An ISO/IEC 17025 audit is likely not something anyone looks forward to. It disrupts the normal workflow of the lab and everyone feels as though they’re under a microscope. Whether it’s your first time or you’re a veteran, an assessment can make anyone feel a bit nervous. Luckily, you can draw on the experiences of others to help navigate you through to a successful accreditation. Here are some tips from labs with assessment experience.
The most important advice for preparing for an assessment is to have organized documentation. Without having your documentation organized, it’s difficult, time consuming, and sometimes impossible to respond to questions from the auditors. The quicker and easier you can answer questions, the happier your auditors will be and the more professional your lab will seem. What will the auditor’s questions be? Thankfully, it’s not a secret. It may be obvious, but the ISO/IEC 17025 document is the perfect guidebook for what the auditors will be looking for and asking. There are two general methods of organizing your documentation.
- Method 1 – One method is to have a spreadsheet or other document to act as a cross-reference between your documentation and the requirements in the ISO 17025 document. For each ISO 17025 requirement, your cross-reference specifies exactly where in your documentation the requirement is satisfied and includes notes about examples, if applicable. This method works, but it usually requires a lot of jumping around between different documents and in practice, the cross-reference is seldom version controlled and tends to become out of date.
- Method 2 – A better method to organize your documentation is for your top level document to exactly mirror the ISO 17025 document. For example, the requirement in section 4.2.3 of ISO 17025 matches to section 4.2.3 of your Quality Manual, which defines how your lab satisfies the requirement. Having your documentation organized like this makes assessments very straight forward. This makes assessments easier for you and the auditors.
Every auditor and assessment can be a bit different, but it’s prudent to prepare and review the often-asked-for documentation beforehand. Auditors will have their own preferences, but generally, it’s convenient to have access to documentation in both electronic and paper form. Paper copies can be easier to look over together during an assessment, but electronic copies are easier to store and review later. The following documents will certainly be requested during an assessment.
- Quality Manual (4.2.2)
- Master List of Documents (188.8.131.52)
- Approved Subcontractors List (4.5.4)
- Approved Suppliers List (4.6.4)
In addition to the documents above, you should also expect to provide example records. Before the assessment, it’s very important that you pick “perfect” example records that you have thoroughly reviewed to be accurate and conforming to ISO 17025 requirements and the requirements of your own documentation. Such example records would include the following.
- In-House Test Reports (5.10)
- Subcontracted Test Reports (5.10)
- Calibration Records (5.10)
- Corrective Actions (4.11)
- Preventative Actions (4.12)
- Management Reviews (4.15)
- Feedback (4.7.2)
- Complaints (4.8)
- Training Records for all Lab Personnel (5.2)
- Proficiency Testing Results (5.9.1)
It’s important to have these records ready when the auditor asks for them, but it’s a good practice to only give the auditor the documents he/she has asked for. Giving more documents only increases the chances of an auditor finding something wrong.
So much of the preparation effort is spent on documentation and the management system, it can be easy to forget that that a large part of the assessment is performing tests. It’s important to prepare lab technicians for spending a lot of time performing and explaining tests to auditors during the assessment. It can also be helpful to have test samples on hand for the technicians to use for test demonstrations. For short tests that can be completed in a single day, auditors will likely request to witness the test from start to finish. For longer multi-day tests, auditors will probably only want to witness different stages of the test process with the lab technician explaining the stages the auditor was unable to witness. During all of the test witnessing, the auditor will ask for calibration records for every single piece of calibrated equipment the technician uses, so be sure to have those records reviewed before the technician uses them.
During the Audit
You will likely encounter issues during the audit that could become a deficiency that the auditor may or may not notice. If an auditor doesn’t notice, do not try and hide it from the auditor. On the same note, you also do not need to bring attention to it. Make sure you note it, and fix it later. Answer any questions from the auditor clearly, but also concisely. A simple “yes” or “no” is sufficient. Do not argue with the auditor, but also do not be afraid to challenge him/her if there’s good reason to believe the auditor is wrong about a deficiency. Politely state your case, and move on if the auditor does not change his/her position.
Being well-prepared with thoroughly reviewed and organized documentation is the best step you can take for an upcoming audit. It not only saves you time and money during the assessment, it makes your auditors happy and gives them less time to find a deficiency. Your auditors want you to do well, so you’ll do your lab a favor if you make the assessment easy for your auditors. Remember, while your lab’s goal of the audit may be zero deficiencies, it’s important to remember that the audit is an opportunity to improve your quality system. Note, you may be able to use your auditor as a consultant in the future. If you liked and thought your auditor was helpful during the assessment, he/she could be a great resource for the future so it’s important to maintain that relationship.