1. Iso 9001 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 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
2. 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.'
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