iso 9001 consultants
quality management systems consultants
Most organisations, if they have been successfully in business for a number of years, must have some management systems and processes in place and although these may be very informal, probably meet (or nearly meet) many of the requirements of ISO 9001. My approach is to concentrate on these established processes, documenting where necessary (and only where necessary!) and adding mandatory ISO 9001 requirements where these are absent. My very first activity will be to conduct a ‘gap analysis’ to determine exactly where my time would be best spent. This is somewhat different to the approach offered by some ‘consultants’ who will sell you an offthe-shelf ‘Quality Manual’ (that presumably meets ISO 9001 requirements but having seen a few in recent years this is not always the case). They then provide a set of standard forms (some of which you will already have your own versions of) and then leave you to ‘get on with it’.
My approach involves holding a client’s hand and literally walking through every requirement and process and providing a solution that they will be happy to wholeheartedly adopt. Typically, a large part of my involvement is implementing the ISO 9001 activities that they have not previously considered and probably have not got any current processes for e.g. corrective action, calibration and internal auditing to name but a few. I offer a variety of solutions for each of these processes (based on previous successful systems in other client companies) and let the client make their choice. For example, to cover recording of corrective action I would offer spreadsheet and database based systems and let the client choose. The chosen system would then be ‘customised’ to sit alongside the client’s other systems.
I will offer to conduct the first cycle of internal audits and also offer to steer (but not chair) the initial management review (these offers are almost always taken up). Using the above approach over the last fifteen years has resulted in a 100% success rate of first-time passes at the certification audit.