How to add quality to your ISO 9001 Quality Manual
It is not unusual for all consumers to expect the best value for money when buying a product. Organizations have grasped the fact that to ensure the expectations are met, it is essential to operate an efficient quality management system.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.
ISO 9001 Quality Manual is used by whom?
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.
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 helps incorporate quality management principles into routine organization activities and also helps communicate the management approach.
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.Based on this standard, the ISO 9001 quality manual should address the following:
- The range and scale of QMS
- If any non-application is to be addressed, its details and justification need to be addressed
- 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 vital to check all exclusions that are permitted by the standard while preparing the 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.
The activities that the organization doesn’t implement itself can only be a part of 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.A statement such as the below would suffice if an organization needs to exempt itself from requirement.
Company XYZ is not involved with the design or development of the products manufactured by us.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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