INTRODUCTION

Two of the most important objectives of the ISO

9001:2008 :
1. To develop a simplified set of standards that will be
equally applicable to small as well as medium and
large organizations
2. For the amount and detail of documentation required
to be more relevant to the desired results of the
organizations process activities.

ISO 9001:2008 Documentation

Requirements
Clause 4.2.1 General explains that the quality management system
documentation shall include:
1) Documented statements of a quality policy and quality
objectives;
2) A quality manual
3) Documented procedures required by this International Standard
4) Documents needed by the organization to ensure the effective
planning, operation and control of its processes
5) Records required by this International Standard

ISO 9001:2008 Documentation

Requirements
1) Documented statements of a quality policy and quality
objectives
-Requirements for the quality policy as per clause 5.3 of ISO
9001:2008
& requirements for quality objectives as per clause 5.4.1 of ISO
9001:2008.
- The documented quality policy has to be controlled according to the
requirements of clause 4.2.3. & The documented quality objectives
as per clause 4.2.3.

ISO 9001:2008 Documentation

Requirements
2) Quality Manual
- Requirements for the Quality Manual as per Clause
4.2.2 of ISO 9001:2008 & the document has to be
controlled in accordance with the requirements of clause
4.2.3.

ISO 9001:2008 Documentation

Requirements
3) Documented procedures:
ISO 9001:2008 specifically requires the organization to have
documented procedures for the following six activities:
- 4.2.3 Control of documents
- 4.2.4 Control of records
- 8.2.2 Internal audit
- 8.3 Control of nonconforming product
- 8.5.2 Corrective action
- 8.5.3 Preventive action

ISO 9001:2008 Documentation

Requirements
4) Documents needed by the organization to ensure the
effective planning, operation and control of its processes
Examples may include:
-Process maps, process flow
charts and/or process descriptions
-Organization charts
-Specifications
-Work and/or test instructions
-Documents containing internal
communications

-Production schedules
-Approved supplier lists
-Test and inspection plans
-Quality plans/Manufacturing Procedure

ISO 9001:2008 Documentation Requirements

5) Records
Examples may include:

1.Management review records

2.Records of personnel education,
training, skills, and experience
3.Records demonstrating that the
products (and realization processes)
meet all customer and legal
requirements.
4.Records of the review of product
requirements prior to realization
5.Supplier evaluation and selection
records
6.Validation of process for production and
service provision records
7.Product Identification and traceability

8.

Records of loss or damage to customer property

9. Calibration verification
10.Internal audit records
11.Records of product conformity to requirements and
release to customer
12.Records of Nonconforming products
13.Corrective action records
14.Preventative action records

ISO 9001 Documentation

Requirements
In conclusion, ISO 9001:2008 requires only 7
documents:
Quality Manual
Control of Documents Procedure
Control of Records Procedure
Control of Nonconformance Procedure
Internal Audit Procedure
Corrective Action Procedure
Preventive Action Procedure

Example of QMS Documentation

Master Document Register
QMS Master list Document