Category Archives: Annual Review 2014

Accreditation and Interpretations

assumptionWhether you are the quality manager of an accredited laboratory, or preparing your laboratory for accreditation, understanding the standard you will be accredited to can be daunting.

If you’re new to the game, accreditation requires that an independent “Accreditation Body” perform an audit (or assessment) of your laboratory to ensure that you meet the requirements of the standard that you are referencing.

Now, the challenge comes when the assessor’s interpretation of the standard requirements differ from the laboratory’s interpretation.  Prevention is the key to audit findings associated with differences in interpretation.  I was reminded of this recently during the annual meeting for our accreditation body.  I thought I’d share some of the tools I use to ensure that our interpretation of the standard aligns with assessors that come in to audit us.

1.  FAQs and Interpretations

Governing and accreditation bodies have gotten wise to the challenges facing laboratories in understanding what is expected of laboratory’s to meet requirements that can be vague. Most have provided interpretations to clauses that have been problematic.  This isn’t a new concept, but not often one used by laboratories.  Two of note:

These cover primarily the environmental and food testing industries, which have requirements that are additional to those in the ISO 17025:2005 standard.  Each accreditation body has a similar resource with interpretations as well.

2.  Training

If you are new to the quality role, or pursuing accreditation, a great way to understand how your accreditation body interprets the standard is to attend a training session, facilitated by the accreditation body, about the standard.

3.  Get Engaged

Most accreditation bodies, as well as some governing bodies, will have an annual meeting of their stakeholders.  These meetings are where policy for the accreditation body is set and standard interpretations are clarified.  I’ve made a point to be involved in these types of meetings from very early in my career.  It’s not only a great networking event, but there is added value to knowing what current issues are brewing within the industry.  These hot topics are always a point during subsequent audits, so its good to know about them in advance.

A note about these meetings.  I find that laboratories are almost always grossly under-represented.  This is unfortunate.  I mentioned that these meetings are where policy for the Accreditation Body is established, revised, and approved, by the stakeholders.  By not attending these meetings, laboratories are missing out on the opportunity to have their voice heard within the accreditation community!  That is why I’m such a big proponent of getting to those meetings.

If you have any questions about how to find additional resources for standard interpretations, please drop a comment below!





How to move a Lab and not go CRAZY!

the getaway2014 has been an interesting year in the life of this QA Manager. This time last year, we were in a full court pressto prepare the lab to move into our new facility. As we ushered in the year, the facial twitch caused by transferring equipment, personnel, and systems was deeply present. Of course, moving a lab is not a new concept. It was, in no small scale, a big deal for our team.

I was reminded of that this week while searching for an email that I sent at the beginning of the year. Plenty of labs have relocated, mostly successfully.   But that doesn’t negate the fact that the project was extremely challenging. Specifically, the instrumentation that we employ could not simply be loaded onto the back of a pick-up truck. It took no less than a full day to prepare each instrument to move, another day to crate, forklift, and haul each instrument to the new lab, followed by two days of installation. The coordination involved in moving all four of our instruments could be a full discussion of choreography and agility. 

As I scrolled through my email traffic early 2014, one thing was apparent. As a team, we were on fire.

When we entered into the project, we had a strategy.   We had a schedule. We had a punch list. Most importantly, we made a commitment to stay agile. We new from the start that through all of the planning, the schedules, the punch lists, there would be surprises. There would be crises. How we reacted would be the key to our success or failure.

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