If your lab is ISO/IEC 17025 accredited, you need to know the ins and outs of the standard. One area to pay special attention to is nonconformances. We’ve partnered with the American Association for Laboratory Accreditation (A2LA) to provide a series of webinars on this topic.
In the third episode, we had the opportunity to learn from Ms. Bibi Abdullah. Abdullah is an Accreditation Specialist at A2LA. She supports the day-to-day operations of accreditation by assisting clients in obtaining and maintaining accreditation in the field of Materials Testing and Inspection Bodies. In addition, she is A2LA’s point of contact for CPSC, as well as the deputy of A2LA’s Forensics Program.
In case you didn’t know, the majority of nonconformances are related to section 6.6 of the standard. In fact, 21% of all deficiencies are from section 6.6, specifically 6.6.2. That’s why in this episode, Bibi highlighted the top 5 clauses that receive nonconformances and gave us examples of how laboratories can address and prevent them.
Though this may seem out of order, 6.6.2 B comes first because it’s the top nonconformance that A2LA sees.
Shockingly, section B makes up almost 20% of all deficiencies within section 6.6.2!
This section requires you to have a record and procedure for evaluating, selecting, monitoring performance, and re-evaluation of your external providers.
Here are two great tips for record keeping:
Pay attention here because this is a completely new requirement. You now need to have a procedure and record for defining, reviewing and approving the products and services received.
Section 6.6.2 A accounts for 11% of deficiencies cited in 6.6.
In order to create a passing procedure, you need to define the requirements for the products/services you will obtain externally.
When it comes to the records, you need to be sure to document the approval criteria.
Once you have defined your criteria, selected your external provider and requested the products and services, you need to ensure that the products or services meet the requirements (see 6.6.2 A) BEFORE use.
Bibi suggests that your procedure addresses how products and services will be checked upon completion.
In terms of records, you need to show you have approved the products or services you’re receiving. This approval can be as simple as a signature or stamp.
So what happens if you approve a piece of equipment and it doesn’t work as expected? In this case, it’s recommended to include a record that shows you’ve checked the piece of equipment against the criteria set forth in 6.6.2 A.
Another completely new requirement – this section is asking you to have a procedure and record for addressing actions related to evaluations, monitoring of performance, and re-evaluation of external providers.
The best tip for streamlining this procedure is to explicitly address how your lab will act should issues arise during evaluation.
One big item is to document the criticality of external services and supplies to your results.
Another is to communicate your acceptance criteria in regards to your external providers. The standard doesn’t define which type of communication method you should use, so a phone call, email or purchase order are all acceptable forms.
We also recommend innovating with a QMS like Qualtrax to help you stay in compliance. We have lots of customers that are ISO/IEC 17025 certified and use our product to manage their accreditation.
One way our product addresses the complexity of 6.6.2, specifically, is through workflows. We even have a vendor approval workflow already designed and ready for use for all of our customers. This workflow allows you to capture information about your vendors, create lists, collect evaluation information and achieve final approval. You can even set reminders to re-evaluate your vendors at intervals that work for you. By using Qualtrax workflows, you’re conforming to the process you’ve put in place and will have the data to back it up.
If you’re not familiar with Qualtrax, you can set up a call with one of our representatives to address the specific needs of your team and identify the ways that Qualtrax can keep you on the path to compliance! You can even get a free trial!
Externally Provided Products and Services Requirements can be a complicated aspect of accreditation to manage. This blog was only a summary of the rich information that Ms. Bibi Abdullah shared with us in this episode. Not only are there more tips to learn, but our attendees asked great questions that we’ve answered at the end of the episode. You don’t want to miss it!