iso9000, iso9000:2000, iso14000, iso9000 Explained, Centre for ISO9000

Clause	Control of:	Meaning
4	Quality Management System
4.1	General Requirements	You must have a quality system which is kept up to date and continually improved. This clause requires that you : identify the processes involved, determine the sequence of operations, determine ways by which you can be sure that the processes are working correctly, ensure that you have sufficient resources for the processes and their monitoring can show that you monitor and improve your system The details of how you much meet each of these requirements are given in the following sections of my explanation of ISO9001:2000.
4.2	Documentation Requirements
4.2.1	General	This clause defines that the types of documentation that you must include in your system: statements of quality policy and quality objectives A Quality Manual (but, it doesn't state what a "Quality Manual" actually is!) documented procedures, where required by the standard (see later on for an overview of when procedures are needed and when they are not) the records required by the standard to prove that you meet its requirements, plus any others that you decide that you need, in order to operate your business properly A note in this section acknowledges that the extent of your documentation will depend upon your processes, competence of personnel
4.2.2	Quality Manual	You must have an up to date Quality Manual, which addresses the following requirements. Your Quality Manual must include details of any the reasons why you think any clause of ISO 9001 does not apply to your organisation. (Remember that only sub-clauses of Clause 7 can be excluded). It should include the procedures that are required by ISO 9000 (see below), or else it must have references to those procedures. Please note that this does not mean that you must put everything into one huge book. You can keep the procedures separate from the policy level manual, and have separate collections of SOPs, Work Instructions, etc. (It is usually a BAD IDEA to put them all together in one huge collection. No-one can find what they need.) It should define the interaction between the various processes. (This can be by diagrams - e.g. flow charts, etc - or in words.
4.2.3	Control of Documents	You must ensure that only the correct version of documents is available for use. They must be reviewed and approved prior to use. You should know what documents exist and which version is the correct one. You must periodically review them for ongoing suitability (are they still legible, relevant, etc). You must have a procedure to control these activities
4.2.4	Control of Records	You must make sure that you keep sufficient records to prove that you are operating your quality management system correctly. You must keep them for a defined minimum period. You must keep them in good condition, in such a way that they can be easily found. This clause requires that you have a procedure which ensures that quality records are suitably controlled with regard to: defining what records are required, how & where they are stored, ensuring that they can be retrieved, describing their retention time and subsequent disposal You must have a procedure to control these activities