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!

 

 

 

 

And then there is Samsung

I was in on of the storefronts of my cellular carrier last weekend.  I was there to tie up some loose ends related to my upgrade to the Samsung Note 7.  A week into my new phone experience I was sold.  This phone is fantastic.   The associate who was working with me noted that there wasn’t a single unit in the entire region, and that the phone was on back order.  This surprised me.  I hadn’t heard of massive lines, or runs on stores of iPhone fame.

Continue reading And then there is Samsung

The Ideal QA Manager… Is Predictable

It is a well known fact that consistency is valuable.

For a QA Manager, consistency is imperative.   It is hard to imagine a QA Manager that is effective and inconsistent.

I have to believe that this opinion, which has been expressed on numerous occasions, is the result of a QA Manager whose approach (real or perceived) is misaligned with the needs (or wants) of those in Operations.

Let’s face it, QA Managers are in a precarious position.  They are the overseers, the enforcers.  The have hard lines to tow.  They are ultimately responsible for the accountability in the entire facility.  It’s a heavy burden…  A thankless burden, as I’ve mentioned before .

Continue reading The Ideal QA Manager… Is Predictable