Useful Tips for an ISO 17025 Accreditation Audit

Published: 17th October 2011
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An ISO quality management or environmental management system audit can be stressful and troublesome task for many people in companies today. In this article, we have shared some useful tips for a successful audit. These are based on the real world experiences consulting with more than 100 companies audits over the past two decades. These tips apply to ISO 9001; ISO 13485; ISO 17025; ISO 14001; RC 14001; AS 9100, BRC food safety or TS 16949 audits.

People at all levels in an organisation get anxious about an ISO registration or audit by their registrar. ISO 17025 is a highly technical standard and it helps in establishing competency and reliability. The experience and skill of people who perform the test is very much important for ISO 17025 accreditation. It requires to make ISO 17025 documents including Quality manual, ISO 17025 procedures, test methods, forms and instrument operating procedures. Proper preparation can help reduce the anxiety level. These tips will help you and everyone in your organisation to be well prepared for the audit.

1. Know your quality policy and how it applies to your job.
2. Know where to find the appropriate procedures, forms and documents required for ISO standards; it is fine to refer to them to answer questions but do not guess. Be sure all forms and records are up to date and completed properly.
3. Answer questions clearly, honestly and concisely. Do not keep on talking after you answer the question. Talk precisely and be aware that whatever you tell the auditor may have to be supported by the appropriate documents or records.
4. Know what to do with any non-conforming material (if it applies to your job).
5. Do not argue with the auditor. Questions asked by the auditor are fine, but don't argue.
6. Know your job, roles and responsibilities.
7. Be sure that your work area is clean and clutter free; have files, records and information readily accessible.
8. If you don't understand a question, ask the auditor to clarify or repeat the question. If a question is still not clear then ask someone to help you understand it. It could be a question that must be for someone else, if so tell the auditor it is not a part of your job and ask him/her to ask else. Do not guess at an answer.
9. Know what is done with a customer complaint (if it applies to your job).
10. If there are regulatory or special requirements for your job, process or product know and be able to explain them (i.e. FDA, FAA, special handling requirements; soldering; sterilization).
11. Know the quality objective and/or goals that apply to you.
12. If there are areas of which you are unsure, do not guess but refer to someone else.
13. Understand testing /calibration procedures for your laboratory and perform it as per defined test methods.
14. Remember, this is not an adversarial situation. Your company is paying the auditor to be there to do his/her job and the auditor is actually a customer. The auditor cannot fine you, send you to jail or get you fired. The auditor is there simply to assure that the QMS meets the requirements of the standard.
15. The auditor will not tell you how to do something, but may say something like "I have seen....., listen and learnt".
16. Be positive. Talk about successes as appropriate...just be aware that anything said could require documented evidence.

Thus, it is necessary to take care of all the above mentioned things. This will ensure a successful ISO 17025 laboratory accreditation standard audit and get an ISO 17025 certificate for your laboratory.

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