1. Iso 9001 quality manual
An ISO 9001 quality manual details how an organization will actively ensure customer
satisfaction through the application of established quality management principles. For
this reason, the quality manual is one of the most scrutinised high-level documents
present in an organization. This article discusses a number of issues surrounding the
format and content of the manual.
Format & Content
There are no requirements defining the format of the ISO 9001 quality manual, most
organizations often use a pre-formatted template which is easily modified as the quality
system develops. Using a quality template will afford an organization more time to focus
on documenting systems and processes with greater accuracy during the implementation
phase.
There is often considerable debate about the format and content of the manual. The
balance of opinion is divided between those who believe the manual's format does not
matter, as long as, what occurs out in the field complies with the requirements and those
who believe the quality manual should say something 'personal' about the organization's
approach to quality management.
It would be true to say that every company has their own style of operation which will
inevitably be reflected in the manual and procedures. This variance is fine; all that
matters is that the quality manual and procedures are able to respond positively to these
questions:
1. Does it define the scope of the organization's approach to quality management?
2. Does it define how the scope is applied?
3. Does it give suitable reason for permissible exclusions from that scope?
4. Does it contain, or make reference to, documented procedures?
5. Does it ensure a cycle of feedback exists to allow improvement?
It is important to maintain a clear distinction between the contents of the manual and the
purpose and scope of the procedures. The QMS should define top management's intent to
operate an effective quality management system, while the procedures define how those
intentions will be implemented at an operational level.
2. The quality manual should not be over burdened with excessive detail which requires
frequent change to ensure relevance is maintained. The approach taken many companies
to avoid over-burdening their manual is by allowing lower-level documents, such as
procedures and work instructions to contain operational detail. Then, simple reference is
made to the procedures and work instructions from within the manual itself. In other
words, let the procedures take the strain of controlling day-to-day activities; after all, they
are 'working' documents the organization uses to achieve the goal of customer
satisfaction.
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