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APPLICATION ARTICLE

The following application article is part of a larger set of articles published under the title ISO 9000 in Scientific Computing as a special supplement to Scientific Computing & Automation magazine.


Implementation:
The Nine Steps to Registration


If you're wondering how seven short pages can be so difficult to understand, you're not alone. The best approach to take is to approach each milestone pragmatically, step by step. As with any major project, don't rush the process, but take the time to define your needs and ensure completion at each stage.

Remember that ISO 9000 focuses on documentation. As a result, addressing the standard does not need to be a complicated process. As long as you document what you do, do what you document, and write down what you've done, you can be certified and registered.

Essentially there are nine steps to implementing ISO 9000.

1. Establish an ISO steering committee, assigning a project leader.

2. Review your current quality system, assessing what procedures are written and what need to
be written.

3. Develop timelines and goals for each department.

4. Start documenting. Develop a standard format, revise existing procedures, create new
ones. Create the top level quality manual.

5. Select a registrar.

6. Assign and train internal auditors. Conduct at least one internal audit to test your procedures.

7. Submit your manual for a desk audit to the registrar.

8. Undergo an audit by the registrar.

9. Receive your ISO 9000 certificate and registration.

Selecting a registrar can take place as soon as you decide to pursue certification; it is certainly not necessary to wait until you've started documenting your processes. You can also bring a consultant in at any time during the process, depending on what type of consultant you wish to use and what you need the consultant to do.

The most time consuming portions of implementation are the document creation, of course, but also determining what needs to be done and who is going to do it. Most companies spend many hours discussing how the program should be conducted. Depending on your corporate culture, a fast "let's just do it" attitude can be as effective as a "let's think this through first" approach. Generally the process takes about 18 months. It can be expedited with the help of outside contractors who can assist with the writing and provide direction and advice. Hewlett Packard has implemented some systems in a mere six months. The time involved depends on the size of the organization and the scope of the registration.


The above article was written by Helen Gillespie, Web Master for the LIMSource, and reprinted from
Scientific Computing & Automation, February 1994


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