Top 5 questions about your 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 ISO 9001 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 quality 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 manual 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 quality 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 quality 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 ISO 9001 quality manual and the purpose and scope of the procedures. The quality manual 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.
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 quality 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.
Compilation of the ISO 9001 quality manual can be challenging task as it tends to be a key information resource to multiple audiences. By using a consistent approach to content input and formatting, it becomes much easier to communicate to those audiences about your organization’s approach to quality.
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