ISO 9001 - Lessons learned
Anyone who has been involved with ISO 9001, or its predecessors, for some time will have learned a lot through hard experience, and there is no doubt that ISO 9001 has been used and abused in many ways since its birth. There have always been, and probably still are, misconceptions as to what it is and how it should be implemented.
The following are just a few of the more common misconceptions or lessons learned through the experiences of implementing an ISO 9001 Quality Management System.
Frequent Misconceptions about ISO 9001
ISO9001 has often, in the past, been regarded as something that sits outside the real day to day business, whereas it should in fact provide the framework on which a business operates and improves.
Registrations to ISO 9001 have sometimes been achieved by simply bringing existing processes into line with ISO 9001 requirements. Although this approach has often met the basic requirements of ISO 9001, it would not have necessarily put in place the means to improve performance. Given the clear requirement in ISO 9001:2000 for "Continuous Improvement", it should not theoretically be possible to gain certification without effectively addressing this issue.
It is not uncommon for staff who have not been directly involved in an ISO 9001 implementation to view any new procedures introduced by virtue of the exercise as somehow separate from the normal operating procedures. They are frequently referred to for example as the "Quality" or "ISO" procedures. This means they have misunderstood the motives for implementing the Quality Management System.
The Management Reviews required by ISO 9001 are often regarded as only being about the so-called "quality procedures" that probably did not previously exist - e.g. Internal Audits, and Document Control procedures etc. The requirement is however for management to regularly review the functioning and effectiveness of the whole business using the results from various measures, and also to ensure that policies and objectives are still relevant and being met.
A common belief is that the management representative, often referred to as The Quality Manager, is the person solely responsible for the ISO 9001 system and the thing called "Quality". This should not be the case, the Quality Management System, whether ISO 9001 based or not, is everyone’s responsibility and this needs to be realised at an early stage.
If you want to just ask a question or two, or wish to discuss further how either ISO 9001 can help improve your business, then do contact.