Quality Manual

[Company Name]
[Company Group, Division, Location]
Document Title: Quality Manual

Document Number: [Document Number]
Document Filename: [Document Filename]
CONTROLLED COPY/ MASTER COPY

STAMP HERE
OTHER
STAMP HERE
Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y
COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Quality Manual
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY
Table of Contents
1.0 Purpose..........................................................................................................................................................3
2.0 Scope.............................................................................................................................................................3
2.1 Introduction........................................................................................................................................3
2.2 Company Contact Information..........................................................................................................3
3.0 Definitions....................................................................................................................................................3
4.0 References.....................................................................................................................................................3
5.0 Quality Policy and Mission Statement.........................................................................................................4

5.1 Quality Policy....................................................................................................................................4
5.2 Mission Statement..............................................................................................................................4
6.0 Quality System Requirements......................................................................................................................5

6.1 Management Responsibility..............................................................................................................5
6.1.1 Standard Operating Procedures...........................................................................................5
6.2 Quality System...................................................................................................................................5
6.2.1 Quality System Documentation Organization....................................................................6
6.3 Contract Review................................................................................................................................7
6.4 Design Control...................................................................................................................................7
6.4.1 Program Management.........................................................................................................7
6.4.2 Design Input........................................................................................................................7
6.4.3 Design Output......................................................................................................................8
6.4.4 Design Verification and Validation....................................................................................8
6.5 Document and Data Control..............................................................................................................8
6.5.1 Organizational Document Release and Control.................................................................9
6.5.2 Departmental Document Release and Control...................................................................9
6.5.3 Document and Data Changes..............................................................................................9
6.6 Purchasing........................................................................................................................................10
6.6.1 Evaluation of Suppliers, Contractors, and Consultants....................................................10
6.6.2 Purchasing Data.................................................................................................................10
6.6.3 Verification of Purchased Products...................................................................................10
6.6.4 Standard Operating Procedures.........................................................................................10
6.7 Control of Customer Supplied Product...........................................................................................11
6.8 Product Identification and Traceability...........................................................................................11
6.9 Process Control................................................................................................................................12
[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 23

Rev x.xx DD/MM/YY
Table of Contents (cont.)
6.10 Inspection and Testing.....................................................................................................................12

6.10.1 Incoming Inspection and Testing......................................................................................13
6.10.2 In-Process Inspection and Testing....................................................................................13
6.10.3 Final Inspection and Testing.............................................................................................13
6.10.4 Inspection and Test Records.............................................................................................13
6.11 Control of Inspection, Measuring, and Test Equipment.................................................................14
6.11.1 Control Procedure..............................................................................................................14
6.12 Inspection and Test Status...............................................................................................................14
6.13 Control of Nonconforming Product.................................................................................................15
6.13.1 Review and Disposition of Nonconforming Product........................................................15
6.14 Corrective and Preventive Action...................................................................................................16
6.14.1 Corrective Action..............................................................................................................16
6.14.2 Preventive Action..............................................................................................................16
6.15 Handling, Storage, Packaging, Labeling, Preservation, and Delivery...........................................17
6.15.1 Handling............................................................................................................................17
6.15.2 Storage...............................................................................................................................17
6.15.3 Labeling.............................................................................................................................17
6.15.4 Packaging...........................................................................................................................18
6.15.5 Preservation.......................................................................................................................18
6.15.6 Distribution........................................................................................................................18
6.16 Control of Quality Records..............................................................................................................19
6.16.1 Device Master Records.....................................................................................................19
6.16.2 Device History Records....................................................................................................19
6.16.3 Design History File............................................................................................................19
6.17 Internal Quality Audits....................................................................................................................20
6.18 Training............................................................................................................................................21
6.19 Servicing..........................................................................................................................................21
6.19.1 Customer Service..............................................................................................................21
6.19.2 Field Service......................................................................................................................22
6.20 Statistical Techniques......................................................................................................................22
7.0 Organization Chart.....................................................................................................................................23

Rev x.xx DD/MM/YY
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

Rev x.xx DD/MM/YY
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]

Rev x.xx DD/MM/YY
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 Maintenance
Quality 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;

Rev x.xx DD/MM/YY
 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 Policies
Tier 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.

Rev x.xx DD/MM/YY
[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.

Rev x.xx DD/MM/YY
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:

Rev x.xx DD/MM/YY
 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.]

 Production Document Standards
 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.

Rev x.xx DD/MM/YY
[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

Rev x.xx DD/MM/YY
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.]

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.]

 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:

Rev x.xx DD/MM/YY
 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
 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
 Statement regarding inspection prior to use;

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

Rev x.xx DD/MM/YY
 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
 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
 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.]

 In Process Inspection
 Final Inspection
 Product Release
 First Article Inspection
 Acceptance Sampling Plans
 Stop/Resume Work/Shipment
 Quality Records
 Traceability

Rev x.xx DD/MM/YY
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.]

 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.]

Rev x.xx DD/MM/YY

 Sterilization Qualification and Control
 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.

 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

Rev x.xx DD/MM/YY
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
 Customer and Regulatory Audits
 Stop/Resume/Work/Shipment
 Correction or Removal of Marketed Products
 Quality Records
 MDR/MDVS Reports
 Returned Product Authorization, Evaluation, and Disposition

Rev x.xx DD/MM/YY
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.]

Rev x.xx DD/MM/YY
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.]

 Material Control Process

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
 Quality Records
 In-process Inspection
 Final Inspection
 Controlled Environments: Airborne Particles
 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
 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

Quality Manual

Încărcat de

Informații document

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Quality Manual

Încărcat de

Drepturi de autor:

Formate disponibile

[Company Name]

[Company Group, Division, Location]

Document Title: Quality Manual

CONTROLLED COPY/ MASTER COPY

Revision Revision DCO/ECO Revision

COMPANY PROPRIETARY AND CONFIDENTIAL

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

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

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

Table of Contents (cont.)

6.10 Inspection and Testing.....................................................................................................................12

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

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 23

[Insert the company history here]

2.2 Company Contact Information

[Insert company address here]

Other operating units include:

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 3 of 23

5.0 Quality Policy and Mission Statement

5.1 Quality Policy

5.2 Mission Statement

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 4 of 23

6.0 Quality System Requirements

6.1 Management Responsibility

6.1.1 Standard Operating Procedures

6.2 Quality System

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 5 of 23

6.2.1 Quality System Documentation Organization

[Insert a description of the Product Documentation here. Include the following

6.2.2 Standard Operating Procedures

6.3 Contract Review

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 6 of 23

6.3.1 Standard Operating Procedures

6.4 Design Control

6.4.1 Program Management

[Insert control of program management policy/procedural requirements and

6.4.2 Design Input

6.4.3 Design Output

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 7 of 23

6.4.4 Design Verification and Validation

6.4.5 Standard Operating Procedures

6.5 Document and Data Control

6.5.1 Organizational Document Release and Control

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 8 of 23

 Unique name and control number

Master organizational document and data lists identifying level of approval,

6.5.2 Departmental Document Release and Control

6.5.3 Document and Data Changes

 Who is responsible for reviewing and approving revisions or modifications to

6.5.4 Standard Operating Procedures

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 9 of 23

[Insert purchasing policy/procedural requirements and responsibilities here. Discuss the

6.6.1 Evaluation of Suppliers, Contractors, and Consultants

6.6.2 Purchasing Data

 Part number, description, quantity, grade, or other precise identification;

6.6.3 Verification of Purchased Products

6.6.4 Standard Operating Procedures

6.7 Control of Customer Supplied Product

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 10 of 23

[Insert control of customer supplied product policy/procedural requirements and responsibilities

 The disposition of lost or damaged product;

6.7.1 Standard Operating Procedures

6.8 Product Identification and Traceability

[Insert product identification and traceability policy/procedural requirements and