Quality Manual

[Company Name][Company Group, Division, Location]

Document Title: Quality Manual

Document Number: [Document Number]Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPYSTAMP HERE

OTHERSTAMP HERE

Revision Level

Revision Date

DCO/ECONumber Description of Revision

Revision Author

DRAFT DD/MM/YY

YY-00000 Draft Author Name

1.00 DD/MM/YY

YY-00000 Initial Release Author Name

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Quality Manual[Company Group, Division, Location] [Document Number]

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Table of Contents

1.0 Purpose................................................................................................................................................. 3

2.0 Scope.................................................................................................................................................... 3

2.1 Introduction................................................................................................................................ 32.2 Company Contact Information....................................................................................................3

3.0 Definitions............................................................................................................................................ 3

4.0 References............................................................................................................................................ 3

5.0 Quality Policy and Mission Statement...................................................................................................4

5.1 Quality Policy............................................................................................................................. 45.2 Mission Statement...................................................................................................................... 4

6.0 Quality System Requirements............................................................................................................... 5

6.1 Management Responsibility........................................................................................................ 56.1.1 Standard Operating Procedures......................................................................................5

6.2 Quality System........................................................................................................................... 56.2.1 Quality System Documentation Organization................................................................66.2.2 Standard Operating Procedures......................................................................................6

6.3 Contract Review......................................................................................................................... 76.3.1 Standard Operating Procedures......................................................................................7

6.4 Design Control............................................................................................................................ 76.4.1 Program Management...................................................................................................76.4.2 Design Input.................................................................................................................. 76.4.3 Design Output............................................................................................................... 86.4.4 Design Verification and Validation...............................................................................86.4.5 Standard Operating Procedures......................................................................................8

6.5 Document and Data Control........................................................................................................ 86.5.1 Organizational Document Release and Control..............................................................96.5.2 Departmental Document Release and Control...............................................................96.5.3 Document and Data Changes.........................................................................................96.5.4 Standard Operating Procedures......................................................................................9

6.6 Purchasing................................................................................................................................ 106.6.1 Evaluation of Suppliers, Contractors, and Consultants.................................................106.6.2 Purchasing Data.......................................................................................................... 106.6.3 Verification of Purchased Products..............................................................................106.6.4 Standard Operating Procedures....................................................................................10

6.7 Control of Customer Supplied Product......................................................................................116.7.1 Standard Operating Procedures....................................................................................11

6.8 Product Identification and Traceability.....................................................................................116.8.1 Standard Operating Procedures....................................................................................11

6.9 Process Control......................................................................................................................... 126.9.1 Standard Operating Procedures....................................................................................12

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 23


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Table of Contents (cont.)

6.10 Inspection and Testing.............................................................................................................. 126.10.1 Incoming Inspection and Testing.................................................................................136.10.2 In-Process Inspection and Testing................................................................................136.10.3 Final Inspection and Testing........................................................................................136.10.4 Inspection and Test Records........................................................................................136.10.5 Standard Operating Procedures....................................................................................13

6.11 Control of Inspection, Measuring, and Test Equipment.............................................................146.11.1 Control Procedure.......................................................................................................146.11.2 Standard Operating Procedures....................................................................................14

6.12 Inspection and Test Status.........................................................................................................146.12.1 Standard Operating Procedures....................................................................................15

6.13 Control of Nonconforming Product...........................................................................................156.13.1 Review and Disposition of Nonconforming Product....................................................156.13.2 Standard Operating Procedures....................................................................................15

6.14 Corrective and Preventive Action..............................................................................................166.14.1 Corrective Action........................................................................................................ 166.14.2 Preventive Action........................................................................................................ 166.14.3 Standard Operating Procedures....................................................................................16

6.15 Handling, Storage, Packaging, Labeling, Preservation, and Delivery.........................................176.15.1 Handling..................................................................................................................... 176.15.2 Storage........................................................................................................................ 176.15.3 Labeling...................................................................................................................... 176.15.4 Packaging.................................................................................................................... 186.15.5 Preservation................................................................................................................ 186.15.6 Distribution................................................................................................................. 186.15.7 Standard Operating Procedures....................................................................................18

6.16 Control of Quality Records.......................................................................................................196.16.1 Device Master Records................................................................................................196.16.2 Device History Records...............................................................................................196.16.3 Design History File.....................................................................................................196.16.4 Standard Operating Procedures....................................................................................20

6.17 Internal Quality Audits.............................................................................................................. 206.17.1 Standard Operating Procedures....................................................................................21

6.18 Training.................................................................................................................................... 216.18.1 Standard Operating Procedures....................................................................................21

6.19 Servicing.................................................................................................................................. 216.19.1 Customer Service........................................................................................................ 216.19.2 Field Service............................................................................................................... 226.19.3 Standard Operating Procedures....................................................................................22

6.20 Statistical Techniques............................................................................................................... 226.20.1 Standard Operating Procedures....................................................................................22

7.0 Organization Chart.............................................................................................................................. 23



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1.0 Purpose

This document defines [Company Name] Quality System Policies and Procedures for governing the design, development, manufacture, distribution, installation, and servicing of all [Company Name] products.

2.0 Scope

[Company Name] acknowledges its responsibility as a manufacturer of [industry/product name] to adhere to all applicable regulatory and industry standards. This manual specifies the policies and procedures that comprise the [Company Name] Quality System. The system is compliant with ISO 9001: 2000 standard for Quality Management Systems and The Food and Drug Administrations Quality System Requirements specified in 21 CFR Part 820.

2.1 Introduction

[Company Name] designs, develops, manufactures, and distributes [products].

[Insert the company history here]

2.2 Company Contact Information

[Company Name] is located at:

[Insert company address here]Phone:Fax:E-mail:Web site:

Other operating units include:[Insert company address here]Phone:Fax:E-mail:Web site:

3.0 Definitions

Unless otherwise specified, definitions provided in Title 21 of the Code of Federal Regulations, Parts 803 and 820 will be used as the official definition.

Definitions found in ISO 9001, and ISO 8402 will be used for terms defined in these ISO documents but not referenced in the Code of Federal Regulations.

4.0 References

This manual is organized and written to comply with the provisions of the following documents and standards: International Standards Organization Standards ISO 9001:2000; ISO 13485; EN 46001; The Medical Device Directive, MDD 93/42/EEC; US Department of Health and Human Services, Food and Drug Administration Quality System

Regulation, Title 21 of the Code of Federal Registrations, Part 820.

[Company Name] will comply with the most recent edition of the aforementioned documents and standards as well as new standards that Quality Assurance deems appropriate. [Company Name] will



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make necessary revisions to its Quality System to insure continued compliance will applicable standards.

All references to specific policies, procedures, or work instructions in this manual are the latest revision of that document unless otherwise noted.

All references to personnel in this manual are that person or his/her designated representative unless otherwise stated.

5.0 Quality Policy and Mission Statement

5.1 Quality Policy

The Quality Policy is formulated by the President/CEO of [Company Name] and approved by [Company Name]’s board of directors. It is [Company Name]’s policy to ensure that all employees are aware of the Quality Policy. This awareness is achieved by presentation and discussion of the policy during employee training sessions and by positing the Quality Policy in conspicuous locations throughout the company facilities.

[Company Name is committed to becoming the leader in the [industry] and to deliver high quality, innovative products that meet or exceed our customer’s requirements. [Company Name] will deliver defect-free products and services on schedule and on budget while maintaining compliance with applicable regulatory and industry standards.

5.2 Mission Statement

[Insert [Company Name]’s Mission Statement here]



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6.0 Quality System Requirements

6.1 Management Responsibility

Management identified on the Functional Organization Chart (See Section 7.0 of this procedure) is responsible for the following: Implementation and maintenance of the Quality System in their respective areas; Training of their personnel in the applicable Quality System areas including the use of

policies, procedures, and work instructions; Product and service quality in their area; Audit support and corrective action development and implementation; and Promotion of continuous improvement.Management may delegate authority to others, however, the original assignee retains the responsibility for the proper execution of the delegated activity.

The Quality Systems Manager, under the direction of the Chief Executive Officer of [Company Name], is responsible for the establishing and maintaining of the Quality Policy and the Quality System. The Quality Systems Manager will insure that all [Company Name] personnel understand the Quality Policy and the company's commitment to quality. The Quality System Manager also is responsible for: The preparation and presentation of the annual Quality System status reports to Senior

Management for their review and possible action in accordance with procedure; The release and recall of product and services to or from distribution and/or customers; Documentation control; Independence of personnel responsible for the inspection, testing, and verification of

products and services including their adequacy and fitness to perform those functions; Development and use of relevant, statistical-based benchmarks to continuously measure the

Quality System performance and make all personnel aware of their meaning and significance; and

Regulatory compliance.

All [Company Name] employees are responsible for the quality of products and services provided.

6.1.1 Standard Operating Procedures

Functional Organization Chart Preparation and MaintenanceQuality System Report to Senior Management

6.2 Quality System

[Company Name] will establish a Quality System in accordance with the standards referenced in this Manual. The Quality System consists of the Policies outlined in this Manual, Standard Operating Procedures [SOPs], and Work Instructions. The Quality Systems Manager is responsible for maintaining the Quality Policy, this Manual and the Quality System Procedures. Individual departments and sections are responsible for maintenance of the Standard Operating Procedures and Work Instructions relative to their assigned activities. The Quality Department is responsible for organizing, controlling, and maintaining the Quality System under the direction of the Quality Systems Manager. The Quality Systems Department also is responsible for the following activities, which are outlined more fully in other sections of this manual and the Quality System policies, procedures, and work instructions: Quality plan preparation; Statistical data and "benchmarking" to measure Quality System effectiveness. Assistance

with process development needed to achieve quality; Government and regulatory agency records development and maintenance. Quality records

handling and maintenance;



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Complaint and corrective action handling, processing, and closure. Medical device records maintenance;

Quality Assurance, inspection, and testing technique updates including new instrumentation and methods development;

Quality Records identification and maintenance. Measurement identification and compatibility; Document control; Participation in product and service design and program status reviews.; Quality System auditing; Ascertaining that all outgoing products meet specified requirements; and Identifying and preventing quality deficiencies in product, process, and the Quality System.

6.2.1 Quality System Documentation Organization

[Company Name] will organize its Quality System documentation as follows:

[Insert a description of the Quality System documentation here. Include the following Quality System (organizational) structure according to ISO 9001:

Tier 1 Quality Manual and PoliciesTier 2 Standard Operating Procedures [SOPs]Tier 3 Quality Records and Work Instructions [includes data, training records,

files, etc.]

[Insert a description of the Product Documentation here. Include the following Tier 1 Product Design Requirement (Program Management Plans, Product

Requirement Documents, Etc.)Tier 2 Product Definition &Documentation Engineering Drawings, Part

Drawings Schematics, Etc.Tier 3 Process Definition & Documentation specific Mfg. Instructions, Inspection

Instructions Travelers, Quality Records Design History, Device History, Etc.]


Control of Confidential/Proprietary Information Document Retention, Storage and Disposition Customer Complaint Processing Data Back-up Procedures Corrective and Preventive Action Quality Information System Quality Records MDR/MDVS Reports Quality Investigation Returned Product Authorization, Evaluation, and Disposition Traceability Organizational Document Release and Change Control Production Document Release and Change Control Production Document Standards Released Document Control Production Numbering System Interim Changes Product Labeling Control of Documents of External Origin

6.3 Contract Review

[Company Name] will establish and maintain documented procedures for contract review.



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[Insert contract review policy/procedural requirements and responsibilities here. Discuss the following:

Who assigns personnel to review contracts;A statement specifying that reviewers are responsible to review contracts to ensure that customer requirements can be met and that orders are accurate;Who is responsible for communicating customer requirements to appropriate departments prior to acceptance;Specify who will maintain records of all contract reviews;Specify who is responsible for the input and maintenance of accepted orders into the MRP system;A statement specifying the types of contracts secured by the company including: Service contracts Customer contracts specifying [Company Name] as sole contractor Customer contracts specifying [Company Name] using subcontractors Customer contracts with [Company Name] as a subcontractor.]


Contract Review

6.4 Design Control

[Company Name]’s Program Management Team will establish and maintain documented procedures to ensure that its products meet specified requirements. Procedures to control, verify and validate product design through the life of the product.

6.4.1 Program Management

The Program Management Cycle consists of five [5] phases. Each of the phases has specific deliverables that cover both the business and technical development of a product and/or service. These five [5] phases are:

Concept; Feasibility; Planning; Development; and Production and Support.

[Insert control of program management policy/procedural requirements and responsibilities here. Discuss the following:

How program management documentation will be controlled; Who is responsible for conducting design reviews, when they are to be conducted, and how the results will be recorded; Who is responsible for product and/or design control; Specify who has the authority to form product development teams; Specify the product development team responsibilities.]

6.4.2 Design Input

Design input will be prepared during the Concept and Feasibility phases. The preparation of a marketing/design requirements document is essential to establish the design criteria for a product.

6.4.3 Design Output

The documentation resulting from the Planning, Development, and Production phases will be the design output. It will include prototype(s), documentation including test specifications, drawings, parts lists, etc., and engineering reports. Also included are cost analysis, MRP loading, and manufacturing process flow for products.



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6.4.4 Design Verification and Validation

Product verification and validation will be conducted during the Development and. Process validation will be conducted and reported also, if applicable. With the successful completion of these phases, the product documentation will be brought to Production Release in accordance with established procedures.A Pilot Production phase may be conducted as a final trial run of the product design and complete manufacturing process design. Any changes to the final product design and manufacturing process flow are made prior to release for Full Production.


Human Clinical Studies Development of Design Input Requirements Preparation of a Design Requirements Document The Product Development Cycle Preparation of a Program Plan Preparation of a Program Feasibility Study Development of Design Output Design Review Design Verification Design Validation Design Transfer Design History File Preparation of a Technical Report Experimentation Process Preparation of a Technical File

6.5 Document and Data Control

[Company Name] will establish and approve all documents and data prior to their issuance and use. All documentation will be controlled. [Company Name]'s documentation will include but is not limited to: Centrally controlled databases; Company business reports; Forms; The Quality System Manual; Policies; Standard Operating Procedures; Work Instructions; Published Standards and other documents of external origin; Design documentation including the Design History File Records Device History Records Device Master Records

[Insert document and data control policy/procedural requirements and responsibilities here. Discuss the following: Who is responsible for administering document control activities; How will individual departments control department specific documents, and records; Who is responsible for approving organization documents.]

6.5.1 Organizational Document Release and Control

All organizational documentation will be released by signature or other recognized positive document and data control through Technical Support Services Department. An electronic file listing all controlled documents and data will be maintained by Technical Support Services Department. This file will contain but is not limited to the following information:



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Unique name and control number Current revision Authorizing job function Issue date

Master organizational document and data lists identifying level of approval, distribution, and revision status will be maintained. Where applicable organizational documents and data will be controlled and available through an electronic system. Only current versions will be available for use. All invalid and obsolete versions will be purged from the active system and archived. Any printed copies of electronic files are considered to be uncontrolled and "for reference only" unless otherwise marked. Uncontrolled documents and data include, but are not limited to the following:

Informational literature Trade publications

Controlled hard copies will be clearly marked as such. Technical Support Services Department will establish sufficient procedures including tracking lists to assure the positive location and retrieval of all controlled hard copies that may be issued in accordance with the Production Document Change Control procedure.

6.5.2 Departmental Document Release and Control

Departments issuing work instructions, procedures, and other data will maintain a master document list indicating approval level, distribution, and revision status. They also will maintain procedures including tracking lists to ensure positive location and retrieval of all controlled copies. All invalid and obsolete issues will be removed from use. Any printed copies are considered uncontrolled unless otherwise designated and are for reference only.

6.5.3 Document and Data Changes

[Insert document and data changes policy/procedural requirements and responsibilities here. Discuss the following:

Who is responsible for reviewing and approving revisions or modifications to documents and data; How will document changes be communicated to individuals; How will document and data changes historical data be archived.]


Organizational Document Release and Change Control Production Document Release and Change Control Production Document Standards Released Document Control Production Numbering System Interim Changes Product Labeling Control of Documents of External Origin Quality Records Production Document Emergency Revision Master Training Plan

6.6 Purchasing

[Company Name] will establish and maintain procedures to control the purchase of all materials, supplies, and services used for the manufacture and supply of products and services.



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[Insert purchasing policy/procedural requirements and responsibilities here. Discuss the following: Who is responsible for the purchase of materials, supplies, and services; Who is responsible for qualifying suppliers/vendors; A statement regarding the use of materials purchased from approved suppliers only.]

6.6.1 Evaluation of Suppliers, Contractors, and Consultants

Suppliers will be selected on the basis of their ability to meet specified requirements, including quality requirements. The type of product, supplier survey information, and past performance relating to quality, delivery, cost, and responsiveness are considered in the supplier selection process, which is carried out according to the Supplier Quality Requirements and Survey procedure.The Quality Department will maintain a list of approved suppliers for purchased products in the Supplier Performance Database in accordance with the Supplier Performance Rating procedure. Acceptable performance ratings are required to remain on approved supplier list. The Material Support Department and Quality Assurance will produce supplier performance ratings.

6.6.2 Purchasing Data

[Insert purchasing document data requirements here. Include the following types of data:

Part number, description, quantity, grade, or other precise identification; Drawings, specifications, process requirements, inspection instructions, and other relevant technical data, as applicable; Title, number, and revision of quality system documents to be applied to the product or service; and Any special documented instructions deemed necessary.

Also discuss which department will generate, approve and review purchase requests and documentation. Specify how specific technical requirements will be communicated to subcontractors.]

6.6.3 Verification of Purchased Products

[Company Name] will inspect and/or test the materials, supplies, or contracted items as prescribed in the procedure entitled Incoming Inspection. When appropriate, source inspection is performed depending on the significance of purchased products and supplier's past quality history. Incoming inspection records are maintained in accordance with quality plans and/or documented procedures.


Material Control Processes Supplier Quality Requirements & Survey Supplier Performance Rating Material Review Board Incoming Inspection First Article Inspection Calibration Service Qualification

6.7 Control of Customer Supplied Product

[Company Name] will establish and maintain procedures for the receipt, storage, and use of customer-supplied products for the incorporation into products, systems, or applications. These



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materials and supplies will be handled in the same manner as those that are purchased in accordance with Section 6.6 of this manual.

[Insert control of customer supplied product policy/procedural requirements and responsibilities here. Discuss the following:

The disposition of lost or damaged product; Who is responsible for the receipt, identification, storage and issue of customer supplied

products; Who is responsible for ensuring that customer supplied materials meet established

specifications; Who is responsible for segregating and controlling purchased materials and supplies.]


Material Control Processes Material Review Board Incoming Inspection

6.8 Product Identification and Traceability

[Company Name] will establish and maintain procedures for identifying product and acceptance status during all stages of receipt, production, distribution and installation. [Company Name] will also establish and maintain documented procedures or unique identification of individual product or batches. Identification and traceability procedures will specify that identification data will be recorded.

[Insert product identification and traceability policy/procedural requirements and responsibilities here. Explain the following:

Who is responsible for identification and traceability activities; Who is responsible for establishing procedures pertaining to devices intended for surgical

implant into the body Who is responsible for maintaining identification and traceability records.]


Material Control Processes Production Number System Product Release Material Inspection Status Traceability

6.9 Process Control

[Company Name] will establish and maintain documented procedures to identify, develop, conduct; control, modify, and monitor production methods, processes and specifications that directly affect quality to ensure that each device conforms to its specifications. [Company Name] will also establish and maintain documented procedures defining the manner of production, installation, and servicing.

[Insert process control policy/procedural requirements and responsibilities here. Discuss the following:



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A statement regarding processes used during production, installation, and servicing of products are carried out under controlled conditions;

Specify the controlled conditions for various processes including:

Work instructions, work environment and facilities, compliance of standards, etc.; Monitoring and control of process and product characteristics; A statement regarding criteria for workmanship standards; A statement regarding the establishment of health regulations and personal hygiene of

all personnel involved in the manufacturing process and personnel working under special environmental conditions;

A statement regarding the cleanliness and orderliness of the work environment; A statement regarding the maintenance of all equipment used in the manufacturing

process including the establishment of equipment maintenance schedules, audits, adjustment parameters.

Who is responsible for maintaining process control records.]


Janitorial Procedures Controlled Environments: ESD Production Equipment Preventive Maintenance Creation, Use, and Maintenance of Travelers Controlled Environments: Airborne Particulates Process Validation Workmanship Standards Manufacturing Planning and Tracking Sterilization Qualification and Control Internal Quality Audits Corrective and Preventive Action Quality Investigation Mold, Fixture, Jig Certification

6.10 Inspection and Testing

[Company Name] will establish and maintain documented procedures for inspection and testing activities in order to verify that the specified product requirements are met. Quality plans; work procedures and instructions will specify the inspection, testing, and records requirements for specific products.

[Insert inspection and testing policy/procedural requirements and responsibilities here. Explain the following:

Employees’ responsibilities and methods used for inspecting their own work; Who is responsible for various inspection activities including: audit, final test, and product

release; and Who is responsible for maintaining inspection records.]

6.10.1 Incoming Inspection and Testing

[Insert incoming inspection and testing policy/procedural requirements and responsibilities here. Explain the following:

Statement regarding inspection prior to use; Statement regarding verification of conformance to requirements and the inspection status;



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Statement regarding subcontractor evidence of conformance included with shipment; Statement regarding incoming product released for production prior to verification.]

6.10.2 In-Process Inspection and Testing

[Insert in-process inspection and testing policy/procedural requirements and responsibilities here. Explain the following:

Statement regarding inspection requirements; and Statement regarding how inspection records are processed and maintained.]

6.10.3 Final Inspection and Testing

[Insert final inspection and testing policy/procedural requirements and responsibilities here. Explain the following:

Statement regarding who will carry out final inspection and how the results will be documented; Statement regarding how final inspection impacts product shipment; Statement regarding disposition of finished products pending inspection activities and release authorization prior to distribution.]

6.10.4 Inspection and Test Records

[Insert inspection and testing records policy/procedural requirements and responsibilities here. Explain the following:

Statement regarding who will maintain inspection records, how records will be maintained, and that the records provide evidence that the product was inspected; Statement regarding procedures applicable where the product fails inspection/testing; Statement regarding identification of inspection authority responsible for the release of the product; Specify key items to be included in acceptance record documentation including Assignment and application of serial number, Acceptance activities performed, Dates, the acceptance activities were performed, Results, Signature or initials of the individual(s) conducting the acceptance activities and where appropriate, the specific equipment used.]


Material Review Board Incoming Inspection In Process Inspection Final Inspection Product Release First Article Inspection Material Inspection Status Acceptance Sampling Plans Stop/Resume Work/Shipment Quality Information System Quality Records Quality Investigation Traceability



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6.11 Control of Inspection, Measuring, and Test Equipment

[Company Name] will establish and maintain procedures to specify the control, calibration, and maintenance of inspection, measuring and test equipment, whether owned by [Company Name] or rented. All equipment used in [Company Name] facilities, whether company owned, rented, or personal will be included in the calibration system regardless of its application.

[Insert company policy here. Discuss employee responsibilities regarding the following: labeling and use of equipment; reporting of damaged/potentially damaged equipment; function responsible for calibration and maintenance records; calibration of personal tools.]

6.11.1 Control Procedure

[Insert control policy and procedural responsibilities here. Discuss the following:

How equipment and standards will be handled and stored, include how the activities will be documented; Inspection of test hardware and software and the availability of test results for verification purposes; Use of calibration standards and traceability to test equipment; Documentation and maintenance of calibration records including:

An individual record of calibration for each item A description of the item, Calibration date, Individual performing the calibration, Calibration procedure, Calibration results and any action taken.]


Controlled Environments: Airborne Particulates Test and Measurement Equipment Calibration Service Qualification Quality Records

6.12 Inspection and Test Status

[Company Name] will establish and maintain an inspection and test status indication system for all products used in the production process to ensure that the inspection and test status of materials is identifiable at all times.

[Insert inspection and test status policy/procedural responsibilities here. Discuss the following:

Employee responsibilities regarding use of acceptable material, and reporting of improperly identified materials;

Employees responsible for indicating inspection status; How the inspection and test status of product will be identified. The identification methods

used should ensure that only conforming product is processed for distribution. Examples of identification methods include: markings, authorized stamps, tags, labels, work orders, inspection records, test software, physical location, and/or other suitable means, that indicate conformance or nonconformance of product with regard to inspection and tests performed.

Who is responsible for the identification of nonconforming materials and how those materials will be identified;

How will finished product be segregated until released; The maintenance of records including the identification of the inspection authority

responsible for releasing product.]



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Material Control Processes Sterilization Qualification and Control Material Inspection Status Quality Records Traceability

6.13 Control of Nonconforming Product

[Company Name] will establish and maintain documented procedures to ensure that nonconforming materials (e.g., components, manufacturing materials, subassemblies, finished products, returned products, etc.) that do not conform to the specified requirements are prevented from unintended use or installation. Nonconforming materials will be subject to identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product, and for notification to the functions concerned.

[Insert control of nonconforming product policy/procedural responsibilities here. Discuss the following:

Who is responsible for the segregation of nonconforming product and material and the acquisition of return authorization for materials that are being returned to a supplier;

Who is responsible to acquire disposition for nonconforming product and material, the procedure used to determine disposition, and the final authority for disposition of product and material.]

6.13.1 Review and Disposition of Nonconforming Product

The disposition of nonconforming product will be reviewed and may be one or more of the following:

Reworked or reprocessed to meet specified requirements; Accepted as is; Returned to vendor/subcontractor; Sorted; and Scrapped.

The documentation of the disposition will include the description of the nonconformity that has been accepted or the reprocessing that was authorized, and the acceptance criteria that will be used. All reprocessed product will be reinspected in accordance with the quality plan, documented procedures, and/or acceptance criteria in accordance with the Material Review Board procedure.


Material Control Processes Material Review Board Stop/Resume Work/Shipment Quality Records

6.14 Corrective and Preventive Action

[Company Name] will establish and maintain documented procedures for implementing corrective and preventive action to ensure that any actions taken to eliminate the causes of actual or potential nonconformities are appropriate to the magnitude of the problem and commensurate with the risks encountered. [Company Name] will implement and record any changes to the



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documented procedures resulting from corrective and preventive action in accordance with the operating procedures listed in section 4.14.4

[Insert corrective and preventive action policy/procedural responsibilities here. Discuss the following:

Which function is responsible for administering corrective and preventive actions; Who is responsible for initiating corrective and preventive actions; Who is responsible for investigating and responding to corrective action requests.]

6.14.1 Corrective Action

The procedures for corrective action will include but are not limited to:

Customer complaint handling and reporting of product nonconformities; Nonconformity root-cause investigation and reporting regarding product, process, and quality system; and Determination and implementation of the corrective action needed to eliminate the cause of nonconformity and application of controls to ensure that corrective action is taken and that it is effective.

6.14.2 Preventive Action

The procedures for preventive action will include but is not limited to:

The use of appropriate sources of information such as processes, work operations, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems. Determination of the steps needed to deal with any problems requiring preventive action. Initiation of preventive action and application of controls to ensure that it is effective. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems. Ensuring that relevant information on actions taken is submitted for management review.


Customer Compliant Processing Material Review Board Customer and Regulatory Audits Internal Quality Audits Corrective and Preventive Action Stop/Resume/Work/Shipment Correction or Removal of Marketed Products Quality Information System Quality Records MDR/MDVS Reports Quality Investigation Returned Product Authorization, Evaluation, and Disposition Organizational Document Release and Change Control Production Document Release and Change Control



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6.15 Handling, Storage, Packaging, Labeling, Preservation, and Delivery

[Company Name] will establish and maintain documented procedures for handling, storage, packaging, labeling, preservation, and delivery to ensure that all materials and products will be handled, stored, packaged, labeled, preserved, and delivered in a manner that ensures integrity, controls their distribution, and maintains quality through delivery.

6.15.1 Handling

All production and process materials (e.g., components, manufacturing materials, subassemblies, sterile materials, customer supplied materials, and finished products) will be handled in such a manner as to prevent confusion, damage, adulteration, deteriorization, or other adverse effects.

[Insert handling policy/procedural responsibilities here. Discus the following:

Define who is responsible for handling products and the manner/precautions required during the handling process.]

6.15.2 Storage

All materials and products will be stored in designated areas that ensure their integrity and also afford adequate controls for issuance and receipt. [Company Name] will utilize sound inventory control methods, including verification of limited life materials and the first-in-first-out (FIFO) issuance of materials and products.

[Insert storage policy/procedural responsibilities here. Discus the following:

Define who is responsible for storing products and the manner/precautions required during the storage process; Define who is responsible for controlling the issue of stored materials; Define who has access to storage locations.]

6.15.3 Labeling

All finished products will be labeled in such a manner as to prevent confusion, and ensure positive identification by ensuring labels are designed, printed, and are applied to remain legible and affixed during customary conditions of processing, storage, handling, distribution, and use.

A Product Identification Label will consist of, but is not limited to:

Product name and current trademark status; Product specific identification numbers such as catalog numbers; Identifying description; Quantity, lot, or serial number, if required; and Expiration date, if required.

[Insert labeling policy/procedural responsibilities here. Discus the following:

A statement regarding the labeling for critical devices containing control numbers; Define who is responsible for creating and approving subassembly/product labels; Define who is responsible for controlling the issuance of labels; Define who is responsible for controlling the labeling operations.]



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6.15.4 Packaging

[Company Name] will ensure that packaging and shipping containers are designed and constructed to ensure that production and process materials, sterile materials, customer supplied materials, and finished products will be protected against damage, deterioration or contamination by use of packaging and storage materials which comply applicable regulations.

[Insert packaging policy/procedural responsibilities here. Discus the following:

A statement regarding the packaging for critical devices containing control numbers; Define who is responsible for creating and approving subassembly/product packaging and shipping containers; Define who is responsible for controlling the issuance of packaging materials; Define who is responsible for controlling the packaging operations.]

6.15.5 Preservation

[Company Name] will apply appropriate methods for preservation and segregation of product to prevent damage, loss or contamination, excessive storage time, or adverse environmental conditions.

[Insert Preservation policy/procedural responsibilities here. Discus the following:

Define who is responsible for preserving and segregating product; Define who is responsible for controlling and maintaining the preservation environment.]

6.15.6 Distribution

[Company Name] will ensure that only those products approved for release are distributed. All products will be packaged by [Company Name] in a manner that ensures the integrity of the product through delivery to the customer. Product shipments will be identified by model/control numbers, shipping date, customer name and address, quantity shipped, and shipping personnel. Distribution records will be maintained in the Device History Record to protect the quality and traceability of items shipped.

[Insert distribution policy/procedural responsibilities here. Discus the following:

Define who is responsible for controlling the product distribution process; Define who is responsible for maintaining distribution records; Specify how product shipments will be identified. Include the following: Customer name and address, quantity ordered, quantity shipped, shipping date, model numbers, control numbers, etc.]


Controlled Environments: ESD Controlled Environments: Airborne Particulates Material Control Process Organizational Document Release and Change Control



Rev x.xx DD/MM/YY

6.16 Control of Quality Records

[Company Name] will establish and maintain documented procedures for the control of quality records including: identification, collection, indexing, access, filing, storage, maintenance, disposition, and disclosure.

[Insert control of quality records policy/procedural responsibilities here. Discus the following:

A statement regarding the legibility of quality records; Define who is responsible for defining, controlling and maintaining quality records.]

6.16.1 Device Master Records

[Company Name] will establish and maintain device master records (DMRs) for each type of device for which it has design authority. Each DMR will include, or refer to the location of the following information:

Device specifications including appropriate drawings, schematics, component and software diagrams, component specifications, functional requirements, etc.; Production process specifications including appropriate production methods, processes and equipment; Packaging and labeling specifications, including methods and processes used; and Installation and maintenance procedures and methods.

6.16.2 Device History Records

[Company Name] will establish and maintain device history records (DHRs) for each device manufactured for which it has design authority. Each DHR will show the processes, inspection/test and rework that occurred from the beginning of manufacture through distribution.

Device History Records will include but are not limited to the following:

Incoming inspection records In-process inspection records Final inspection records Nonconforming material records MRB records Rework orders Training records Certification/qualification records Calibration records Work Orders, Travelers, Assembly Instructions Purchase orders Labeling records and documents Packaging and distribution records

6.16.3 Design History File

[Company Name] will establish and maintain a design history file (DHF) for each device manufactured for which it has design authority. Each DHF will contain but is not limited to the following:

Laboratory Notebooks Conceptual Drawings and Illustrations Engineering Drawings Schematics



Rev x.xx DD/MM/YY

Component Specifications Design Requirements Program Plans Design Review Minutes Engineering Change Orders Design Verification and Validation Test Plans Design Verification and Validation Test Results


Document Retention, Storage and Disposition Production Employee Training Material Control Processes Quality Information System Quality Records Released Document Control Incoming Inspection In-process Inspection Final Inspection Controlled Environments: Airborne Particles Controlled Environments: ESD Creation, Use, and Maintenance of Travelers Approval and Maintenance of Process Equipment Preventive Maintenance Development of a Program Plan Design Input Design Output Design Review Design Transfer Design Change Design Verification and Validation

6.17 Internal Quality Audits

[Company Name] will establish and maintain documented procedures for conducting internal audits. [Company Name] will conduct internal audits to examine the effectiveness of the Quality System and the quality of the manufactured products and services. The results from the audits will be used to develop new and revised quality plans and to modify the existing Quality System as appropriate.

[Insert Internal quality audit policy/procedural responsibilities here. Discus the following:

A statement regarding how audit reports and documents are maintained and how the dissemination of audit reports is controlled (e.g., confidential and proprietary);

Define who is responsible for developing and documenting the annual audit schedule and plan;

A statement regarding audit schedule priorities; Define who is responsible for conducting internal auditor training and ensuring the

qualifications of internal auditors; Define who is responsible for assigning auditors to conduct audits, and how the audit

results will be processed; Define who is responsible for developing corrective action plans and how they are

processed; Define who is responsible for maintaining and improving the Quality System; Define who is responsible for reporting the status and effectiveness of the internal audit

plan to senior management.]



Rev x.xx DD/MM/YY


Control of Confidential/Proprietary Information Internal Quality Audits Auditor Training Corrective and Preventative Action

6.18 Training

[Company Name] will establish and maintain documented procedures for training and development to ensure that all personnel are trained to adequately perform their assigned responsibilities. Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training, and/or experience, as required.

[Insert training policy/procedural responsibilities here. Discus the following:

Specific Quality System training requirements including FDA Quality System Regulation, ISO 9001,Continuous Quality Improvement, Total Quality Management, etc.;

A statement specifying that all personnel will receive Quality System training pertaining to their specific job requirements and the impact in terms of device defects which may result from improper performance of their specific job;

Define who will maintain written job descriptions for employment positions; Define who will conduct job-specific training; Define how training records will be documented and maintained and who is responsible for

these tasks.]


Master Training Plan Production Employee Training Auditor Training

6.19 Servicing

6.19.1 Customer Service

[Company Name] will establish and maintain documented procedures for customer complaint handling to ensure that all customer complaints are effectively processed and appropriate actions initiated. The Customer Service Department will receive and track customer complaints and assist the Quality Department in monitoring the quality of its products and services.

[Insert specific customer service activities here.]

[Insert customer service policy/procedural responsibilities here. Discus the following:

Who is responsible for establishing procedures, for receiving, documenting, tracking, reporting and follow-up of complaints, etc., and implementing customer support; Define other customer service responsibilities including who is authorized to receive and document customer complaints, receive orders, change orders, perform contract review, etc.]

6.19.2 Field Service

[Company Name] will establish and maintain documented procedures for performing and documenting service of marketed products to ensure the continued operation, reliability, and safety of all marketed products.



Rev x.xx DD/MM/YY

[Insert specific field service activities here.]

[Insert field service policy/procedural responsibilities here. Discus the following:

Who is responsible for establishing procedures, for performing, documenting, tracking, reporting and follow-up of maintenance, service, and repairs, etc., and writing service manuals and Field Technical Bulletins; Define other Field service responsibilities including who is authorized to repair, service, and document marketed product, etc.]


Customer Servicing Customer Compliant Processing Contract Review Customer Order Processing Product Service Service Manuals Field Technical Bulletins Product Service Request Form Processing

6.20 Statistical Techniques

[Company Name] will establish and maintain documented procedures for the implementation and control of statistical applications including but not limited to sampling plans, control charts, histograms, Pareto diagrams, etc. [Company Name] will also identify statistical techniques appropriate for verifying the acceptability of its process capabilities and product characteristics.


Acceptance Sampling Plans



Rev x.xx DD/MM/YY

7.0 Organization Chart


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