October 2004
A Standard Quality Management System?
The introduction of ISO 9001:2000 was supposed to herald the arrival of a common standard for quality management systems. Has this been achieved?
As the demand for a more practical and business approach to quality management systems grew in the 1990’s, so did the move towards a process-based approach. This approach placed less emphasis on the procedures and more on the application of a customer focused approach to continuous improvements. The result of this was the introduction of the new family of ISO 9000 standards and the role out of ISO 9001:2000.
The change was generally well received and accepted as the single standard that could be adopted and understood by all.
Examples include:
- TS 16949 – Automotive
- AS9100 - Aerospace
- TL 9000 – Telecommunications
- TickIT – Software and Applications
There are also variants for the medical sector whilst the food industry use supplier imposed systems.
Additional Requirements
Each of these sector specific standards are based around the core ISO 9001:2000 standard with additional requirements. The Automotive standard calls for detailed work on failure mode effect analysis (FMEA) and measuring system analysis (MSA) whilst the aerospace industry requires a detailed configuration management system.
Why is this so? Why do we need extended systems?
The simple answer seems to be that ISO 9001:2000 works well for the majority of organisations but not so well for those that are involved in complex and high risk industries. The more complex the product and process and the higher the risk associated with a systems failure then the more likely it is that sector specific requirements will be placed on all organisations within that supply chain.
Many companies believed that the new standard would enable them to move away from the need to comply with multiple systems and work with a process orientated management control system. Unfortunately, the additional requirements imposed by the specialist sectors tend to be compliance based rather than process based, i.e. they must be done in a specified way. If you only work in one industry then this may still be manageable, but for the precision engineer who supplies into the automotive, aerospace and medical sectors then life for the customer and quality managers has not got any easier!
If you are battling with the conversion of your system to meet the specific requirements of TS16949 or AS9100 and could use a quick and simple gap analysis of your system against the more specific standards then please contact Steve Stones via email or on 024 76 279 000.
Print this page