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 other sections would be targeting corporate customers, business partners, internal and external auditors, etc., while the ISO 9001 quality manual focuses directly on employees.
It is this quality manual that discloses how the prerequisites of ISO 9001:2008 are implemented by acting as a central resource. It also demonstrates how organization processes interact, and how they are controlled to deliver consumer 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 quality manual needs to be compiled to define every standard requirement. This is the primary requirement of ISO 9001.The latest version of ISO 9001:2008 provides a generalized framework that outlines how an organization should set about the task of meeting customer requirements and achieving satisfaction.Keeping the same standard in mind, the ISO 9001 quality manual should be capable to address the following:
- The range and scale of 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
- A brief overview of the documentation structure used in the quality management system.
What the manual can exclude?
It is essential to look into the permissible exclusions allowed by the standard when preparing your ISO 9001 quality manual.With proper justification within the manual, all exclusions need to be properly documented.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.Paragraph 7.6 can be permitted as an exclusion if the organization is not involved with equipment calibration.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.Thus, paragraph 7.3 of ISO 9001 is not applicable to our business as our QMS does not encompass product design and development processes.
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