Monday, 18 October 2010

Adding Quality to your ISO 9001 Quality Manual

Adding Quality to your ISO 9001 Quality Manual

Every customer expects value for money when purchasing any product, and in accordance with this; organizations understand that operating an efficient quality management system will help to ensure these expectations are realised. It is therefore no surprise that your ISO 9001 quality manual is at the heart of any effective quality management system.

By acting as a centralised resource for information such as policies, objectives and procedures, the ISO 9001 quality manual demonstrates an organization’s approach to delivering customer satisfaction.

Who uses your ISO 9001 Quality Manual?

The ISO 9001 quality manual contents will be directly relevant to employees, whilst other sections will be more relevant to corporate customers, business partners or internal and external auditors.

The quality manual reveals how the requirements of ISO 9001:2008 are implemented by acting as a central resource that demonstrates how an organization’s processes interact and how those processes are controlled in order to deliver customer satisfaction.

The quality manual is also useful in helping to communicate management's approach to the application and incorporation of quality management principles into the organization’s daily activities.

What must be Included in your Manual?

ISO 9001 requires an organization to compile an ISO 9001 quality manual in order to define how each requirement of the standard will be applied. The latest version of ISO 9001:2008 provides a generalised framework that outlines how an organization should set about the task of meeting customer requirements and achieving satisfaction. Based on this standard, the ISO 9001 quality manual should address the following:

- the scope of the QMS
- details of and justification for any exclusion or non-application
- references to the documented procedures
- a description of interaction between the processes of the QMS
- an outline of the structure of the documentation used in the quality management system

What can be Excluded from your Manual?

It is essential to look into the permissible exclusions allowed by the standard when preparing your ISO 9001 quality manual. All the exclusions must be properly documented within the manual by giving appropriate justification. Exclusions from section 7 - Product Realisation, are permitted as long as the exclusion does not adversely impact an organization's ability to meet the requirements of its customers.

Only activities that an organization does not do itself can be considered as permissible exclusions. For example, if an organization does not design; this is a permissible exclusion. If an organization does not use equipment requiring calibration, then paragraph 7.6 is a permissible exclusion. In order to exempt one’s self from a requirement, a statement such as the following would suffice:

‘Company XYZ does not engage in designing, developing or changing the design of the products we manufacture. Therefore, our QMS does not encompass product design and development processes and paragraph 7.3 of ISO 9001 is not applicable to our business.


Download a free ISO 9001 quality manual template example courtesy of ISO 9001 Checklist.

The quality manual is ideal for organizations that require an affordable, basic manual that will satisfy the requirements of ISO 9001 whilst providing a framework for a formal in-house quality system. To learn more please visit ISO 9001 Checklist: