Effective Audit Tips on ISO 17025 Accreditation
Written by Damon Anderson
Are you ready to face the final audit for gaining ISO 17025 certification? Then you must have a look at certain audit tips to ensure the certification. Go through this article to explore some effective audit tips on ISO 17025 standard.
ISO 17025standard requires an audit that may disrupt the regular workflow of a calibration lab. Everyone thinks that he/she is under a microscope whenever the audit is going on. No matter whether you are going through an audit for the first time or you have been going through the similar experiences over the years, audit always makes people a bit nervous. However, you can make your audit easier by drawing on the experiences of others. This way, you will be able to navigate through a successful accreditation process. In this article, we are going to share some effective tips on ISO 17025 accreditation with you.
Organized Documentation
Whenever you are preparing for the audit, it is important to organize your documentation. Disorganized documentation would make the process lengthy and time-consuming. Above all, you would find it difficult to respond to the questions asked by the auditors. Always remember that quicker you can answer, happier will be the auditors.
Moreover, it will highlight the professionalism of your laboratory. There are two methods that you can follow to organize your documents, such as-
You can have a spreadsheet or other document to act as a cross-reference between the documentation and the ISO 17025 requirements. For each of the requirements of ISO 17025 standard, your cross-references should point out exactly where the documentation the requirements are getting certified and including example notes. However, this method requires a lot of efforts around different documents and practices.
The second method is comparatively easier than the previous one. Through this method, you can organize your documents in the right order. For instance, a requirement stated in the 4.2.3 section of ISO 17025 matches to the section 4.2.3 of the quality manual of an organization that explains how the organization meets the requirements. This way, you can make your projects easy to understand and brief. Auditors always prefer documentation that explains all the vital aspects within a short span of time. This preference is similar in all other popular standards such as R2 Responsible Recycling Standard.
Vital Documents
It is obvious that every auditor has a different approach and every assessment is unique. However, preparing and reviewing the frequently asked questions for the documentation would be a discrete decision. Let the auditors have their own preferences. Still, it would be convenient to get access to the documentation in both electronic and paper format. It may seem that paper copies are easier, but it is not. The electronic copies have more than one benefit. It can be easily stored to review later. Therefore, it would be better to prepare electronic copies of the vital documents. Now, let’s have a look at some vital documents, which are included in the guideline of ISO 17025 accreditation.
- Quality Manual (4.2.1)
- List of all the Documents (4.3.2.1)
- List of Approved Subcontractors (4.5.4)
- List of Approved Suppliers (4.6.4)
Apart from these, you can be asked to come up with example records. In such a case, it is important for you to pick the suitable examples that you have assessed several times before the assessment. You can consider the following records:
- In-House Test Reports (5.10)
- Subcontracted Test Reports (5.10)
- Calibration Test Reports (5.10)
- Corrective and Preventive Actions (4.12)
- Management Review (4.15)
- Feedback (4.7.2)
- Complaints
- Training Records
You must keep these records ready; who knows when the auditors may ask you to provide them! Give the auditors only the documents they have asked. Giving more documents, which are not that essential at all, can confuse the auditors. Moreover, it increases the chances of the auditors discovering gaps or flaws in your documents.
Test Demonstration
This documentation is of immense importance in the context of ISO 17025 standard. You must document how you are performing the test. Demonstration of the tests can help the auditors determine whether you are opting for the right methods or not. Sometimes, the auditors ask the laboratories to conduct a test before them. Therefore, you should keep your staffs and technicians prepare.
A Final Takeaway
If you want to ensure your certification, you must be well prepared with organized documentation. It will save your time and money while, at the same time, it will make the suppliers happy with your arrangements.
Article author
About the Author
Damon Anderson is a renowned market guru and ISO experts having some useful blogs on ISO 17025 accreditation, ISO 13485 Standard, R2 Responsible Recycling, etc. You can follow his blogs to gain insight into the ISO standards and market trends.
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