4

Quality Management System

4.1

General requirements

A definition of the processes necessary to ensure that a product conforms to customer requirements and that they are capable of being implemented, maintained and improved.

• Core Business Processes supplemented by:

  • Supporting Processes;

  • QPs;

  • WIs.

4.2

Documentation requirements

4.2.1

General

Documented proof of a Quality Management System.

• Quality Manual.

• High level policy statement on organisational objectives and quality policy.

• Procedures.

• Quality records.

4.2.2

Quality Manual

A document which describes an organisation's quality policies, procedures and practices that make up the QMS.

• A Quality Manual containing everything related to quality controls within an organisation.

4.2.3

Control of documents

How an organisation's documents are approved, issued, numbered, etc. How revisions are recorded and implemented and obsolete documents removed.

• Document control procedures.

4.2.4

Control of records

What quality records need to be kept to demonstrate conformance with the requirements of an organisation's QMS and how they are identified, stored, protected, etc.

• Record keeping procedures.

5

Management responsibility

Management responsibility and quality requirements.

• Quality Manual.

5.1

Management commitment

A written demonstration of an organisation's commitment to:

• sustaining and increasing customer satisfaction;

• establishing quality policies, objectives and planning;