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What Makes a Quality Manual Good Enough for ISO 17025 Accreditation?

03/01/15

When a lab applies for ISO 17025 accreditation, one of the most important documents they submit is the official quality manual. This is the document that outlines all quality control practices and supporting procedures in one place. Creating this manual is a big job but, if done right, it will make your accreditation process easy. So what makes a quality manual good enough for ISO 17025 accreditation? Here are four of the mainstays:

  1. Make sure your practices are in order. A common problem that we see with labs preparing for their first ISO 17025 accreditation process is that they become too focused on the accreditation itself rather than on the internal practices that the accreditation is based on. This can lead to the creation of a quality manual that looks much better than your practices themselves—but any ISO 17025 accreditation auditor is going to notice the discrepancies quickly. Thus, the best way to approach creating your quality manual is as a chance to review and improve internal processes. Expect that, as you advance through outlining, drafting, and finalizing the manual, you'll uncover weak spots in your current quality assurance procedures and need to take steps to address them. In this way, your quality manual becomes much more than an item on a checklist – it becomes a guiding force for improvement within your organization, which is exactly what it's meant to be.
  1. Use the right format. There is no single quality manual format that is strictly required by ISO 17025 standards, but most more or less follow a standard format that divides all procedures into neat categories and explains each one in a straightforward way. You may add sections based on your specific industry but, for the most part, following a standard format will help make your quality manual not only easier to review, but also thorough (which is the name of the game). See if you can get ahold of sample quality manuals from other accredited organizations and model your own manual on their format.
  1. Gather input from staff experienced with ISO 17025. As with everything in lab work, experience, transparency and peer discussion only improves the end product. While you can task a single staff member with assembling all the documentation and writing the manual, the result will be better if they have input from staff members who are experienced with ISO 17025 standards. If necessary, consider bringing in an outside consultant with ISO 17025 experience to review your materials as you draft them.
  1. Double check all documentation. Just because a procedure is in the manual—or perhaps even used on the floor—does not mean that it's reflected in all of your policies and protocols. Once you have a complete quality manual, pull together all supporting documentation and make sure the actual procedures match the quality manual's claims.

Are you seeking ISO 17025 status? How are you creating your quality manual?