veridiam quality management systems manual

QM-1

QUALITY MANAGEMENT SYSTEMS

MANUAL

Revision 7

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TITLE DATE

Chief Executive Officer

Vice President, Engineering and

Quality

Management Representative /o

Director, Human Resources

Director, Operations, El Cajon WZ-7//O

hief Financial Officer ■/•

Regulatory Compliance Manager

Director, Operations, Oceanside

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TABLE OF CONTENTS

1. DOCUMENT REVISION HISTORY 5

2. INTRODUCTION 6

2.1 Purpose 6

2.2 Scope 7

Figure 1: Sequence and Interaction of the QMS 8

3. Terms and Definitions 9

4. QUALITY MANAGEMENT SYSTEM 10

4.1 General Requirements 10

4.2 Documentation Requirements 12

5. MANAGEMENT RESPONSIBILITY 15

5.1 Management Commitment 15

5.2 Customer Focus 15

5.3 Quality Policy 16

5.4 Quality Planning and Evaluation 17

5.5 Responsibility, Authority and Communication 17

5.6 Management Review 19

6. Resource Management 20

6.1 Provision of Resources 20

6.2 Human Resources 20

6.3 Infrastructure 21

6.4 Work Environment 22

7. Product Realization 23

7.1 Planning of Product Realization 23

7.2 Customer-related Processes 25

7.3 Design 27

7.4 Purchasing 27

7.5 Production Provision 31

7.6 Control of Monitoring and Measuring Devices 37

8. MEASUREMENT, ANALYSIS AND IMPROVEMENT 38

8.1 General 38

8.2 Monitoring and Measurement 39

8.3 Control of Nonconforming Product 44

8.4 Analysis of Data 46

8.5 Improvement 47

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APPENDIX A: QMS Support and Implementation 50

APPENDIX B: Structure of Documentation Used in QMS 51

APPENDIX C: Veridiam Organizationai Chart 53

APPENDIX D: Veridiam Functional Organization and Responsibilites 54

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DOCUMENT REVISION HISTORY

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1. INTRODUCTION

1.1 Purpose

1.1.1 This document has been prepared to describe the Quality

management system in place at Veridiam. It provides policy and

guidelines for all processes related to product provided by Veridiam

to its customers.

1.1.2 This "Quality Management System Manual" is the top level of a

multi-tiered structure, and is organized along the lines of ISO 9001,

AS9100, ISO 13485 and NQA-1. While this Quality Management

Systems Manual is referred to as the "Quality Manual", the details

for implementation of policies and guidelines are provided in lower

tiered documents such as procedures and work instructions.

1.1.2.1 Separate documents, QM-1 Supplement and QM-2

Supplement, list each lower tiered documents

associated with the applicable sections of this Quality

Manual. These supplemental documents may be

revised independently of this Quality Manual

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1.2 Scope

1.2.1 The scope of the work performed at Veridiam is fabrication and

assembly of specialty alloys that serve the medical, aerospace,

commercial and nuclear industries.

1.2.2 Veridiam's Quality management system encompasses several

regulatory requirements and standards that include:

a. ISO 9001:2008: "Quality Management System

Requirements,"

b. CAN/CSA ISO 13485:2003: "Medical Devices - Quality

Management Systems - Requirements for Regulatory

Purposes,"

c. AS 9100C: "Quality Systems-Aerospace - Model for

Quality Assurance in Design, Development, Production,

Installation and Servicing."

d. 10CFR 50, Appendix B: "Quality Assurance Criteria for

Nuclear Power Plants and Fuel Reprocessing Plants,"

e. ASME NQA-1: 2008: "Quality Assurance Requirements for

Nuclear Facility Applications,"

f. 10CFR21: 2005: "Reporting of Defects and Noncompliance'

g. Ordinance No. 169, Ministerial Ordinance on Standards for

Manufacturing Control and Quality Control for Medical

Devices and In-vitro Diagnostic Reagents.

1.2.3 Exclusion: Veridiam's Quality Management System does not

address the Design requirements (reference AS9100, ISO 9001,

ISO 13485 and 10CFR50 Appendix B).

1.2.4 Not Applicable: The following are not performed at Veridiam and

are not applicable to the Quality management system:

a. Test Control

b. Installation and Servicing activities

c. Sterilization

d. Agents, distributor and consignee requirements

e. Control of service operations

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Figure 1: The Sequence and Interaction of the Quality Management System

Processes

Marketing

Sales

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Support Processes

Core Processes

Planning of

Product

Reaction

7.1

Purchasing

7 A

■Production

7.5.2

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7.4.3; 8.2 4

Handling,

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"Performance data maintained

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Terms and definitions

3.1 Throughout the text of this Quality Manual, terms and definitions given in

ISO 9000 apply.

3.2 Special Requirements: those requirements identified by the customer or

determined by the organization to have high risks to being achieved.

Such requirements are typically subject to the risk management process.

3.3 Critical items: Items that have a significant effect on the product

realization and use of the product, including safety, performance, fit,

function, producibifity, service life—all which may require specific actions

to ensure they are adequately managed.

3.4 Key Characteristic: An attribute or feature whose variation has a

significant effort on product fit. form, function, performance, service life oi

producibility, that requires specific actions for the purpose of controlling

variation.

3.5 Medical Device: Any instrument, apparatus, implement, machine,

appliance, implant intended to be used alone or in combination, for human

beings for one or more of the following purposes:

a. diagnosis, prevention, monitoring, treatment or alleviation of

disease,

b. diagnosis, monitoring, treatment, alleviation of or compensation of

an injury,

c. investigation, replacement, modification, or support of the anatomy

of a physiological process,

d. supporting or sustaining life,

e. control of conception,

f. disinfection of medical devices, and,

g. providing information for medical purposes by means of in vitro

examination of specimens derived from the human body.

3.6 Advisory Notice: A notice issued by the organization subsequent to the

delivery of a medical device. An advisory notice provides information

regarding the use or modification of the medical device, the return of the

medical device to the organization, or the destruction of the medical

device.

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3.7. Responsible Engineering Manager: Also known as the "Management

Representative".

3.8 Marketing Authorization Holder: Also known as the "Customer".

QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

4.1.1 Veridiam has established, documented, implemented, and

continues to maintain a Quality management system (QMS). The

effectiveness of the QMS is maintained in accordance with

International Standards and other documents that are shown in the

Scope section of this Quality Manual.

4.1.2 Application and responsibility for QMS processes: The CEO is

responsible for overall implementation of the QMS at Veridiam.

Responsibilities of individual managers and their departments for

implementing and supporting QMS processes are shown in

Appendix A, QMS Support and Implementation

4.1.3 Veridiam's guality management system also addresses customer

and applicable regulatory quality management system

requirements. Veridiam performs the following:

a. determines the processes needed for the quality

management system and their application throughout the

organization,

b. determines the sequence and interaction of these processes

as seen in Figure 1, The Sequence and Interaction of the

Quality Management System Processes,

c. determines criteria and methods needed to ensure that

both the operation and control of these processes are

effective,

d. ensures the availability of resources and information

necessary to support the operation and monitoring of these

processes,

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e. monitors, measures and analyzes these processes,

f. implements actions necessary to achieve planned results,

continual improvement, and maintain the effectiveness of

these processes,

g. when Veridiam chooses to outsource any process that

affects product conformity to requirements, the organization

ensures control over such processes, and

h. the type and extent of control of outsourced processes

are identified within the supplier management systems and

contractual agreements.

NOTE 1: Processes needed for the Quality management system

referred to above include processes for management activities,

provision of resources, product realization, measurement, analysis

and improvement.

NOTE 2: An outsourced process is a process that the organization

needs for its quality management system and which the

organization chooses to have performed by an external party.

NOTE 3: Ensuring control over outsourced processes does not

absolve Veridiam of the responsibility of conformity to all

customer, statutory and regulatory requirements. The type and

extent of control applied to outsourced processes can be influenced

by factors such as:

a. the potential impact of the outsourced process on the

organization's capability to provide product that conforms to

requirements,

b. the degree to which the control for the processes is shared,

c. the capability of achieving the necessary control through the

application of purchasing processes.

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4.2 Documentation Requirements

4.2.1 Activities affecting quality of product and compliance to the quality

management system are prescribed by and performed in

accordance with documents such as instructions, procedures,

drawings, etc. These documents are commensurate in detail with

the complexity of the activity and the degree of control required,

and include:

a. documented statements of a quality policy and quality

objectives,

b. a quality manual,

c. documented procedures and records as required by

International Standards and customer requirements,

d. documents, including records determined by the

organization to be necessary to ensure the effective

planning, operation and control of its processes,

e. quality system requirements imposed by applicable

regulatory authorities,

f. when International Standards, regulatory and customer

requirements specifies that a requirement, procedure,

activity or special arrangement be documented, it is

implemented and maintained.

g. for each type or model of medical device, Veridiam

establishes and maintains a file either containing or

identifying documents defining product specifications and

Quality management system requirements. These

documents define the complete manufacturing process.

NOTE 1; Where the term "documented procedure" appears in this

Quality Manual, the procedure is established, documented,

implemented and maintained.

NOTE 2: A single document may address the requirements for one

or more procedures. A requirement for a documented procedure

may be covered by more than one document.

NOTE 3: Veridiam determines the form and medium best suited to

documentation requirements.

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4.2.2 Quality Manual: Veridiam has established and maintains a Quality Manual that includes:

a. the scope of the Quality management system, including

details of and justification for any exclusion and/or non-

application,

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. This is accomplished within

each section of this manual,

4.2.2.1 Separate documents, QM-1 Supplement and QM-2

Supplement, list applicable procedures that support

the Quality Manual and the quality management

system processes.

4.2.3 Control of Documents: Documents required by the quality

management system are controlled in the following manner:

a. approve documents for adequacy prior to issue,

b. review, update, and as necessary, re-approve documents,

c. ensure that changes and the 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 determined by the

organization to be necessary for the planning and operation

of the quality management system are identified and their

distribution controlled,

g. identify and maintain status of controlled documents,

to ensure that changes and the current revision status of

documents are identified,

h. prevent the unintended use of obsolete documents, and to

apply suitable identification to them if they are retained for

any purpose,

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i. ensure that changes to documents are reviewed and

approved either by the original approving function or another

designated function which has access to pertinent

background information upon which to base its decisions,

j. defines the period for which at least one copy of

obsolete controlled documents is retained. This period

ensures that documents to which medical devices have been

manufactured and tested are available for at least the

lifetime of the medical device as defined by Veridiam, but

not less than the retention period of any resulting record, or

as specified by relevant regulatory requirements,

k. personnel have access to QMS documentation and are

aware of relevant procedures, and

I. customer and/or regulatory authority representatives have

access to non-proprietary QMS documentation.

NOTE: Records are a special type of document and are controlled in

accordance with section 4.2.4.

4.2.4 Control of Records: Records established to provide evidence of

conformity to requirements and of the effective operation of the

quality management system are controlled. A documented

procedure defines the controls needed for the identification,

storage, protection, retrieval, retention and disposition of records.

Controls include:

a. records remain legible, readily identifiable and retrievable

b. records are retained for a period of time at least equivalent

to the lifetime of the medical device as defined by Veridiam,

but not less than two years from the date of product release

by Veridiam or as specified by relevant regulatory

requirements, and

c. records are available for review by customers and regulatory

authorities in accordance with contract or regulatory

requirements.

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MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.1.1 Top management provides evidence of its commitment to the

development and implementation of the Quality management

system and continually improving its effectiveness by:

a. Communicating to Veridiam employees the

importance of meeting customer as well as statutory and

regulatory requirements,

b. establishing the quality policy,

c. establishing quality objectives,

d. conducting management reviews,

e. ensuring the availability of resources, and

f. ensuring that those responsible for verifying quality

have sufficient authority, direct access to

management, organizational freedom, and the access to

work to perform their function.

Note: In some cases, the "customer" may be referred to as the "marketing

authorization holder and other bodies receiving the products".

5.1.2 A description of the functional organizations and their

responsibilities are depicted in Appendix D.

5.2 Customer Focus

5.2.1 Top management ensures that customer requirements are

determined and are met with a goal of enhancing customer

satisfaction.

5.2.2 Top management ensures product conformity and on-time delivery

performance are measured and that appropriate action is taken if

planned results are not, or will not be achieved.

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5.3 Quality Policy

5.3.1 Veridiam has an established Quality Policy. Top management

ensures that the quality policy:

a. is appropriate to the purpose of Veridiam,

b. includes a commitment to comply with requirements,

c. includes a commitment to continually improve and

maintain the effectiveness of the quality management

system,

d. provides a framework for establishing and reviewing quality

objectives,

e. communicated and understood within Veridiam,

f. is reviewed for continuing suitability, and

g. is based on customer focus

5.3.2 The Veridiam Quality Policy is as follows:

We are committed to total customer satisfaction

through compliance to requirements, maintenance of

the quality management system and continuous

improvement of our processes, products and

services.

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5.4 Quality Planning and Evaluation

5.4.1 Quality Objectives: Top management ensures that quality

objectives, including those needed to meet requirements for

product, are established at relevant functions and levels within

Veridiam. The quality objectives are measurable and consistent

with the quality policy.

5.4.2 Quality Management System Planning: Top management ensures

that:

a. planning of the quality management system is carried out

to meet the requirements of the quality objectives and the

general requirements to establish, document and

maintain the quality management system,

b. the integrity of the quality management system is maintained

when changes to the quality management system are

planned and implemented, and

c. actions are taken to implement improvements to the quality

management system as soon as practical.

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority: Top management ensures that

responsibilities and authorities are defined, documented and

communicated within the organization.

5.5.1.1 Top management establishes the interrelation of all

personnel who manage, perform and verify work affecting

quality, and ensures the independence and authority

necessary to perform these tasks.

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5.5.2 Management representative: Top management appoints a member

of the organization's management who, irrespective of other

responsibilities has the responsibility and authority that includes:

a. ensuring that processes needed for the quality management

system are established implemented and maintained,

b. reporting to top management on the performance of the

Quality management system and any need for improvement,

c. ensuring the promotion of awareness of regulatory and

customer requirements throughout Veridiam,

d. promoting awareness among Veridiam employees of the

Quality Policy and the requirement for customer focus in all

activities,

e. has organizational freedom and unrestrictive access to top

management to resolve matters pertaining to quality

management, and

f. serves as the Veridiam point of contact when liaison with

external parties on matters relating to the quality

management system is required.

5.5.3 Internal communication: Management ensures that appropriate

communication processes are established. The organization

ensures that communication takes place regarding the

effectiveness of the quality management system by one or more of

the following means:

a. format periodic reviews of the quality management system,

b. communication of quality objectives and the status of their

implementation in distributed reports,

c. periodic all-employee meetings held by top management,

and

d. periodic meetings between department managers and the

employees in their departments.

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5.6 Management Review

5.6.1 General: Top management reviews Veridiam's quality

management system in accordance with documented procedures.

Management reviews:

a. are performed at planned intervals to ensure its continuing

suitability, adequacy and effectiveness,

b. assess opportunities for improvement and the need for

changes to the quality management system, including the

quality policy and quality objectives, and.

c. are documented in management review presentations and

minutes, including actions to be taken.

5.6.2 Review input to management review includes information from:

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,

g. recommendations for improvement, and

h. new or revised regulatory requirements.

5.6.3 Review output from the management review includes any decision

and actions related to:

a. improvements needed to maintain the effectiveness of the

quality management system and its processes,

b. improvement of product related to customer requirements,

and,

c. resource needs.

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RESOURCE MANAGEMENT

6.1 Provision of Resources

6.1.1 Management determines and provides the resources needed:

a. to implement the Quality management system and to

continually improve and maintain its effectiveness,

b. to meet regulatory and customer requirements,

c. to achieve Veridiam business and quality objectives, and

d. to enhance customer satisfaction by meeting or exceeding

customer expectations.

6.2 Human Resources

6.2.1 General: Personnel who perform work affecting conformity to

product requirements are competent on the basis of appropriate

education, training, skills and experience.

NOTE: Conformity to product requirements can be affected directly or

indirectly by personnel performing any task within the quality management

system.

6.2.2 Competence, Training and Awareness. The organization:

a. determines the necessary competence for personnel

performing work affecting conformity to product quality,

b. where applicable, assesses the competence of employees

and provides training or other takes other actions to achieve

the necessary competence,

c. evaluates the effectiveness of the actions taken to establish

and maintain employee competence,

d. ensures that personnel are aware of the relevance and

importance of their activities and how they contribute to the

achievement of the quality objectives,

e. generates and maintains appropriate records of education,

training, skills and experience, and

f. establishes documented procedures for identifying training

needs based on regional or national regulations if required.

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6.2.3 Veridiam ensures that ail employees receive initial and periodic

training in quality management system procedures applicable to

their job function.

6.3 Infrastructure

6.3.1 Veridiam determines, provides, and maintains 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, communication or

information systems), and

d. pest control (such as insects or rodents) is provided on an

as-needed basis in manufacturing and administrative areas.

6.3.2 Documented procedures outline requirements for maintenance

activities, including their frequency, when such activities or lack

thereof can affect product quality.

6.3.3 Hardware and software suitable for minimizing variation while

ensuring product conformity is provided and maintained. A

preventive maintenance program is implemented to assure that

equipment performs reliably within design parameters. Software

quality assurance procedures ensure that software is protected

from modification without proper authorization and testing.

6.3.4 Records of maintenance activities and results are maintained.

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6.4 Work Environment

6.4.2 Veridiam determines the requirements for, and manages the work

environment needed to achieve conformity to product requirements.

6.4.3 Veridiam maintains a safe and efficient work environment for its

employees. The following requirements apply:

a. documented requirements for health, cleanliness and

clothing of personnel if contact between such personnel and

the product or work environment could adversely affect the

quality of the product,

b. where the work environment conditions can have an adverse

effect on product quality, Veridiam has established

documented requirements for the work environment

conditions and documented procedures or work instructions

to monitor and control these work environment conditions.

Factors to be considered include temperature, humidity,

lighting, cleanliness, protection from electrostatic discharge,

etc.,

c. all personnel who are required to work temporarily under

special environmental conditions within the work

environment are appropriately trained or supervised by a

trained person,

d. if appropriate, special arrangements are established and

documented for the control of contaminated or potentially

contaminated product in order to prevent contamination of

other product, the work environment, or personnel, and

e. all necessary actions are taken to minimize the use and

generation of hazardous materials and to ensure full

compliance with applicable environmental regulations.

NOTE: The term "work environment" relates to those conditions under

which work is performed including physical, environmental and other

factors such as noise, temperature, humidity, lighting or weather.

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6.4.4 Safety Program. Veridiam has made appropriate provisions for the

safety of its employees through:

a. actively managing the work environment in order to provide

a safe, efficient work place that maximizes employee

effectiveness, and

b. a plant-wide safety program that focuses on such factors as

safety guarding, fire hazards, trip hazards, and electrical

safety has been established. When required, special safety

programs (e.g., overhead lifting safety and forklift safety) are

implemented and managed.

Product Realization

7.1 Planning of Product Realization: Veridiam plans and develops the

processes needed for the manufacture of product in accordance with

documented procedures. Planning of product realization is consistent with

the requirements of the other processes of the quality management

system. The organization determines as appropriate:

a. quality objectives and requirements for the product (see Note 1),

b. the need to establish processes, documents, and provide resources

specific to the product,

c. required verification, validation, monitoring, inspection and test

activities specific to the product and the criteria for product

acceptance,

d. records needed to provide evidence that the realization processes

and resulting product meet requirements,

e. configuration management appropriate to the product,

f. resources to support the use and maintenance of the product (as

applicable),

g. cleanliness to specified levels and the removal of process agents,

and,

h. regulatory requirements for the product (as applicable).

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NOTE 1: Quality objectives and requirements for the product include

consideration of aspects such as:

• product and personnel safety

• reliability, availability and maintainability

• producibility and inspectability

• suitability of parts and materials used in the product

• selection and development of embedded software, and

• recycling or final disposal of the product at the end of its life

NOTE 2: A document specifying the processes of the quality

management system {including the product realization processes) and the

resources to be applied to a specific product, project or contract can be

referred to as a "quality plan."

7.1-2 Project Management: As appropriate to the organization and the

product, Veridiam plans and manages product realization in a

structured and controlled manner to meet requirements at

acceptable risk. This is accomplished within known resource and

schedule constraints.

7.1.3 Risk Management: Veridiam has established processes for

managing risk to the achievement of applicable requirements. Risk

management includes:

a. assignment of responsibilities for risk management,

b. definition of risk criteria (e.g., likelihood, consequences, risk

acceptance),

c. identification, assessment and communication of risks

throughout product realization,

d. identification, implementation and management of actions to

mitigate risks that exceed the defined risk acceptance

criteria,

e. acceptance of risks remaining after implementation of

mitigating actions,

f. additional assessments when requirements change, and

g. documentation of assessments

NOTE: Documented risk analyses are performed for product as required

by International Standards or specific customer requirements.

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7.1.4 The output of planning for product realization are in a form suitable

forVeridiam's method of operations, as applicable:

a. sequence of manufacturing operations (traveler),

b. a bill of material,

c. the establishment of process controls and development of

control plans where key characteristics have been identified

by the customer,

d. the identification of in-process verification points when

adequate verification of conformance cannot be performed

at a later stage of realization,

e. the provision for tooling and measuring equipment so that

variable measurements can be taken whenever possible,

(particularly for key characteristics identified by the

customer),

f. identification of special processes and related qualification

requirements,

g. a means to record completion of manufacturing operations,

and to collect data, and,

h. requirements for product certification.

7.2 Customer-Related Processes

7.2.1 Determination of requirements related to the product: Veridiam

reviews the requirements related to the product in accordance with

documented procedures. These reviews are conducted prior to the

commitment to supply a product to the customer, including:

a. requirements specified by the customer, including product

requirements and the requirements for delivery, and post-

delivery activities,

b. requirements not stated by the customer but necessary for

specified or intended use (where known),

c. statutory and regulatory requirements applicable to the

product,

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d. any additional requirements considered necessary, and

e. internally-generated requirements are determined and can

be met.

NOTE: Post delivery activities include actions under warranty provisions

or contractual obligations.

7.2.2 Review of requirements related to the product: Veridiam performs

reviews prior to the commitment to supply a product to the

customer (e.g. acceptance of contracts or orders, acceptance of

changes to contracts or orders) and ensures that:

a. product requirements are defined and documented,

b. contract or order requirements differing from those

previously expressed are resolved,

c. the organization has the ability to meet the defined

requirements,

d. special requirements of the product are determined, and

e. risks (e.g., new technology, short delivery time scale) have

been identified and evaluated.

7.2.3 Where the customer provides no documented statement of

requirement, the customer requirements are confirmed by Veridiam

before acceptance.

7.2.4 Where product requirements are changed, Veridiam ensures that

relevant documents are amended and that relevant personnel are

made aware of the changed requirements.

7.2.4.1 Records of the results of the review and actions

arising from the review are documented and

maintained.

NOTE; In some situations such as Internet sales, a forma! review

is impractical for each order. The review may cover relevant

product information such as catalogs or advertising material.

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7.2.5 Customer Communication and Satisfaction: Veridiam determines

and implements effective arrangements for communicating with

customers. These activities include:

a product information,

b inquiries, contracts or order handling, including

amendments,

c customer feedback, including customer complaints, and

d. advisory notices.

7.2.6 As one of the measurements of the performance of the Quality

management system, the organization monitors and reports

information relating to customer perception as to whether Veridiam

has met customer requirements, and has taken appropriate actions.

7.3 Design and Development

This section is excluded as Veridiam neither designs nor develops

products as defined in International Standards or customer requirements.

All product manufactured by Veridiam is to customer design and

specifications.

7.4 Purchasing

7.4.1 Purchasing process: Veridiam has established documented

procedures to ensure that purchased product conform to specified

purchase requirements. The type and extent of control applied to

the supplier and the purchased product is dependant upon the

effect of the purchased product on subsequent product realization

or the final product. Supplier controls include:

a. evaluation and selection of suppliers in accordance with

their ability to supply product or meet requirements. In some

cases, suppliers must meet specific quality management

system requirements.

b. criteria for selection, evaluation and re-evaluation of

suppliers is established in documented procedures.

c. the maintenance of an Approved Supplier List (ASL) that

includes approval status and the scope of the approval

(typically by commodity or service),

Page: 27 of 57



d. the periodic review of supplier performance. The results of

these reviews are used as a basis for establishing the levels

of control needed to ensure conformity to product or service

requirements,

e. necessary actions to be taken when dealing with suppliers

who do not meet requirements is defined,

f. when required, Veridiam and its suppliers use customer-

approved special process sources,

g. the process, responsibilities and authority for supplier

evaluation and approval, changes of approval, and the

status and conditions for controlled use of suppliers is

defined,

h. the risk and mitigation actions for use of suppliers are

determined, and

i. records of the results of supplier selection and evaluation are

documented as well as any necessary actions arising from

the evaluations.

NOTE 1: Veridiam is responsible for the conformity of all products

purchased from suppliers, including product from sources directed

by the customer.

NOTE 2: One factor that can be used during supplier selection and

evaluation is supplier quality data obtained from objective and

reliable external sources (such as an accredited quality

management system, certification bodies or government or

customer approvals).

Use of this data represents one component of Veridiam's supplier

control process. The organization remains responsible for the

verification of purchased product to ensure that it meets specified

purchase requirements

7.4.2 Purchasing information: purchasing information describes the

product or service to be purchased, including where appropriate:

a. requirements for approval of product, procedures, processes

and equipment,

b. requirements for qualification of personnel,

c. quality management system requirements,

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d. the identification and revision status of specifications,

drawings, process requirements, inspection/verification

instructions and other relevant data,

e. requirements for test, inspection, verification (including

production process verification),

f. use of statistical techniques for product acceptance, related

instructions for acceptance by the organization and

applicable critical items including key characteristics,

g. requirements for test specimens for inspection/verification,

investigation or auditing,

h. requirements for the need of the supplier to:

• notify Veridiam of nonconforming product,

• obtain approval of nonconforming product disposition

• notify Veridiam of organizational changes such as

product/process changes, changes of suppliers, changes

of manufacturing facility move, and

• flow down to the supply chain applicable requirements

including customer requirements,

i. record retention requirements, and

j. the right of access by Veridiam, its customers and regulatory

agencies to applicable areas of all facilities, at any level of

the supply chain involved in the order and to all applicable

records.

7.4.3 Verification of purchased product: Veridiam has established and

implemented systems for inspection and/or other activities

necessary to ensure that product meets specified requirements

These systems include as applicable:

a. obtaining objective evidence of the quality of the material

from suppliers (e.g., accompanying documentation,

certification of conformity, test reports, statistical records,

process control data),

b. inspection and/or audit at supplier's premises,

c. review of the required documentation,

d. inspection of materials upon receipt,

e. delegation of verification to the supplier, or supplier

certification,

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f. purchased material is not used or processed until it has been

verified as conforming to specified requirements unless it is

conditionally released under positive recall procedures,

g. where Veridiam utilizes test reports to verify purchased

material, the data in those reports is acceptable per

applicable specifications. Veridiam periodically validates test

reports for raw material,

h. where Veridiam delegates verification activities to a supplier,

the requirements for delegation are defined and a register of

delegations maintained,

i. where Veridiam or its customer intends to perform

verification at the supplier's premises, Veridiam states the

intended verification arrangements and method of product

release in the purchasing information,

j. where specified in the contract, the customer or the

customer's representative is afforded the right to verify at

the supplier's premises and Veridiam's premises that

subcontracted product conforms to specified requirements,

k. verification by the customer is not used by Veridiam as

evidence of effective control of quality by the supplier and

does not absolve Veridiam or the supplier of the

responsibility to provide acceptable product, nor does it

preclude subsequent rejection by the customer,

I. where purchased product is released for production use

pending completion of all required verification activities, the

product is identified and recorded to allow recall and

replacement if the product is later found nonconforming, and

m. records of al! verification activities are maintained.

7.4.4 Veridiam ensures the adequacy of specified purchase requirements

prior to their communication to the supplier.

7.4.5 To the extent required for traceability, Veridiam maintains relevant

purchasing information and records.

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7.5 Production Provision

7.5.1 Control of production provision: Veridiam plans and carries out

production provision under controlled conditions. Processes are

performed under controlled conditions, so that quality is achieved

and maintained by those responsible for performing work.

Controlled conditions include, as applicable:

a. the availability of information that describes the

characteristics of the product,

b. the availability of documented procedures, documented

requirements, written work instructions and reference

materials and reference measurement procedures as

necessary,

c. the use of approved processes, equipment, tools, programs,

and materials,

d. the availability of monitoring and measuring devices or

equipment,

e. the implementation of monitoring and measurement plans,

f. the implementation of product release, delivery and post-

delivery activities,

g. the implementation of defined operations for labeling and

packaging,

h. accountability for all product during manufacture (e.g., parts

quantities, split orders, nonconforming product},

i. evidence that all fabrication and inspection operations have

been completed as planned or as otherwise documented

and authorized,

j. provision for the prevention, detection, and removal of

foreign material,

k. monitoring and control of utilities and supplies such as water,

compressed air, electricity and chemical products to the

extent they affect product quality,

I. criteria for workmanship, which shall be stipulated in the

clearest practical manner (e.g., written standards,

representative samples or illustrations), and

m. assignment of fabrication and inspection duties to qualified

individuals.

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7.5.2 Validation of processes for production: Veridiam validates

processes for production where the resulting output cannot be

verified through subsequent monitoring and measurement, and as

a consequence, deficiencies become apparent only after the

product is in use. These processes are often referred to as "special

processes." Validation demonstrates the ability of these processes

to achieve planned results by:

a. defined criteria for review and approval of processes.

b. approval of equipment and qualification of personnel.

c. use of specified methods and procedures,

d. requirements for records, and

e. revalidation as needed.

7.5.2.1 Control of Manufacturing Process Changes are

handled as follows:

a. the organization identifies and obtains

acceptance of changes that require customer

and/or regulatory authority approval in

accordance with contract or regulatory

requirements,

b. changes affecting processes, manufacturing

equipment, tools and programs are

documented. Procedures are available to

control their implementation,

c. Persons authorized to approve changes to

manufacturing processes are identified, and

d. the results of changes to manufacturing

processes are assessed to confirm that the

desired effect has been achieved without

adverse effects to product quality.

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7.5.2.2 Control of manufacturing equipment, tools and

computer programs is handled as follows:

a. manufacturing equipment, tools and programs

is safeguarded from deterioration at all times,

validated prior to use, and maintained and

inspected periodically according to

documented procedures, and

b. validation prior to manufacturing use includes

verification of the first article produced to the

design data/specification.

7.5.2.3 Control of Production—specific requirements for

cleanliness and contamination control-Veridiam

establishes documented requirements for cleanliness

of product if:

a. product is cleaned by the organization prior to

sterilization and/or its use, or,

b. product is supplied non-sterile to be subjected

to a cleaning process prior to sterilization

and/or its use, or,

c. product is supplied to be used non-sterile and

its cleanliness is of significance in use, or,

d- process agents are to be removed from

product during manufacture

7.5.2.4 Installation, servicing and particular requirements for

sterile medical devices per ISO 13485 are not

applicable, as Veridiam does not produce product

requiring installation, servicing or sterilization.

7.5.2.5 The organization establishes and maintains a record

for each batch of medical devices that provides

traceability and identifies the amount manufactured

and amount approved for distribution. Batch or lot

records are verified and approved. A batch can be a

single medical device.

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7.5.3 Identification and Traceability: As appropriate, the organization

identifies product status by suitable methods throughout product

realization. The organization has established procedures for

product identification that includes:

a. travelers, tags or other documents are maintained to ensure

product status through manufacture, inspection and other

measuring and monitoring activities,

b. status identification of product is maintained throughout

product realization and storage of the product to ensure that

only product that has passed the required inspections and

test (or released under an authorized concession) is

dispatched and used,

c. controls for the identification is maintained throughout the

product life,

d. the establishment of documented procedures to ensure that

medical devices and other products returned to Veridiam

are identified and distinguished from conforming product,

e. the establishment of documented procedures for traceability.

Such procedures define the extent of product traceability and

the records required,

f. for a given product, a sequential record of its manufacturing

is retrievable,

g. for an assembly, the identity of its components and those of

the next higher assembly to be traced,

h. provisions for the recording of the unique identification of the

product including heat lot and other lot numbers, and

i. identify the amount manufactured and approved for

distribution or sale.

NOTE: Configuration management at Veridiam is a means

by which identification and traceability can be maintained.

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7.5.3.1 Particular requirements for active implantable medical

devices and implantable medical devices are:

a. in defining the records required for traceability,

Veridiam includes records of all components,

materials and work environment conditions, if

these could cause the medical device not to

satisfy its specified requirements, and

b. requirements in ISO 13485 pertaining to

agents and distributors and consignees do not

apply, as Veridiam does not have agents,

distributors or consignees for implantable

medical devices.

7.5.4 Customer property: Veridiam exercises care with customer

property while it is under the organization's control or being used

by the organization. Veridiam:

a. identifies, verifies, protects and safeguards customer

property provided for use or incorporation into the product.

b. if any customer property is lost, damaged or otherwise

found to be unsuitable for use, the organization reports the

conditions to the customer, and records are maintained.

NOTE: Customer property can include intellectual property

and personal data.

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7.5.5 Preservation of product: Veridiam has controls in place to ensure

that product is preserved during internal processing and delivery

to the intended destination in order to maintain conformity to

requirements. As applicable, preservation includes:

a. identification, cleaning, handling, packaging, storage and

protection. Preservation also applies to the constituent parts

of a product,

b. controls for the prevention, detection and removal of foreign

objects,

c. special handling of sensitive products,

d. marking and labeling including safety warnings,

e. documented procedures or documented work instructions for

the control of product with a limited shelf life or requiring

special storage conditions. Such special storage conditions

also include stock rotation,

f. where applicable, special handling for sensitive products and

hazardous materials, and

g. where applicable, special handling tools and equipment {e.g.

lifting equipment) are utilized and controlled where

necessary to ensure safe and adequate handling. This

tooling and equipment is inspected and tested periodically or

prior to use as necessary to ensure satisfactory

performance.

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7.6 Control of Monitoring and Measuring Devices

7.6.1 The organization determines the monitoring and measurement to

be undertaken and the monitoring and measuring devices needed

to provide evidence of conformity of product to determined

requirements.

7.6.2 Documented procedures establish controls for monitoring and

measurement to ensure that such activities are carried out in a

manner that is consistent with the monitoring and measurement

requirements.

7.6.3 Where necessary to ensure valid results, measuring equipment is:

a. calibrated or verified {or both) at specific intervals, whenever

the accuracy of the equipment is suspect, 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 verification is

recorded,

b. adjusted or re-adjusted as necessary,

c. has unique identification in order to determine its calibration

status,

d. is safeguarded from adjustments that would invalidate the

measurement result,

e. protected from damage and deterioration during handling,

maintenance and storage,

f. registered in a system for controlling monitoring and

measurement devices, and

g. has assigned specific requirements for calibration, including

details of equipment type, unique identification, location,

frequency of checks, check method and acceptance criteria,

7.6.4 Veridiam assesses and records the validity of the previous

measuring results when the equipment is found not to conform to

requirements. The organization takes appropriate action for the

equipment and any product affected.

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7.6.5 A documented process is in place for the recall of monitoring and

measuring equipment requiring calibration or verification.

7.6.6 When used in the monitoring and measurement of specified

requirements, the ability of computer software to satisfy the

intended application is confirmed. This is undertaken prior to initial

use and reconfirmed as necessary.

NOTE: Confirmation of the ability of computer software to satisfy the

intended application typically includes its verification and

configuration management to maintain its suitability for use.

7.6.7 Records of the results of calibration and verification are maintained.

8 MEASUREMENT. ANALYSIS AND IMPROVEMENT

8.1 General: Veridiam plans and implements the monitoring, measurement,

analysis and improvement processes needed to:

a. demonstrate conformity to product requirements,

b. ensure conformity of the quality management system, and

c. continually improve the effectiveness of the quality management

system and processes (both product and administrative).

8.1.1 Methods to be used, including statistical techniques and the extent

of their use, are prescribed where applicable.

8.1.2 According to the nature of the product and depending on specified

requirements, statistical techniques can be used to support:

a. process control,

b. selection of inspection of key characteristics,

c. process capability measurements,

d. statistical process control,

e. design of experiment,

f. inspection, and

g. failure mode, effect and criticaiity analysis.

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8.2 Monitoring and Measurement

8.2.1 Customer satisfaction and feedback: As one of the measurements

of the performance of the quality management system, Veridiam

monitors information relating to whether it has met customer

requirements. Veridiam has implemented a documented procedure

for a feedback system and to provide early warning of quality

problems. The process also provides for input into the corrective

and preventive action systems as applicable.

8.2.1.1 Monitoring customer perception includes obtaining

input from customers from sources such as:

a. customer satisfaction surveys,

b. customer performance data for product quality

and on-time delivery,

c. customer complaints and claims,

d. corrective action requests,

e. opinion surveys,

f. compliments, and

g. lost business analysis.

NOTE: Customer satisfaction may also be determined based on

the perceptions of Veridiam employees who are in contact with

customers on a regular basis.

8.2.1.2 Plans are developed and implemented for customer

satisfaction improvement that addresses deficiencies

noted in evaluations and perceptions. The

effectiveness of the results is assessed.

NOTE: If national or regional regulations require the organization

to gain experience from the post-production phase, the review of

this experience is part of the feedback system.

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8.2.2 Internal audits are conducted at planned intervals to determine

whether the quality management system is effectively implemented

and maintained and meets the requirements of the International

Standards, and regulatory requirements cited in the Scope of this

Quality Manual.

8.2.2.1 The internal audit program is documented and

planned, taking into consideration:

a. the status and importance of the processes

and areas to be audited

b. results of previous audits,

c. plans for audit criteria, scope, frequency and

methods,

d. the selection of auditors and the conduct of

audits to ensure objectivity and impartiality

(auditors do not audit their own work),

e. a documented procedure to define the

responsibilities and requirements for planning

and conducting audits,

f. establishing records,

g. reporting audit results,

h. responsibility for necessary corrections and

corrective actions to be taken without undue

delay to eliminate detected nonconformities

and their causes,

i. follow up activities that include the verification

of actions taken and the reporting of

verification results, and

j. the need for the maintenance of records of

audits and their results.

NOTE: Planned arrangements include customer contractual requirements.

8.2.3 Monitoring and measurement of processes: Veridiam monitors and

measures the characteristics of the quality management system

processes. These methods demonstrate the ability of the

processes to achieve planned results.

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8.2.3.1 Consideration is given to the type and extent of

monitoring and measurement in relationship to its

impact on the conformity to product requirements and

on the overall effectiveness of the quality

management system.

8.2.3.2 Managers responsible for specific quality

management system processes apply suitable

methods for monitoring and, where applicable,

measurement of those processes. These methods

demonstrate the ability of the processes to achieve

planned results.

8.2.3.3 When planned results are not achieved, remedial and

corrective action are taken, as appropriate.

8.2.3.4 In the event of a process nonconformity,

the following occurs:

a. appropriate actions are taken to address the

nonconforming process,

b. an evaluation is performed to determine if the

process nonconformity has resulted in product

nonconformity,

c. an evaluation is performed to determine if the

process nonconformity is limited to a specific

case or whether it could have affected other

processes or product, and

d. identify and control of any nonconforming

product is maintained.

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8.2.4 Monitoring and measurement of product: Veridiam monitors and

measures the characteristics of the product to verify that product

requirements have been met. Documented procedures for

monitoring and measurement of product include:

a. planning and work instructions ensure that monitoring and

measurement are carried out at appropriate stages of the

product realization process and are completed before the

product is released for shipment,

b. the release of product to the customer does not proceed until

the planned arrangements have been satisfactorily

completed,

c. product shipped to customers conforms to the customer's

requirements,

d. records of actions taken to confirm conformity with the

acceptance criteria are maintained,

e. when key characteristics have been identified by the

customer, they are monitored and controlled,

f. when sampling inspection is used as a means of product

acceptance, the plan is statistically valid and appropriate for

use. If required, the plan is submitted for customer approval.

When specifically required by contract, the plan precludes

the acceptance of lots whose samples have known

nonconformities,

g. evidence of conformity with the acceptance criteria is

maintained,

h. test records show actual inspection/test data when required

by specification of acceptance test plan,

i. only qualified persons perform inspection for acceptance,

j. records indicate the person(s) authorizing the release of

product for delivery to the customer,

k. records of the identity of personnel who perform inspection

and testing is maintained, and

I. all documents required to accompany the product are

present at delivery.

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8.2.4.1 Special requirements apply to acceptance inspections of

nuclear safety-related products. These special requirements

state that acceptance inspections are performed by qualified

inspectors that are:

a. assigned to Quality Systems, or,

b. assigned to Operations, provided the inspections are

subject to documented surveillance by Quality

Systems inspectors, to ensure accuracy and

impartiality of results, and

c. acceptance inspections are performed by persons

other than those who performed or directly supervised

the work inspected. The following exceptions

apply:

• a person who participated in fabrication of the

product may perform an acceptance inspection,

provided his/her work did not directly influence

thecharacteristic(s) being inspected.

• acceptance inspections which are not susceptible

to inspector influence may be performed by the

same person who performed the work being

inspected.

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8.3 Control of Nonconforming Product

8-3-1 Veridiam has measures in place to ensure that product that does

not conform to product requirements is identified and controlled to

prevent its unintended use or delivery.

8.3.2 The controls and related responsibilities and authorities for dealing

with nonconforming product, and also with nonconforming material

received from vendors is documented, implemented and

maintained. These controls include:

a. taking action to eliminate the detected nonconformity

b. by authorizing its use, release or acceptance under

concession by a relevant authority or customer,

c. taking action to preclude its original intended use or

application, and

d. taking actions appropriate to the effects, or potential effects

of the nonconforming product detected after delivery or use.

8.3.3 Nonconforming material is separated from conforming material

physically and/or by clear marking or labeling to ensure that no

confusion is possible regarding the status of the material.

8.3.4 Nonconforming product is accepted by concession only if customer

or regulatory requirements are met. The identity of the person(s)

authorizing the concession is maintained as quality records.

8.3.5 When nonconforming product is corrected, it is subject to

re-verification to demonstrate conformity with requirements.

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8.3.6 Rework plans are determined and prepared by authorized

personnel.

8.3.7 Any adverse effects of rework is documented and appropriately

dispositioned.

8.3.8 When nonconforming product is detected after delivery or use has

started, Veridiam takes action appropriate to the effects, or

potential effects of the nonconformity.

8.3.9 In addition to any contract or regulatory authority reporting

requirements, Veridiam provides for timely reporting of delivered

nonconforming product that may affect reliability or safety, and

complies with the requirements of 10CFR21 for nuclear products.

8.3.10 Notifications include a clear description of the nonconformity, which

includes, as necessary, parts affected, customer and/or Veridiam

part numbers, quantity, and dates(s) delivered.

8.3.11 Parties requiring notification of nonconforming product include, but

are not limited to suppliers, internal departments, customers,

distributors, and regulatory authorities.

8.3.12 Records of nonconformances and associated actions, including

concessions, are maintained in accordance with documented

procedures.

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8.4 Analysis of Data

8.4.1 Management determines data to be collected to demonstrate the

suitability and effectiveness of the quality management system, and

to evaluate where continual improvement of its effectiveness can

be made. This includes data generated as a result of monitoring

and measurement and from other relevant sources. This data is

made available for ongoing review and analysis and provides

information relating to:

a. customer feedback and satisfaction,

b. conformity to product requirements,

c. characteristics and trends of processes and products

including opportunities for preventive action, and

d. performance and reliability of suppliers

8.4.2 Records of data analysis are maintained in accordance with

documented procedures.

8.5 Improvement

8.5.1 Continual improvement: Veridiam continually improves the

effectiveness of the quality management system through the

implementation of the Quality Policy and Quality Objectives, audit

results, collection and analysis of performance data (internal and

external), corrective and preventive action, and actions resulting

from management review of the data.

8.5.1.1 Actions directed by management are augmented and

supported by an ongoing program of corrective and

preventive actions, initiated and executed at all levels

of the company.

8.5.1.2 The implementation of improvement activities and the

evaluation of the effectiveness of the results are

monitored.

8.5.1.3 Continual improvement opportunities can result form

lessons learned, problem resolutions and evaluations

of the effectiveness of the results.

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8.5.1.4 Veridiam establishes documented procedures for the

issue and implementation of advisory notices. These

procedures are capable of being implemented at any

time.

8.5.1.5 Customer complaints are documented in a database

and investigated in a timely manner to ensure the

validity of the complaint.

8.5.1.6 If investigation indicates that activities outside of the

organization contributed to the customer complaint,

relevant information is exchanged between all

organizations involved.

8.5.1.6 Customer complaints that are not followed by

corrective or preventive actions are justified by

authorized personnel.

8.5.1.7 When national or regional regulations require

notification of adverse events, corrective action

procedures are employed for notification to those

agencies.

8.6.1.8 Records of customer complaints are maintained in a

complaint database or in corrective/preventive

action files.

8.5.2 Corrective Action: Management and employees take systematic

action to eliminate the cause of deficiencies in product and

processes in order to prevent recurrence. Corrective actions are

appropriate to the effects of the deficiencies encountered.

Procedures regarding corrective actions are documented and

include:

a. reviewing nonconformities (including customer complaints),

b. determining the causes of nonconformities,

c. evaluating the need for action to ensure that nonconformities

do not recur,

d. determining and implementing action needed, including, if

appropriate, updating documentation,

e. recording the results of any investigation and action taken,

f. reviewing corrective action taken and its effectiveness,

g. flowing down corrective action requirements to a supplier,

when it is determined that the supplier is responsible for the

root cause,

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h. taking specific actions where timely and/or effective

corrective actions are not achieved, and

i. determining if additional nonconforming product exists based

on the causes of the nonconformities and taking further

action when required.

8.5.3 Preventive Action: Veridiam takes action to eliminate the cause of

potential nonconformities in order to prevent their occurrence.

Preventive actions are appropriate to the effects of the potential

problem. Documented procedures include the requirements for:

a. determining potential nonconformities and their causes,

b. evaluating the need for action to prevent occurrence of

nonconformities,

c. determining and implementing action needed,

d. records of resulting investigations and actions taken, and

e. reviewing the effectiveness of the preventive action taken.

8.5.3.1 The foundation of the preventive action program is the

combination of systems for document control; process

qualification and control; manufacturing control;

training, configuration control; infrastructure

management(including preventive maintenance);

monitoring and measurement; and corrective actions.

8.5.3.2 Sources of information that may be used to identify

additional opportunities for preventive action include:

a. nonconformance reports,

b. customer claims (complaints),

c. trend analysis,

d. failure mode effects, analysis studies, and

e. process capability data.

8.5.3.3 Preventive actions are appropriate to the effects of

the potential problems. When it has been determined

that preventive action is required, a plan for

accomplishment of specific actions is developed.

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permission of Veridiam. Inc. This document is to be returned or destroyed upon request of Veridiam Inc

8.5.3.4 The organization maintains a system for recording

preventive actions, and tracking the progress and

closeout of preventive action plans. These items are

reviewed periodically as part of the management

review process.

8.5.3.5 Programs that help to eliminate sources of problems

include process qualifications, process control,

configuration control, training and preventive

maintenance.

8.5.3.6 Records of preventive actions are in accordance with

documented procedures.

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permission ofVendiam, Inc. This document is to be returned or destroyed upon request of Vendiam Inc

Appendix A: Quality Management System Support and Implementation

R: Responsible for implementing all or part of the process

S: Responsible for supporting and participating in the process

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APPENDIX B

Structure of the Documentation Used in the Quality Management System

Documents which describe the Quality management system are listed below in order of

precedence. Documents used at the California-based Veridiam facilities are depicted in

Table 1.

Quality Manual (QM)

The Quality Manual (QM) is structured to include the requirements of the Foundational

Documents in the applicable section of the manual. The GM describes the policy requirements that Veridiam meets.

Implementing Procedures (CQP, IP and QSP)

Corporate Quality Procedures (CQP) are similar to second tier IPs. Where applicable,

CQP documents are used across Veridiam facilities.

Implementing Procedures (IP) are the second tier of documentation. These procedures

address how a requirement will be met at a particular Veridiam facility.

Quality Systems Procedures (QSP) are the second tier of documentation. These

procedures address how a requirement will be met at a particular Veridiam facility.

Amplifying Procedures (AP and SOP)

Amplifying Procedures {AP} and Standard Operating Procedures form the third tier of

documentation. APs and SOPs address details of how Quality System requirements are met.

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Process Documents, Records and Other Documents

Process Document and other documents are controlled per the requirements of this

manual. Such documents include, but are not limited to:

a. documents concerning procurement, identification, manufacturing, inspection,

preservation, maintenance, personnel training, and personnel qualifications and

certifications,

b. documents provided by customers to provide requirements and guidance for

supplier systems, processes, and products,

c. regulatory and industry standards and specifications, and

d. quality management system records to provide evidence of conformity to

requirements and the effective operation of the quality management system

Table 1

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permission of Vendiam. Inc This document is to be returned or destroyed upon request of Veridiam Inc.

APPENDIX C

Veridiam Organization Chart

Presidents

CEO

Chief

Financial

Officer

VP Human

Resources

Note: This organization chart is representative of

Veridiam's organization at the time of issue and is

subject to change. Changes in this Appendix are

approved without changing the revision level of this

document

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Veridiam Functional Organization and Responsibilities Appendix D

1.0 FUNCTIONAL ORGANIZATION

1.1 The management organization, referred to as "Management" in the Quality Manual, consists of the President & CEO and five, direct-report functional officers, vice presidents and directors:

a. Chief Financial Officer

b. Vice President, Sales

c. Director / Manager of Operations

d. Vice President, Engineering and Quality. The Director of Quality & Management Representative reports to the VP of Engineering & Quality as do the Director and Manager of Engineering

e. Vice President, Human Resources

2.0 RESPONSIBILITIES

2.1 The President & CEO is responsible for:

establishing and maintaining the Quality Management System (QMS) at Veridiam,

b. establishing and managing all business processes at Veridiam in accordance with corporate guidelines, and

c. approving the Quality Policy and Quality Objectives

The Vice President of Engineering and Quality is responsible for overall

administration of the Engineering and Quality functions. Within those functions the following are performed:

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2.2.1 The Engineering department is responsible for:

a. control and improvement of manufacturing processes

b. conferring with customers concerning technical issues

c. assisting customer with issues of manufacturability

d. new product development

e. new process development.

f. issuance of production planning, and

g. disposition of nonconforming material

h. performing risk assessments and analyses

i. root cause investigation and corrective action as appropriate

2.2.2 Quality Systems department is responsible for:

a. creation and monitoring of the quality management system internal

audits,

b. maintenance of the corrective and preventive action systems,

c. document control,

d. support of manufacturing in area of quality, compliance and

measurement systems,

e. calibration of measuring and test equipment,

f. supplier evaluation and approval,

g. external audits hosting and resultant actions,

h. records control,

i. inspection of product,

j. control of nonconforming product, and

k. generation and revision of the Quality Manual and quality

procedures that support the quality management system

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2.2.3 The Management Representative is responsible for (irrespective of other

duties):

a. ensuring that processes needed for the quality management

system are established, implemented and maintained,

b. reporting to top management on the performance of the quality

management system and any need for improvement,

c. ensuring the promotion of awareness of customer requirements

throughout the organization.

d. gathering appropriate information regarding the quality

management system,

e. dissemination of information regarding the quality management

system,

f. liaison with external parties on matters relating to the quality

management system, and

g. ensuring that customer and regulatory requirements are

communicated throughout the organization.

h. point of contact for third party representatives and customers, and

i. Management Reviews including:

• conducting management reviews,

• preparation of management review meeting materials including

presentations and minutes,

• supporting trend data and analysis

Note: In some cases, the Management Representative may be referred to

as the ''Responsible Engineering Manager."

2.3 The Operations Director is responsible for:

a. manufacturing and verification of conformity of production work

orders (fabrication and inspection),

b. shipment of products to customers,

c. control and improvement of production processes,

d. qualification, documentation and control of special processes,

e. maintaining identification and traceability of products,

f. safeguarding customer property,

g preservation of product, and

h. support of new product development and new business

development

i. root cause investigation and corrective action as appropriate

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2.4 The Vice President of Human Resources is responsible for:

a. recruitment and hiring,

b. benefits,

c. compensation,

d. employee relations,

overall management of employee performance reviews, f. training and development needs,

g. job descriptions,

h. temporary employee program, and

2.5 The Chief Financial Officer is responsible for:

a. accounting,

b. cost accounting for manufacturing activities, c. financial planning and forecasting,

d. providing processed financial data to internal and external users,

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