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 165.4 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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o o 3 En CD _Q C 3 (D 3
Figure 1: The Sequence and Interaction of the Quality Management System Processes Marketing Sales 72 Support Processes Core Processes Planning of Product Reaction 7.1 Purchasing 7 A ■Production 7.5.2 "Verification 7.4.3; 8.2 4 Handling, Storage, S Shipping 7 5 5.7.5.7
A-A
o c (/) o CD —i CO Q) K 03 O o'"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. Page: 20 of 57
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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),
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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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