Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 1 of x

ISO Procedure

Quality Records
Approved:
title

__________________________________________________
Name

Approved:
___________________________________________________
title Name

Approved:
title

__________________________________________________
Name

Approved:
title

__________________________________________________
Name

Approved:
title

__________________________________________________
Name

Change Record Rev A Date Responsible Person Name Description of Change Initial Release

Distribution List (list the departments that receive controlled copies)

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 2 of x

1.

Purpose To retain quality records for a period specified. To identify the storage of quality records that protects them from damage and facilitates retrieval through identification collection, indexing, and disposition. To ensure that records are legible, dated (including revision dates), clean, identifiable, and maintained in an orderly manner.

2. Scope

This procedure applies to all records affecting quality and described in the ISO 9000 procedures. 3. Responsibilities <Job title> is responsible for maintain quality records as defined in this procedure.

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 3 of x

4.

Procedure 4.1 Storage Quality records are stored <location>. The length of time is determined by <job title> and indicated in the tables below. Quality Records are protected from damage as follows: <attribute> <attribute> <attribute>

Quality Records are protected from loss as follows: <attribute> <attribute> <attribute>

Quality Records are legible and readily retrievable. Where computerized, Quality records follow an established backup procedure. <Job title> is responsible for backing up the records. 4.2 Records The following tables list the Quality Record, where it is stored and length of storage. Inspection And Test Records Description Storage Area Length of Storage

Title

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 4 of x

Title

Traceability Data Description Storage Area

Length of Storage

Title

Contract Review Reports Description Storage Area

Length of Storage

Title

Design Review Records Description Storage Area

Length of Storage

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 5 of x

Title

Training Reports Description Storage Area

Length of Storage

Title

Nonconforming Product Reports Description Storage Area

Length of Storage

Title

Customer-supplied Product Reports Description Storage Area Length of Storage

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 6 of x

Title

Calibration Reports Description Storage Area

Length of Storage

Title

Process Qualification Data Description Storage Area

Length of Storage

Title

Equipment Verification Reports Description Storage Area

Length of Storage

Title

Management Review Reports Description Storage Area

Length of Storage

Controlled Copy, Do Not Duplicate

For Internal Use Only

Company Name Division or Address Division or Address

Quality Records Doc. No. Date: -

Rev. No. Page 7 of x

Title

Subcontractor Review Reports Description Storage Area

Length of Storage

Title

Corrective Action Reports Description Storage Area

Length of Storage

Title

Preventive Action Reports Description Storage Area

Length of Storage

Controlled Copy, Do Not Duplicate

For Internal Use Only