General Comments
Clause 4.2 covers the structure of the quality system of the organisation and its documentation.
Therefore a well-planned and managed quality system has to be defined and documented, which is dealt with by quality plans (e.g. which may include procedures, work instructions, as well as formal quality plans, etc) and quality manual sub-clauses. The quality system should be documented in enough detail so that employees, suppliers and customers can understand it and that it can be audited. (see Clause 4.17)
CLAUSE 4.2.1 - General
This clause requires that the Company has a Quality Manual as an essential part of the quality system. It also requires that the documented procedures are referenced from the Manual. This means that a Quality Manual is now mandatory and must reference all the operating procedures either directly from the text or through a cross reference matrix or table, etc.
CLAUSE 4.2.2 - Quality System Procedures
This clause requires that procedures are consistent with your Quality Policy and that they are appropriate to the level of complexity of the processes involved and the skills and training required.
Note : The documented procedures must be relevant to the stated quality policy.
Where a company can demonstrate through adequate training or other records the acquisition of skills/training by all relevant personnel, procedures can be less detailed; for example personnel who have achieved qualifications through apprenticeship schemes or through formal education, etc may not require detailed procedures or work instructions for those aspects of their work.
CLAUSE 4.2.3 - Quality Planning This clause requires that your company undertakes quality planning as appropriate to the needs of the Company and that this should be defined and documented.
Note : This does not necessarily mean that you must produce formal quality plans as separate documents. your procedures may be sufficient to be considered to fulfil the requirement for Quality Planning. The main thrust of the clause is that you must plan your work and document it in a relevant format.
