Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to
It is clear that ISO 9001 is unclear don't you think? And here is the proof:
9001 Clause 4.2.1 requires the QMS documentation to include a quality manual, policy, objectives, procedures records and process documentation. (but excludes process interactions and org charts )
9001 Clause 4.2.2 defines what is to be included in the 9001 quality manual - scope, procedures, description of process interactions (but excludes policy, objectives and records, org charts and process documentation)
9000 Clause 3.7.4 defines what a quality manual is - simply a document specifying the QMS which could be all of the above (in engineering terms; all the specs, drawings, schedules, instructions to implement and operate the QMS)
9000 Clause 3.7.2 says "that documents that provide consistent information, both internally and externally, about the organization's quality management system; such documents are referred to as quality manuals;" So this might be anything
9000 Clause 3.3.2 says "A formal expression of the organizational structure is often provided in a quality manual" (Hence why clause 4.2.2 is not limiting
9000 clause 3.7.5 says "A quality plan often makes reference to parts of the quality manual" Implies the manual is a reference document.
Neither ISO 9000 nor 9001 imply or require the quality manual to include or even refer to the requirements of ISO 9001. These standards also do not require a quality policy that expressses a specific commitment to meet the requirements of ISO 9001. A commitment to meet requirements yes, but these are customer and regulatory requirements.
When you approach the development of a QMS from the direction of ISO 9001 you will run into the type of problem we are debating. If you approach the development of a QMS from what the business needs in order to consistently produce product that meets customer requirements, you only get around to looking at ISO 9001 after you have a capable system and want independent certification. By that time you will have a system description that fulfils a business need and this you can present as your quality manual be it one page, or 5000 pages. The business drives the QMS not ISO 9001, this is simply an assessment standard as is clearly stated in clause 0.1. It does not say that ISO 9001 can be used to develop a QMS.