Quality Manual

Hi,

Is it necessary to have a Quality manual to fulfill ISO requirement?

In our company, we have a lengthy manual that covers each and all section of ISO.

Can we just replace it with flow chart that cover whole process and show supporting documents (or relevant record/log)?

Regards
MK

 

Now in this version, is not required , however some organizartions keep it, for training purposes or some others
because some customers still require it.

 

One of the reasons that organizations opted to use the structure of the standard for documenting their quality manual was the guidelines provided by the old ISO 10013:1995 (Guidelines for developing quality manuals). This standard mentioned in its section 4.2.2 this statement: "One of the methods of assuring that the subject matter is adequately addressed and located would be to key the sections of the quality manual to the quality elements of the governing quality system standard". Since then, up to present, many organizations are still documenting their QM based on the structure of the standard. This approach provides a convenient reference for both internal and external parties in understanding how the requirements of the standard are fulfilled. A lot of CB auditors prefer this because they can easily audit organizations against the clauses. They can even show off to auditees that they know better the contents of the auditees' QM - because the auditees created/documented their QMS from the perspective of the external auditors. So a clause-based QM is an auditor-friendly approach.

However, though the clause-based QM seems to promote "convenience" and an easy reference for CB auditors, the organizations and their process owners should be able to appreciate their QMS less from the clauses but more from the interrelated/interacting processes. In documenting a user-friendly quality manual, the statements in the more recent versions of the ISO standards should be considered:

• Introduction section of ISO 9001:2015 specified: "It is not the intent of this International Standard to imply the need for: alignment of documentation to the clause structure of this International Standard".
• Annex A.1 of ISO 9001:2015 clarified that: "The structure of clauses is intended to provide a coherent presentation of requirements, rather than a model for documenting an organization’s policies, objectives and processes. The structure and content of documented information related to a quality management system can often be more relevant to its users if it relates to both the processes operated by the organization and information maintained for other purposes".
• Clause 4.2.4.2 of the new ISO 10013:2021 (Guidance for documented information) recommended: "The organization should document its specific quality management system following the sequence of the flow of the processes..."

A quality manual that is structured against the processes may not be as "convenient" like the clause-based approach but can be a more valuable tool in establishing an integral QMS. I would prefer documenting a QM that will allow the organizations and their process owners to see ISO 9001 not as a standard that must be supported but as a reference that will support them instead. Thus, instead of documenting how the clauses are supported by the processes, I prefer to document how the processes are supported by the clauses.