There are specially trained people who do quality performance checking on the management systems that industry has in place. These people are auditors and they work in auditing industry. Auditors check for safety and problems that can occur from the result of poor responsibility and poor application. It is the job of the ISO 9001 auditor to do this kind of checking.
A formal statement must be made by the management of a business of a quality policy and an auditor will check this. Items that must be closely tied to this statement are any plans relating to business, marketing and requirements of customers. Where there are employees they have to understand this statement and be able to work towards some kind of objective.
Auditing must be done on a regular basis to make sure the quality system is evaluated to see how it conforms and how effective it is. To be able to make any decision on the quality system, this is done on the data that has been previously recorded.
This process of auditing helps to track products when any problem occurs in any part of a system. It can help to go back to where any raw materials have been processed and the way any products where made. This can also be helped by the information on the place they were purchased or where they came into the system.
There is a need to develop good communications and know customers requirements. This has to go right back through the line from information about products, enquiries they may have, products that are ordered and any complaints and feedback good or bad. The auditors need to check that this is in place and working. Where there is development of a new product, the business has to plan the development in stages. Correct testing needs to be done at each stage. The product when tested is documented as to whether it does or does not meet the design and regulation requirements and the needs of the user.
The performance of the business being audited needs to be regularly reviewed. Is the quality system working, can it be improved and have problems in the past been dealt with and if there is a potential problem has this also been dealt with. Monitoring and recording of all these types of activities must be written down and this is done with internal and external auditing.
There has to be a documented procedure for the handling of a problem of non conformance or a potential for this to happen, anywhere in the system. Poor products are not to be used, where any are found they must determine what to do with them, where they came from, fix the problem and keep records so the system can be improved. An ISO 9001 auditors job is to cover all aspects of this particular system.