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ISO Our Approach

Quality Management Systems- Our Approach:

The core of any Quality Management System is the overall Quality Manual. This effectively defines the way in which the system is implemented within the company. The various standards deliberately provides little guidance in how this should be structured saying only that it must include

  • The scope of the system and any justification for exclusions.
  • The documented procedures for the QMS or a reference to how to find them a description of how the processes work together.
  • A range of approaches can therefore be taken to satisfy the requirement

One extreme approach: Many companies (or consultants) chose to structure their Quality Manual around the standard itself. The resulting manual is effectively a copy of the standard and provides a point-by-point summary of how the system satisfies the individual requirements. This approach has a number of attractive features, namely

  • It is simple to ensure that all points are covered

  • It makes auditing simple

This approach has a number of downsides,

  • The resulting manual is unreadable, and will tend to be used only during audits
  • When the structure of the standard changes, the manual has to change. It is apparent that there are a number of points within the standard that have required clarification and it is expected that a revision will be produced in the not too distant future.

The former is by far the more serious problem, if a Quality system is to add value, it must be “live” and the manual should be the main reference for people in the company.
 

Our approach, the other extreme: The other extreme is to structure the Quality Manual (and thus the system itself) around the actual requirements of the company. Each company has its own unique approach to doing business that tends to be sculptured by the specific requirements of their marketplace. By developing a custom approach for the Quality Management System, it is possible to ensure that the benefits of formal approaches are gained whilst minimising the overhead associated with the system.

When a system based on this approach is implemented the people involved in the company are much more likely to feel at home with the system and accept it rapidly. Also the familiarity will enable improvements to be found much quicker. The disadvantages of this approach are,

  • The design of the quality system requires more effort to ensure that it matches both the company’s requirements and those of the standard.
  • Auditing will be less straightforward since the individual points are not so apparent.

The former is just a fact of life; you have to put effort in to gain the benefits... but it is worth it. The latter can be improved by providing a cross-reference document to ensure that you and the auditor can easily identify the relevant sections.

We can assist you to implement your quality management system in the most efficient and cost-effective manner, in addition, our experience and background in continuous improvement will ensure that your system will provide real benefits to your business.

Quality Aussurance
 

ISO 9001

The standards

Our Approach
 

ISO14001

ISO13485

 

 

Processes

ISO 9001 Overall process

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