[Company Name]

[Company Group, Division, Location]

Document Title: Quality Records

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/ YY-00000 Draft Author Name
YY
1.00 DD/MM/ YY-00000 Initial Release Author Name
YY

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

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

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

3.0 Definitions.....................................................................................................................................................3
3.1 Design History File (DHF).................................................................................................................3
3.2 Device History Record (DHR)...........................................................................................................3
3.3 Device Master Record (DMR)...........................................................................................................3
3.4 Controlled Copy.................................................................................................................................3
3.5 Controlled Document.........................................................................................................................3
3.6 Uncontrolled Copy.............................................................................................................................3
3.7 Quality Records..................................................................................................................................3

4.0 Responsibilities.............................................................................................................................................3
4.1 Quality Assurance..............................................................................................................................3
4.2 Document Control..............................................................................................................................3
4.3 Departmental Manager.......................................................................................................................4
4.4 [Company Name] Employees............................................................................................................4

5.0 References and Applicable documents.........................................................................................................4

6.0 Procedure......................................................................................................................................................4
6.1 Quality Record Requirements............................................................................................................4
6.2 Approval/Control/Retention...............................................................................................................4
6.3 Document Users.................................................................................................................................5
6.4 [Company Name] Device Master Record Requirements...................................................................5
6.5 [Company Name] Device History Record Requirements..................................................................5
6.6 [Company Name] Design History File Record Requirements...........................................................5

Table of Figures
Table 1. Document Matrix Legend...........................................................................................................6
Table 2. Document Matrix........................................................................................................................6

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 7

[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
To ensure that all quality records pertinent to the quality system and products are maintained and
managed effectively, and to provide objective evidence of quality system implementation.

2.0 Scope
This procedure applies to all quality records for the operation of the quality system at all facilities of
[Company Name].

3.0 Definitions

3.1 Design History File (DHF)

A compilation of documents that describes the design history of a finished device.

3.2 Device History Record (DHR)

A compilation of documents containing the production history of a finished device.

3.3 Device Master Record (DMR)

A compilation of documents containing the procedures and specifications for a finished device.

3.4 Controlled Copy

A controlled copy is an exact copy of the original controlled document that must be maintained for
uniformity, process control, and tracking. It has limited and specific distribution, and the front
page is marked in red with "Controlled Copy". Document Control must issue any controlled
copies.

3.5 Controlled Document

A controlled document is the original document that must be maintained for uniformity, process
control, and tracking. There is one original for each document, instruction, procedure, standard, or
form. It may be maintained on paper, or as an electronic file. The master copy of any document is
the electronic file available for viewing on the network. Document Control maintains controlled
documents.

3.6 Uncontrolled Copy

Any copy of a document that is not controlled is an uncontrolled copy. An uncontrolled copy may
be used for informational purposes only. These documents may not be used for operation of the
quality system, manufacture of product, for accept / reject decisions on product or processes and
operation of quality related processes.

3.7 Quality Records

Records that demonstrate conformance to required and adequate operation of the quality system
herein referred to as documents.

4.0 Responsibilities

4.1 Quality Assurance

Decides which documents are quality records.

Quality Assurance ensures that all documents meet applicable standards.

4.2 Document Control

Maintains the "master copy" showing approvals and latest revision of documents that are
maintained by Document Control. Maintain a current list of released documents on the network.

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[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Notify Quality Assurance of any document(s) that is added to or removed from the Quality System
that is considered a quality record.

4.3 Departmental Manager

Notify Quality Assurance of any document or report that would be considered a quality record.

4.4 [Company Name] Employees

Identify obsolete versions of documents;

Recommend changes to documents;

Prevent unauthorized copying or amendment of documents;

Not to obtain or use documents other than [Company Name] documents.

5.0 References and Applicable documents

Document Retention, Storage and Disposition
Engineering/Production Document Release and Change Control
Design History File

6.0 Procedure
The majority of all documents are uploaded to computer databases (BAAN and O:\Solidworks) through
electronic procedures for storage, filing, and archiving. The use of computerized storage ensures
legibility, retrievability and a suitable environment that minimizes damage and deterioration. Where
paper documents are utilized, the issuing department is responsible for the establishment and
maintenance of suitable procedures. Quality records shall be made available for evaluation for an agreed
period to a customer when agreed contractually.

6.1 Quality Record Requirements

All documents must be legible.

All paper documents that require information to be filled out must be completed in blue or black
ink. NO PENCIL is permitted. NO RED or colored ink other than mentioned above may be used.

If a mistake is made on a paper document, the mistake shall be crossed out with a single line,
dated and initialed.

6.2 Approval/Control/Retention
A list of quality records is identified in the document matrix. Documents not appearing or referred
to on this list are not quality records and are not governed by this procedure.

Incorporation of external quality related standards into the quality system requires written
approval by the Quality Assurance Manager.

The document matrix indicates the Controller of the document/data. This person/department
manager is responsible for approval and updating documents and records.

Document control will notify affected departments of document and records changes.

Retention period requirements of documents are based on business and regulatory requirements.

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[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

6.3 Document Users

Documents must not be changed without the controllers consent.

Users cannot deface, amend, destroy, add or delete information to documents.

Document users are required to destroy or return obsolete versions of paper documents once
revised.

6.4 [Company Name] Device Master Record Requirements

[Company Name] will maintain a device master record for each device manufactured with the
following contents: (Refer to document matrix)

6.5 [Company Name] Device History Record Requirements

[Company Name] will maintain a device history record for each device manufactured with the
following contents: (Refer to document matrix)

6.6 [Company Name] Design History File Record Requirements

[Company Name] will maintain a design history file record for each device manufactured with the
following contents: (Refer to Design History File)

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[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table 1. Document Matrix Legend

Abbreviatio Meaning
n
ADMN Administration
DC Document Control
DPML Departmental
ENG Engineering
HR Human Resources
MANF Manufacturing
ME Manufacturing Engineering
MTN Maintenance
PM Program Management
PURC Purchasing
QA Quality Assurance
QA MGR Quality Assurance Manager
QS Quality Systems

Table 2. Document Matrix

Part Part of
Document Maintained Controlled of Retention Period
Name By By DMR DHR (Minimum)
Approved Supplier List PURC QA 3 years
Archival Records: ADMN/DC ADMN/DC Permanently
Admin/Document Control
Artwork DC ME or ENG * Product Life + 2
years
Audit Checklist QA QA Continuing
Audit Summary Reports QA QA 2 years
Calibration Procedures QA QA * Product Life + 2
years
Calibration Record QA QA * Product Life + 2
years
Cleanroom Cleaning Checklist MANF ME 5 years
Complaint Analysis Form QA QA Product Life + 2
years
Complaint Log QA QA Permanently
Component Specifications DC ENG * Product Life + 2
years
Contracts/ Modifications ADMN ADMN Permanently
Controlled Environment Monitor MANF ME 5 years
Log
Corrective Action Notice QA QA 2 years
Customer Complaint Form QA QA Product Life + 2
years
Daily Receiving Log PURC PURC 5 years
Daily Shipping Log PURC PURC 5 years
Document Approval Record DC DC 5 years
Drawings DC ME or ENG * Product Life + 2
years
Engineering Change Order DC ME, ENG, Product Life + 2
PM or QA years

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[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Part Part of
Document Maintained Controlled of Retention Period
Name By By DMR DHR (Minimum)
External Audit Records QA MGR QA 5 years
Hepa Air Velocity Measurement MANF ME 5 years
Log
Incoming Inspection Report QA QA * Product Life + 2
years
Inprocess Inspection Log QA QA * Product Life + 2
years
Inspection Procedures DC QA * Product Life + 2
years
Internal Audit Records QA QA 5 years
Internal Auditor List (ISO) QA MGR QA Continuing
Lab Notebooks DC ENG Product Life + 2
years
Management Review Reports QSM QSM 2 years
Manufacturing Procedures DC ME * Product Life + 2
years
Manufacturing Process DC ME * Product Life + 2
Procedure/Specifications years
Marketed Product Correction and QA QA 5 years
Removal Form
Master Calibration List QA QA Continuing
Material Disposition Sheet DC DC * Product Life + 2
years
Material Review Report QA QA * Product Life + 2
years
MDR Event Report Log QA QA 5 years
MDR Reports QA QA Product Life + 2
years
Medical Device Report Analysis QA QA Product Life + 2
Form years
Medical Device Report Event QA QA Product Life + 2
Form years
Mold, Fixture, Jig Certification QA ME * Lifetime of Tool +
Record 2 years
Non-Product Specific Work DPML DPML Per Department
Instructions
Order Entry Form ADMN ADMN 5 years
Organizational Charts HR HR Continuing

Parts List/BOM DC ENG or ME * Product Life + 2

years
Preventive Maintenance ME ME * 2 years
Workorder
Process Specification DC ENG * Product Life + 2
years
Process Validation Records QA QA * Product Life + 2
years
Product Release Verification QA QA * * Product Life + 2
years
Product Description DC PM * Product Life + 2

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[Company Name] Quality Records
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Part Part of
Document Maintained Controlled of Retention Period
Name By By DMR DHR (Minimum)
years
Product Manuals/Labeling DC ENG * Product Life + 2
years
Product Requirements DC PM * Product Life + 2
Document(Functional Specs) years
Product Travelers QA ME * * Product Life + 2
years
Product Tree DC ENG * Product Life + 2
years
Project Management Plans DC PM Product Life + 2
years
Purchase Orders PURC PURC 7years,
Purchase Requisition PURC PURC 7 years
Quality Manual DC QA MGR Continuing
Quality Trend Reports QA QA 2 years
Quotation Form ADMN ADMN 5 years
Returned Material Authorization QA QA 5 years
Request
Returned Product Form QA QA 5 years
Schematic DC ENG or ME * Product Life + 2
years
Scrap Report QA MGR QA 2 years
Software Problem Report ENG ENG 5 years
Software Release DC ME or ENG * Product Life + 2
years
Source Code DC ME or ENG * Product Life + 2
years
Stock Purge Request PURC PURC Product Life + 2
years
Supplier Evaluation QA MGR QA 2 years
Technical Report PM PM Product Life + 2
years
Temporary Calibration QA QA Lifetime of
Extensions Equipment + 1
year
Test Procedure DC ME * Product Life + 2
years
Test Specification DC ME or ENG * Product Life + 2
years
Training Exemption ADMN ADMN Permanently
Training Record ADMN ADMN Permanently
Vendor Authorization Request PURC QA 3 years
Vendor History Form QA QA * Product Life + 2
years
Vendor Notification Report QA QA 5 years
Workmanship Standard ME QA * Product Life + 2
years

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