
• Documented Procedures, Work Instructions and Forms.
• Documents identified as needed for the effective planning, operation and control of our
processes,
• Quality Records
• Any other documentation specified by national or regional regulations.
• Each procedure, activity or special arrangement that has been documented is also
implemented and maintained.
4.3 CONTROL OF PROCEDURES AND RECORDS
4.3.1 Procedures to control the development, release and revision of documents have been
established (See Appendix C for reference).
5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT
5.1.1 Executive management has been actively involved in implementing the quality
management system (QMS). It has provided the vision and strategic direction for the growth of
the QMS, and established quality objectives and the quality policy.
5.1.2 The procedure covering Management Responsibility (See Appendix C for reference) is
established and maintained. Executive management provides evidence of its commitment to
meeting requirements for the design, manufacture, distribution, and support of safe and effective
medical devices through the quality management system and maintaining its effectiveness by:
• Communicating the importance of meeting customer, statutory, and regulatory
requirements throughout the organization.
• Establishing quality objectives.
• Establishing the quality policy.
• Conducting at a minimum bi-annual Management Reviews.
• Reviewing the quality system during Management Reviews.
• Ensuring that the resources necessary to maintain and continually improve the QMS are
available, including a quality assurance unit.

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5.0 MANAGEMENT RESPONSIBILITY CONTINUED
5.2 CUSTOMER FOCUS
5.2.1 Exsurco’s Executive Management ensures that current and future customer requirements
and regulatory requirements are determined and are met.
5.2.2 Executive management ensures that customer requirements are understood and met, by
requiring compliance with documented customer communication procedures. Customer
requirements are determined, converted into internal requirements, and communicated to the
appropriate employees in our organization.
5.3 QUALITY POLICY
5.3.1 The Quality Policy has been established to provide the framework for the development
and implementation of a QMS that will assure design, product, and customer service quality.
The policy clearly states our commitment to regulatory compliance and meeting customer
requirements and provides the framework for establishing quality objectives. It is annually
reviewed for suitability during the company’s annual Strategic Planning process, and is
communicated throughout the organization.
5.4 PLANNING
5.4.1 Quality objectives
5.4.1.1 Executive Management ensures that quality objectives, including those needed
to meet product or service requirements, are established at relevant functions and levels
at Exsurco Medical. These objectives define the relevant quality practices, resources
and activities. Quality objectives are measurable and consistent with the quality policy.
5.4.2 Quality Management System Planning
5.4.2.1 QMS planning consists of the implementation, updating and maintenance of
the Quality Manual and the supporting processes and procedures. Quality planning also
includes maintaining the integrity of the QMS when changes are planned and
implemented.
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 Responsibility and authority
5.5.1.1 Exsurco Medical defines and documents responsibilities and authorities in job
descriptions and organizational charts and procedures. Responsibilities and authorities
are communicated within the organization.
5.5.2 Management representative
5.5.2.1 The General Manager, who is appointed by the CEO of Exsurco Medical has
been assigned the role of Management Representative. The Management Representative
has the authority and responsibility to ensure that the QMS requirements are established,
implemented and maintained and that the system complies with the requirements of the
regulations and standards listed in section 2.1. The organizational structure provides the
Management Representative with unobtrusive access to the quality conduct of the
organization.
5.5.2.2 The role of management representative includes the reporting to Executive
Management on the performance of the QMS through the management review process
and creating awareness throughout the organization of statutory, regulatory, and
customer requirements.

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5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION CONTINUED
5.5.3 Internal communication
5.5.3.1 Executive Management ensures that the appropriate communication processes
are established and that communication takes place regarding the effectiveness of the
QMS.
5.5.3.2 Communication is achieved through internal auditing, training, meetings,
nonconformance, corrective actions, preventive actions, complaint feedback,
investigations, management reviews and any other tool that may be developed and
implemented to monitor the effectiveness of the QMS or to continually improve the
system.
5.6 MANAGEMENT REVIEW
5.6.1 Executive Management and the Management Representative review the QMS at planned
intervals (at a minimum annually). The purpose of the review is to assess the adequacy,
effectiveness and continuing suitability of the QMS. The review includes assessing opportunities
for improvement and the need for changes to the QMS, including the quality policy and quality
objectives. Records from the management review meetings are maintained.
6.0 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES
6.1.1 Exsurco Medical determines and provides the resources, including equipment, facilities
and personnel, needed to implement the QMS, to maintain its effectiveness and to meet
regulatory and customer requirements.
6.1.2 Resource allocation is primarily the responsibility of Executive Management. Allocation
begins at the annual budgeting process and continues throughout the year as regulatory or
customer requirements change. It is the responsibility of department management to identify and
allocate the appropriate resources for quality related activities.
6.2 HUMAN RESOURCES
6.2.1 Exsurco Medical determines the necessary competence level for personnel and ensures that
personnel have the necessary skills, experience, and education to perform their assigned
responsibilities adequately. The company provides training as necessary to keep skills current.
Written job descriptions contain the minimum education, experience and skill requirements for
each position.
6.2.2 Competence, training and awareness.
6.2.2.1 Department management and Human Resources determines the necessary
competence for personnel performing work affecting quality.
6.2.2.3 Department management and Human Resources identifies and organizes
training to ensure that each employee or contracted Associate attains the desired
performance. Appropriate supervision is provided for personnel undergoing training.
6.2.2.4 Training effectiveness is evaluated through oral or written examinations,
observance of job performance and/or job performance evaluations.
6.2.2.5 Management has the responsibility to ensure that all personnel understand the
functions they are to perform and are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives.

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6.2.2.6 Records of employee or contracted personnel education, training, skills and
experience are maintained. The records are readily available and include the date on
which personnel are authorized and/or confirmed to be competent at a task.
6.0 RESOURCE MANAGEMENT CONTINUED

6.3 INFRASTRUCTURE
6.3.1 Exsurco maintains an infrastructure necessary to achieve product and service quality
standards and QMS compliance.
6.3.1.1 Buildings, workspaces and associated utilities are suitably designed and
configured to facilitate cleaning, maintenance and orderly process flow.
6.3.1.2 Process equipment and supporting services are provided and maintained as
needed for conformity to product/service requirements.
6.3.1.3 The layout of workspaces ensures that appropriate separation of activities is
maintained to prevent adverse occurrences, such as contamination or mix-ups.
6.3.1.6 Sewage, trash and other refuse is removed from buildings and premises in a
safe and sanitary manner.
6.3.1.7 Exsurco Medical maintains buildings in a good state of repair.
6.3.1.8 Documented procedures are established for maintenance activities, including
their frequency, when such activities or lack thereof can affect product/test quality.
Records of maintenance are maintained.
6.4 WORK ENVIRONMENT
6.4.1 Exsurco Medical ensures that the work environment necessary to achieve conformity to
product/service requirements is achieved through the following activities:
6.4.1.1 Exsurco Medical establishes documents outlining the health, cleanliness and
clothing of personnel if contact between an employee and the product or work
environment could adversely affect the product.
6.4.1.2 Exsurco Medical provides personnel appropriate clothing and personal
protective equipment for the duties they perform as needed.
6.4.1.3 Exsurco Medical ensures that adequate clean toilet facilities and washing
facilities are provided, including hot and cold water, soap and single-service towels that
are accessible to work areas.
6.4.1.4 Exsurco Medical maintains all buildings in a clean and sanitary condition free
of infestation by rodents, birds, insects or other vermins.
6.4.1.5 Exsurco Medical establishes and maintains documented procedures for
sanitation describing methods and responsibility. Use of cleaning and sanitizing agents,
as well as the use of insecticides is detailed to ensure the prevention of contamination or
harm to product or testing activities.
6.4.1.6 Exsurco Medical establishes documents outlining the work environment
requirements, such as humidity, temperature or lighting, if the work environment could
adversely affect the product quality. Procedures for monitoring work environment
conditions are also established and records of monitoring are maintained.
6.4.1.9 Exsurco Medical ensures personnel who must work temporarily under special
environmental conditions are appropriately trained or supervised by a trained Associate.

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6.4.1.10 Exsurco Medical establishes documents outlining the procedure to follow in the
event products are contaminated in order to prevent contamination of other products, the
work environment or personnel.
7.0 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION
7.1.1 Exsurco Medical uses a product development process that utilizes a series of Gates and
Stages for product realization (Stage Gate Process ®) and is consistent with other processes of the
QMS. The following are considerations for the planning of product realization;
• Determination of product performance requirements
• Determination of product and process specifications
• Determination of purchasing requirements
• Determination of information requirements
• Determination of compliance requirements
• Other requirements that may not be specified, but may be necessary for intend use.
7.1.2 Risk management is an integral part of the product realization process at established stages
in the product life cycle.
7.2 CUSTOMER RELATED PROCESSES
7.2.1 Determination of requirements related to the product.
7.2.1.1 Exsurco Medical only produces products to its own product specifications, and
does not produce custom products based upon customer specifications.
7.2.1.2 Product requirements for Exsurco-designed products are identified as part of
the Exsurco implementation of the Stage Gate process, and are recorded in the
Integrated Product Definition.
7.2.1.3 Exsurco Medical determines the following:
• User Requirements specified by the customer, including requirements
for delivery.
• Requirements not stated by the customer, but necessary for specified
or known intended use.
• Statutory and regulatory requirements.
7.2.2 Review of requirements related to the product
7.2.2.1 Exsurco Medical conducts contract review to ensure customer requirements are
defined and documented in order to identify and resolve any differences between the
customer’s expectations and Exsurco’s ability to meet the requirements.
7.2.2.2 Contract review is conducted prior to committing to supply a product or service
to a customer and to ensure:
• Product/service requirements, including special requirements, are
defined and accepted.
7.2 CUSTOMER RELATED PROCESSES CONTINUED

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• Any contract or order requirements differing from those previously
expressed are resolved.
• Exsurco Medical has the ability to meet the defined requirements.
• Special training of personnel, equipment or materials have been
identified.
7.2.2.3 Where the customer provides no documented statement of requirement,
Exsurco Medical confirms the customer requirements prior to acceptance.
7.2.3 Customer Communication
7.2.3.1 Exsurco Medical determines and implements arrangements for communicating
with customers. This communication involves product/service information, inquiries,
contracts or order handling, customer feedback including complaints and advisory
notices.
7.3 DESIGN AND DEVELOPMENT
7.3.1 Design and development planning
7.3.1.1 Established and documented procedures identify the sequence and
interrelationship of design and development activities. These activities will be planned
and executed using a process that uses a series of Gates and Stages to meet the needs of
Exsurco Medical.
7.3.1.2 The Project Manager is responsible for managing the development and
execution of design and development plans and the execution of the process. This
responsibility will include interfacing with different functional areas to assure effective
communication and clear execution of responsibilities in line with each design and
development plan.
7.2.1.3 Design and development plans are reviewed for adequacy and approved before
moving through each gate to the next stage. Records of the review and approval are
maintained in a Design History File.
7.3.2 Design and development inputs
7.3.2.1 Design inputs will be identified and documented within the design and
development process, and will include;
• Functional, performance and safety requirements according to
intended use
• Product performance requirements;
• Applicable statutory and regulatory requirements;
• Customer-specified requirements where applicable.
• Outputs of risk management
7.3.2.2 Design inputs are reviewed for adequacy and approved before moving through
each gate to the next stage. Records of the review and approval are maintained in a
Design History File (DHF).

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7.3 DESIGN AND DEVELOPMENT CONTINUED
7.3.3 Design and Development Outputs

7.3.3.1 Design and development outputs will be documented and maintained in a
Design History File (DHF) for each type of finished component produced by Exsurco
Medical. At planned intervals in the design and development process, design outputs
will be verified against design inputs, and the results of those verifications will be
approved and recorded.
7.3.3.2 Design and development outputs will;
• meet applicable statutory and regulatory requirements
• meet the approved design input requirements
• provide the information necessary for purchasing, production, and
service provision
• define the acceptance requirements for the device, and
• define the essential requirements for safe and proper use of the device
7.3.3.3 For devices that complete the design and development process, design and
development outputs will be recorded and maintained in a Device Master Record
(DMR). The DMR will be reviewed and approved prior to release of the device.
7.3.4 Design and development review
7.3.4.1 Design reviews are conducted at planned intervals during the design and
development process. Design reviews will be used to assure that the design process
continues to align with design and development plans, or to assure that the design
outputs match design input requirements. If it is determined that changes to either plans,
designs, or design input requirements need to be made, that the changes to the plan, the
product, or the requirements are documented and approved.
7.3.4.2 Design Engineering is responsible for assuring that design reviews are
conducted and for assuring that records of those reviews are maintained.
7.3.4.3 Participants in the design review process include representatives of functions
concerned with the design and development stage(s) being reviewed as well as other
subject matter experts (SME) as appropriate.
7.3.4.4 Records of design reviews will be recorded and maintained in the Design
History File (DHF).
7.3.5 Design and Development Verification
7.3.5.1 Design and development verification is conducted in accordance with design
and development plans during the design and development stage of the development
process, and is the responsibility of Design Engineering. Results of verification activities
and any resulting actions necessary will be recorded and maintained in the DHF. Design
verification will be conducted using units under actual or simulated production
conditions.
7.3.6 Design and Development validation
7.3.6.1 Design and development validation is conducted in accordance with design and
development plans during the testing and validation stage of the development process to
insure the resulting product is capable of meeting requirements for intended use. This
validation must be completed prior to delivery or implementation of the product. Results
of validation activities will be recorded and maintained in the DHF.

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7.3 DESIGN AND DEVELOPMENT CONTINUED
7.3.6.2 Clinical and/or performance evaluations are performed as required by national
or regional regulations and as appropriate for the nature and intended use of the device.
7.3.6.3 Design validation will be conducted using units under actual or simulated
production conditions.
7.3.7 Control of design and development changes
7.3.7.1 Exsurco Medical has established documented procedures for design changes.
7.3.7.2 Design and Development changes are identified and records are maintained.
7.3.7.3 Changes are reviewed, verified and validated, as appropriate, and approved
before implementation. The review of design and development changes include an
evaluation of the effect of the changes on component parts and product already delivered
or testing previously conducted.
7.3.7.4 Records of the results of the review of changes and any necessary actions are
maintained.
7.3.8 Device Master Record (DMR)
7.3.8.1 A DMR is maintained for each type of finished component and includes or
refers to the location of the following information:
• Device specifications including appropriate drawings, composition,
formulation, component specifications and software specifications.
• Production process specifications including the appropriate equipment
specifications, production methods, production procedures and production
environment specifications.
• Quality assurance procedures and specifications including acceptance
criteria and the quality assurance equipment to be used.
• Packaging and labeling specifications including methods and
processes used.
7.3.9 Design transfer
7.3.9.1 Exsurco Medical has established documented procedures for design transfer.
Design transfer is provided in a manner that ensures that the design is correctly
translated into production specifications.
7.3.10 Design History File (DHF)
7.3.10.1 Exsurco Medical establishes and maintains a DHF for each type of device in
which Exsurco Medical is responsible for the design control. The records contain
information that demonstrates that the design was developed in accordance with the
approved design plan.
7.3.10.2 The DHR includes at a minimum, the dates of manufacture, the quantity
manufactured, the quantity released for distribution, acceptance records, the primary
identification label and labeling used, any device identification and control number(s)
used.

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7.4 PURCHASING
7.4.1 Purchasing process
7.4.1.1 Exsurco Medical has established documented procedures to ensure purchased
product conforms to specified purchase requirements.
7.4.1.2 Exsurco Medical has established documented procedures for supplier
assessment that includes criteria for selection, evaluation and re-evaluation. The
evaluation includes the supplier's ability to supply product in accordance with Exsurco
Medical’s requirements. The evaluations are documented. The type and extent of control
applied to the supplier and the purchased product is dependent upon the effect of the
purchased product on the final product realization. Documentation of approval is
maintained.
7.4.1.2 Records of supplier evaluations and any actions arising from those evaluations
will be maintained.
7.4.2 Purchasing information
7.4.2.1 Purchasing information will define or describe the requirements for the product
or service to be purchased. This information will be provided to the supplier as part of
the conditions of purchase of those products or services.
7.4.2.2 Where appropriate or necessary, purchasing information will include;
• Exsurco engineering design specifications and/or drawings,
• Exsurco quality requirements that differ from or are not specified in
engineering specifications and/or drawings,
• Requirements necessary for adherence to statutory or regulatory
requirements,
• Special requirements for the provision of information to accompany
product delivery,
• Special requirements for personnel, processes, or quality systems,
• Requirements that the supplier notify Exsurco Medical about any
changes to the product and/or service so that Exsurco can determine whether
those changes would affect the quality of a finished device, and
• Requirements for traceability where applicable.
7.4.2.3 Purchase requirements and specifications will be reviewed for adequacy prior to
issue to the supplier.
7.4.3 Verification of purchased product
7.4.3.1 Purchased products and/or services will be verified for compliance with
specified requirements prior to acceptance by Exsurco Medical. The type and extent of
verification performed is determined by the nature of the product and/or service, the
impact of that product or service on subsequent or finished products, and the historical
performance of the supplier.
7.4.3.2 Where verifications are to be performed at the supplier's premises, the
arrangements for verification and release of verified products will be agreed upon
between Exsurco Medical and the supplier prior to those verifications being performed.
7.4.3.3 Records of product verifications will be maintained.

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7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 Control of production and service provision
7.5.1.1 Production of devices by Exsurco Medical will be carried out under controlled
conditions, which include the following elements as part of a DMR and DHR:
• Product requirements and/or specifications, which will be defined by;
• design specifications, and/or
• purchasing requirements, and/or
• manufacturing and/or process specifications, and/or
• quality plans,
• Production processes, which will be defined by;
• standard operating procedures, and/or
• work instructions, and/or
• manufacturing process drawings, and/or
• production routings or job travelers,
• Suitable facilities, equipment, training, and tools,
• Monitoring and measuring of products and/or processes, which will be
defined by;
• suitable monitoring and measuring devices, and/or
• suitable measurement procedures, and/or
• reference materials or standards, where required, and/or
• defined workmanship criteria or samples when acceptance criteria
cannot otherwise be specified,
• Defined requirements and procedures for product labeling and
packaging, and
• Procedures for product release, delivery and post-delivery activities
where applicable,
• A traveler for each batch of medical components produced by Exsurco
Medical will be created and maintained, even if that batch only consists of one
device. That traveler and DHR will provide traceability to the device master
record, and will identify the number of devices produced and the number of
devices approved for distribution.

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7.5 PRODUCTION AND SERVICE PROVISION CONTINUED
7.5.2 Control of production and service provision—specific requirements
7.5.2.1 Cleanliness of product and cleanliness control
7.5.2.1.1 Requirements for product cleanliness will be determined prior to
placing the product on the market, and those requirements will be documented.
7.5.2.2.1 Control of work environments will be considered as part of the
evaluation of cleanliness requirements, as described in section 6.4.
7.5.2.3.1 Products that are to be provided to the customer as sterile, or products
that are to be provided as non-sterile and for which cleanliness is of
significance during use will be cleaned according to documented requirements.
7.5.2.4.1 Products that are to be provided to the customer and which must be
subjected to a cleaning process and/or sterilization by the customer prior to use
will have manufacturing materials or process agents removed according to
documented requirements prior to distribution.
7.5.3 Servicing activities
7.5.3.1 Where servicing is a specified requirement, procedures for the performance,
verification, and recording of those activities are governed by Product servicing
procedure.
7.5.3.2 Servicing activities that are related to remediation or correction of a deficiency
will be treated as complaints, and processed according to documented procedure.
7.5.3.3 A service report that represents an event which must be reported to the FDA will
automatically consider the report a complaint and will process it in accordance with the
requirements of 21 CFR 820.198.
7.5.4 Particular requirements for sterile medical devices
7.5.4.1 For products that are to be sold as sterile, Exsurco Medical will maintain records
of the sterilization process that was used for each sterilization batch. Sterilization records
will be traceable to each production batch of devices.
7.5.5 Validation of processes for production and service provision
7.5.5.1 General Requirements
7.5.5.1.1 Exsurco validates any processes for production and service 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 or the service has been delivered. Validation
demonstrates the ability of these processes to achieve planned results Exsurco
Medical has established arrangements for these processes including, as
applicable:
• Defined criteria for review and approval of the processes
• Approval of equipment and qualification of personnel
• Use of specific methods and procedures
• Requirements for records

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7.5.5.1.2 In those instances where software is a component of the final Exsurco
device, and that software affects the ability of the device to conform to
specified requirements, that software will be validated prior to its initial use and
for each revision of that software according to the documented procedure.
Records of those software validations will be maintained.
7.5.5.2 Particular requirements for sterile medical devices
7.5.5.2.1 For products that are to be sold as sterile, the sterilization process that
is to be used will be validated prior to first distribution of those products per the
documented procedure. Records of the validations of sterilization processes
will be maintained in the Design History File (DHF) for the device.
7.5.5.2.2 Process parameters used for each sterilization process will be
established during the validation process, and will be specified as a purchase
specification when sterilization activities are performed by an outside facility.
7.5.5.2.3 Process parameters used for each batch of sterilized products will be
maintained as part of the Device History Record (DHR) and traveler for that
batch, and sterilization records will be traceable for each batch of products.
7.5.6 Identification and traceability
7.5.6.1 Identification
7.5.6.1.1 Product will be suitably identified throughout all stages of product
realization, including through distribution and until receipt by the customer,
according to document
7.5.6.1.2 Devices that are returned from customers will be clearly identified to
assure that they are not mixed with new products, as per documented
procedure.
7.5.6.2 Traceability
7.5.6.2.1 Product traceability requirements will be defined early in the design
and development process. When traceability is an identified requirement, the
procedures used for traceability will be defined per the documented procedure,
and will include the extent of traceability requirements, the methods for
executing traceability, and the records required for that traceability.
7.5.6.2.2 Where traceability is a requirement, each device will be assigned a
unique identification, and records of that identification will be maintained.
7.5.6.3 Status Identification
7.5.6.3.1 The acceptance status of products will be identified by suitable means
throughout all stages of manufacturing, packaging and labeling, storage,
dispatch or delivery and post-delivery activities, as required.

Page 16 of 26
7.5.7 Customer property
7.5.7.1 Customer property will be identified, verified, and protected while under the
possession or control of Exsurco Medical. Where there is damage to or loss of customer
property, or if it is found to unsuitable for use, the customer will be notified of this, and
records maintained.
7.5.7.2 Customer property that is returned to Exsurco Medical for servicing will be
tracked and controlled until final disposition and/or return of that property to the
customer. The customer will be notified of the suitability of the product for service and
the status of that service.
7.5.8 Preservation of product
7.5.8.1 Product will be suitably packaged, handled, stored and shipped to protect the
quality and ensure conformity of the products throughout processing, assembly, storage,
and delivery, according to documented procedure. When special package or handling
requirements are required, they will be identified on the work order or in packaging
specifications.
7.5.8.2 Products that have limited shelf-life or that require special storage conditions will
be identified, handled, and stored as per the documented procedure.
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT
7.6.1 Exsurco Medical will develop quality plans to define and document the methods and
equipment to be used for the monitoring and measurement of products to ensure compliance to
product requirements.
7.6.2 Monitoring and measuring equipment will be calibrated or verified at specified intervals to
reference standards which are traceable to national standards (NIST) where possible, as defined
in the documented procedure. The calibration status of equipment will be suitably identified.
Records of calibration will be maintained.
7.6.3 Monitoring and measuring equipment will be stored, handled, and protected to assure that
accuracy and fitness for use are maintained, and to prevent unauthorized adjustment.
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL
8.1.1 Exsurco Medical plans and implements the monitoring, measurement, analysis and
improvement processes needed to:
8.1.1.1 Demonstrate the conformity of the product/service.
8.1.1.2 Ensure conformity of the QMS.
8.1.1.3 Maintain the effectiveness of the QMS.
8.1.2 The planning and implementation includes a determination of applicable methods,
including statistical techniques, and the extent of their use (See Appendix C for reference).

Page 17 of 26
8.2 INTERNAL AUDITS
8.2.1 Internal audits are conducted at planned intervals to determine whether the QMS
conforms to the planned arrangements, to applicable external standards and regulations and to
internal QMS requirements. The audits also are used to determine if the QMS is effectively
implemented and maintained.
8.2.2 The audit program is planned taking into consideration the status and importance of the
processes and areas to be audited, in addition to the results of previous audits. The audit criteria,
scope, frequency and methods are defined. The selection of auditors and conduct of audits ensure
objectivity and impartiality of the audit process. Auditors do not audit their own work.
8.2.3 A documented procedure is in place that defines the responsibilities and requirements
for planning and conducting audits, and for reporting results and maintaining records (See
Appendix C for reference).
8.2.4 Management responsible for the area being audited reviews the results and is responsible
for ensuring that actions are taken without undue delay to eliminate detected nonconformities and
their causes. Follow-up activities include the verification of the actions taken and the reporting of
verification results.
8.3 MONITORING AND MEASUREMENT
8.3.1 Feedback
8.3.1.1 Internal data (data from audits, monitoring of established performance metrics,
etc.), in addition to positive and negative customer generated data (complaints, surveys,
etc.) are used as feedback to determine whether customer requirements are being met, to
provide early warning of quality problems and for input into the corrective and
preventive action processes.
8.3.1.2 Procedures are maintained for receiving, documenting, reviewing and
evaluating complaints for products and service. These procedures and work instructions
(See Appendix C for reference) ensure the following:
• All complaints are processed in a uniform and timely manner.
• Oral complaints are documented upon receipt.
• Complaints are evaluated to determine whether the complaint is a
reportable event under Medical Device Reporting.
• All complaints are reviewed and evaluated to determine whether an
investigation is necessary. When no investigation is necessary, a record is
maintained that includes the reason no investigation was conducted and the
name of the individual responsible for the decision to not investigate.
• Any complaint involving the possible failure of a device, labeling or
packaging to meet any specifications is reviewed, evaluated and investigated
unless an investigation for a similar complaint was performed.
• Any complaint that represents a reportable event under 21 CFR 803 is
promptly reviewed, evaluated and investigated. These complaints are clearly
identified. The investigation record includes a determination of whether the
device failed to meet specifications, whether the device was being used for
treatment or diagnosis and the relationship, if any, of the device to the reported
incident or adverse event.

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8.3 MONITORING AND MEASUREMENT CONTINUED
• Records of investigation are maintained and include the name of the
device; the date the complaint was received; any device identification(s) and
control number(s) used; the name, address and phone number of the
complainant; the nature and details of the complaint; the dates and results of the
investigation; any corrective action taken; any reply to the complainant.
8.3.3 Monitoring and measurement of process
8.3.3.1 Suitable methods are applied for monitoring and measurement of the QMS
processes. These methods demonstrate the ability of the processes to achieve planned
results. When planned results are not achieved, corrective action is taken to ensure
product conformity.
8.3.4 Monitoring and measurement of product
8.3.4.1 Documented procedures are implemented to monitor and measure the
characteristics of the product to verify that product requirements are met. This is carried
out at appropriate stages of the product realization process in accordance with the
planned arrangements. Evidence of conformity with the acceptance criteria is maintained
and records indicate the person(s) authorizing release of the product. Product release
does not proceed until the planned arrangements are satisfactorily completed.
8.3.4.2 Documented procedures are established and maintained for identifying valid
statistical techniques for establishing, controlling, and verifying the acceptability of
process capability and product characteristics.
8.3.4.3 Quality plans will be developed for each finished component designed and/or
manufactured by Exsurco Medical and based on valid statistical rationale. Documented
procedures are established and maintained to ensure that sampling methods are adequate
for their intended use and to ensure that when changes occur the Quality plans are
reviewed. All such activities are documented.
8.3.4.4 The acceptance status of devices and components will be identified throughout
the manufacturing, packaging, labeling, storage and distribution to ensure the only
product that has met all of the criteria established in the quality plan have been met prior
to distribution or use. The status of devices returned for servicing will be similarly
identified until accepted and returned to the customer.
8.3.4.5 Records of monitoring and measurement activities will be maintained as part of
the device history record and will include the activities performed, the date when the
activity took place, the results of the activity, the signature of the person conducting the
activities, the person(s) authorizing release of product, and, when appropriate, the
equipment used for those activities.
8.4 CONTROL OF NONCONFORMING PRODUCT
8.4.1 Product
8.4.1.1 Documented procedures are implemented to ensure that product which does not
conform to product requirements is identified and controlled to prevent its unintended
use, release, or delivery. The procedures also address evaluation, segregation and
disposition. The controls and related responsibilities for dealing with nonconforming
product are defined.
8.4.1.2 The evaluation of nonconformance includes a determination of the need for an
investigation and notification of the persons or organization responsible for the
nonconformance.

Page 19 of 26
8.4 CONTROL OF NONCONFORMING PRODUCT CONTINUED
8.4.1.3 Nonconforming product is processed in one of the following ways:
• Action is taken to eliminate the detected nonconformity.
• Authorization of use, release, or acceptance under concession is given
only when regulatory requirements are met with records of the personnel
authorizing the concession being maintained.
• Action is taken to preclude its original intended use or application.
8.4.1.4 Records of the nature of nonconformities and any subsequent actions taken,
including evaluations, investigations, dispositions and concessions obtained, are
maintained.
8.4.1.5 When nonconforming product is corrected, it is subjected to reverification to
demonstrate conformity to the requirements.
8.4.1.6 When nonconforming product is detected after delivery or use has started,
appropriate action is taken to the effects or potential effects of the nonconformity
8.4.1.7 If product is reworked one or more times, the rework process is documented
and subject to the same approval and authorization as the original work instruction. Prior
to authorization and approval, a determination of any adverse effects of the rework upon
the product is made and documented.
8.5 ANALYSIS OF QMS DATA
8.5.1 Documented procedures are implemented to determine, collect and analyze appropriate
data to demonstrate the suitability and effectiveness of the QMS and to evaluate if improvement
of the effectiveness of the QMS can be made. The data includes data which is generated as a
result of monitoring and measurement and from other relevant sources. The following
information will be collected and assessed, at a minimum;
• Customer feedback
• Conformity to product requirements
• Process performance and opportunities for preventive action, and
• Supplier performance
8.5.2 Data is analyzed and, where found to be outside pre-defined criteria, planned action is
taken to correct the problem and prevent any incorrect results from being reported.
8.5.3 Records of the results of analysis of data are maintained.
8.6 IMPROVEMENT
8.6.1 General
8.6.1.1 Exsurco Medical identifies and implements changes necessary to ensure and
maintain the continued suitability and effectiveness of the QMS through the use of the
quality policy, quality objectives, audit results, analysis of data, corrective and
preventive actions, and management review.
8.6.1.2 Documented procedures are established for the issue and implementation of
advisory notices. These procedures are capable of being implemented at any time.
8.6.1.3 Records of customer complaint investigations are maintained. If an
investigation determines that the activities outside the organization contributed to a
customer complaint, relevant information is exchanged between the organizations
involved.

Page 20 of 26
8.6 IMPROVEMENT CONTINUED
8.6.1.4 If a customer complaint is not followed by corrective and/or preventive action,
the reason is authorized and recorded.
8.6.1.5 Documented procedures are established to address notification to regulatory
authorities where national and regional regulations require notification of adverse events
that meet specified reporting criteria.
8.6.2 Corrective action
8.6.2.1 Documented procedures have been established and implemented to ensure that
appropriate actions to eliminate the cause of nonconformities is taken in order to prevent
recurrence.
8.6.2.2 The documented procedures define the requirements for:
• Reviewing nonconformities, including customer complaints and
quality audit findings.
• Conducting internal audits, to ensure departments are in compliance
with internal procedures, standards or regulations.
• Determining the causes of nonconformities.
• Evaluating the need for action to ensure that nonconformities do not
recur.
• Determining and implementing actions needed, including, if
appropriate, updating documentation.
• Recording all activities and the results of any investigation and action
taken.
• Reviewing corrective action taken and its effectiveness. If necessary,
internal audits are conducted to confirm effectiveness.
• Ensuring that information related to quality problems or
nonconforming product is disseminated to those directly responsible for
assuring the quality of the product or the prevention of the problems.
• Submitting relevant information on identified quality problems, as
well as corrective and preventive actions, for management review.
8.6.3 Preventive Action
8.6.3.1 Exsurco Medical determines actions to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions are appropriate
to the effects of the potential problems. A documented procedure has been established
and implemented to define the requirements for:
• Determining potential nonconformities and their causes.
• Evaluating the need for action to prevent occurrence of
nonconformities or opportunities for improvement.
• Determining and implementing actions needed.
• Recording the results of any investigation and action taken.
• Reviewing preventive action taken and its effectiveness

Page 21 of 26
APPENDIX A: QUALITY MANGEMENT SYSTEM PROCESS

Page 22 of 26
APPENDIX B: ORGANIZATIONAL CHART
This diagram is for reference only.

Refer to Exsurco document ORG-1_00001 Organizational chart as the official version.

Page 23 of 26
APPENDIX C: LIST OF PROCEDURES FOR REFERENCE
DOCUMENT ID DOCUMENT NAME
MNT-7_00001 Equipment Calibration and Preventative Maintenance
MNT-7_00002 Pest Control Program
MNT-7_00003 Equipment Relocation
EOP-4_00001 Wash Tank Set-Up and Tear Down
EOP-4_00002 Accu-Seal 5506
MVP-8_00001 Master Validation Plan (MVP)
ORG-1_00001 Organizational chart
QP-1_00001 Quality Policy
SAFETY-1_00001 General Safety
SAFETY-1_00002 Bloodborn Pathogens Exposure Control Plan
SAFETY-1_00003 Hazard Communication Program
SAFETY-1_00004 Lockout Tagout Policy
SOP-1_00001 External Audits
SOP-1_00002 Good Documentation Practices
Development, Approval, Issuance, Biennial Review, and
SOP-1_00003 Management of Procedures
SOP-1_00004 Job Descriptions
SOP-1_00005 Access and Distribution of Controlled Document Copies
SOP-1_00006 Sample Size Determination
SOP-1_00008 Employee Training
SOP-1-00009 Control of External Documents and References
SOP-1_00010 Management Review
SOP-1_00012 Internal Audits
SOP-1_00041 Risk Management
SOP-2_00014 Design & Development Plan
SOP-2_00015 Design Review
SOP-2_00016 Design Control
SOP-2_00017 Design Inputs
SOP-2_00018 Design Verification
SOP-2_00019 Design Validation
SOP-2_00020 Design Outputs

Page 24 of 26
DOCUMENT ID DOCUMENT NAME
SOP-2_00035 Design Changes
SOP-2_00036 Design Transfer
SOP-2_00037 Design History File
SOP-3_00013 Supplier Quality and Purchasing Controls
SOP-4_00011 Re-Work Procedure
SOP-4_00021 Manufacturing Environmental Controls
SOP-4_00022 General Warehouse Cleaning Procedures
SOP-4_00023 Cleanroom Guidelines
SOP-4_00024 Cleanroom Cleaning Procedure
SOP-4_00025 Non-Viable and Viable Particulate and Environmental Management
SOP-4_00026 In Process Production
SOP-4_00027 Identification and Traceability of Product
SOP-4_00028 Limited Shelf Life Products
SOP-4_00029 Labeling, Packaging, Handling, Storage, and, Distribution Controls
SOP-4_00045 Creating a Device History Record (DHR)
SOP-4_00046 Creating a Device Master Record (DMR)
SOP-5_00007 Non-Conforming Event (NCE)
SOP-5_00030 Complaint Handling
SOP-5_00031 Corrective and Preventive Action (CAPA)
SOP-5_00032 Health Hazard Evaluations
SOP-5_00034 Product, Corrections, Removals, Withdrawals and Stock Recoveries
SOP-5_00038 Regulatory Affairs Activities
SOP-6_00042 Service Repair Procedure
SOP-6_00042_POLICY-G01 Exsurco Service Policy
SOP-10_00047_ POLICY-G01 Customer Service and Sales Policy
SOP-10_00048 Contract Review of Standard Product(s)

Page 25 of 26
REVISION HISTORY
EFFECTIVE
REVISION DCR # DESCRIPTION AUTHOR
DATE
- N/A Initial Release 5-8-2013 Geoff Rapp
A N/A D0000653 –On File 7-15-2013 Geoff Rapp
B N/A D0000653 –On File 5-13-2014 Geoff Rapp
C N/A D0000653 –On File 5-28-2014 Geoff Rapp
D N/A D0000653 –On File 6-10-2014 Geoff Rapp
E N/A D0000653 –On File 6-26-2014 Geoff Rapp
F N/A D0000653 –On File 7-29-2014 Geoff Rapp
G N/A D0000653 –On File 4-3-2015 Ed Hawkins
Complete re-write of Quality Manual to include U.S. QSR (21 CFR 820)
01 00291 requirements and removed ISO 9001 requirements. This includes new 11-15-2016 Swasita Saigal
nomenclature and revision method based on current system.

Page 26 of 26

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ISO 13485 U.S. QSR (21 CFR 820)