ISO9001:2008 Requirements Overview

Overview of ISO9001:2008 Requirements

ISO 9001 requirements can be grouped into 5 main clauses:

4.0 Quality Management Systems
5.0 Management Responsibility
6.0 Resource Management
7.0 Product Realization
8.0 Measurement, Analysis and Improvement

We shall follow all the requirements stated in each clauses. However, Exclusions is given (limit to clause 7) due to nature of organisation's product, customer reuqirements, applicable requlatory requirements.

This exclusion does not absolve the organisation of responsibility to provide product and /or services which meets customer and regualatory requirements.

Documentation Requirements
ISO 9001 require a set of document we must prepared for our people to follow and audit, the mininum requirement for doumentation are list below:

1. Documented statements of a Quality Policy and Quality Objectives.
2. A Quality Manual.
3. Documented Procedures required in this Int’l Std.
4. Document required by the organization to ensure effective operation control of its processes.

(refer ISO9001:2008 clause 4.2 Documentation Requirement)
 To implement this, you must have a document call "Quality Manual", inside the "Quality Manual" it must have Quality Policy and Quality Objective. Quality Mamual also need to include the Business Scope, and the linkage of each related procedures. (refer to ISO 9001:2008 clause 4.2.2 Quality Manaul)

Beside the Quality Manual, you are also require to prepare Quality Procedure, six Quality Preocedures are MUST be include, there are:

1. Control of Document Procedure
2. Control of Quality Record Preocedure
3. Control of Non-Conforming Product Procedure
4. Corrective Action Procedure
5. Preventive Action Procedure
6. Internal Audit Procedure

Below are the formal structure for to establish your document structure.