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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.


Survival Guide:
Eight Hot Buttons Auditors Always Examine


1. Quality System. Particular attention is paid to the quality policy. It can't just be a piece of paper on the wall; your employees need to be able to state what it is and what it means to them. Don't make it so complicated they can't explain it to the auditor.

2. Management Review. Make sure that the agenda for management reviews is defined in the procedures, and conduct at least one review before your audit.

3. Document Control. Document control is scrutinized more than any other area, particularly whether the documents being used on the floor are the latest revision.

4. Purchasing. Implement a formal supplier assessment and monitoring procedure. Develop supplier histories and why you bought from that supplier.

5. Calibration. Dispose of all equipment requiring calibration that you no longer use. Don't take a chance on having anything out of calibration. Create a master maintenance schedule and calibrate everything to industry standards.

6. Internal Quality Audits. Put an internal audit program together and implement it. Cross-train staff to perform audits and hold at least one internal audit before your external auditor arrives.

7. Corrective Action. Ensure that corrective actions are conducted in a timely manner, documented, and signed off. It's a good idea to have them reviewed for trends and process improvements during quality meetings and management reviews.

8. Training. Ensure that all your training records are current, up-to-date, and easy to locate. Make sure that employees have completed necessary training, and that the trainers are qualified to teach.


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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