The Standard in Quality and
Environmental Consulting
Since 1985.
The Standard in Quality and
Environmental Consulting
Since 1985.
Compliance with Multiple\Sequential Standards
Many companies find themselves needing to comply with multiple/sequential standards, for instance, ISO 9001 and EN 46001 for the medical device manufacturer, and ISO 9000 and AS 9100 or QS 9000 for aerospace or automotive manufacturers respectively. As EN 46000, AS 9000 and QS 9000 are all based upon ISO 9000, it is often considered a valid approach to achieve ISO 9000 compliance first and then upgrade the system to be compliant to the other, additional standard at a laterdate. While this sounds like a sensible stepping stone for a multiple stage system, there are often reasons why this does not make sense. The additional requirements placed on suppliers by these other standards are often the specific elements that customers, the motivation behind the implementation, are interested in. It is in this area that customers are going to show greater interest. What's more, the supplier is often complying with the customers requirements anyway and may be closer to compliance than they thought. Then there are the problems and costs associated with splitting the project into two or more stages that will add complexity and delays completing the total project. In most cases it simply does not make sense to put off compliance with the ultimate goal.
Another common situation occurs when companies are required to comply with the requirements of different "customers". One frequent example would be a company who sells medical devices to the US and to Europe and thus needs to comply with the differing requirements of the Medical Device Directive (MDD) and FDA cGMP. The important issue here is to ensure that only one system is developed. The system will encompass the requirements of both regulations and a single system is implemented to satisfied the combined requirement. It may be necessary to implement case-specific activities or generate case-specific documentation, but typically these are minimal.
Another example, which will become much more common as the environmental regulation authorities use this proactive technique for control, are the combination of ISO 14000 the environmental management system requirements, with ISO 9000 (or one of the many variants) into a single comprehensive management system.
Cavendish Scott advocates the combination of management-system requirements into a single system to comply with as many regulations, standards, and requirements as needed. This ensures a consistent approach that is easy to learn and understand by staff and minimizes project and maintenance costs.
Also See
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Services and Standards Index |  |
The Cavendish Scott Approach |
