ISO/IEC 17025:2005 Implementation

(Requirements for laboratories move forward with changes)

It has now been a number of years since the laboratory community has seen change in the
standards for accreditation. For many years, ISO Guide 25 was the primary guidance
document under which laboratory accreditation bodies granted accreditation to testing
and calibration laboratories.

At the turn of the century, the laboratory community began seeing the first change by
having to transition to the new Standard, ISO/IEC 17025:1999.

This caused the laboratory community to see many and substantial changes to the
requirements for accreditation. Moving from a Guide Document to a Standard meant
conformity to requirements put forth as “shall” rather than “Should”. This meant that all
laboratories meeting this standard would have to conform to this requirement and not just
do so as they see it as a good laboratory practice.

ISO/IEC 17025:1999 also became a “stand alone” standard, by incorporating the relevant
requirements of ISO 9000: 1994 as Section 4 of the standard. Section 5 contained the
technical requirements, which make the standard very different and more far reaching
than Registration to ISO 9000 alone.

During that same time, ISO/IEC, modified ISO 9000:1994. While the modifications are
not considered significant, it did mean that ISO/IEC 17025:1999 had to be revised to
make proper use of the new terminology contained in ISO 9000:2000. ISO/IEC then
began the process of bringing the ISO/IEC 17025:1999 standard in line with the new ISO
9000:2000.

The International Laboratory Accreditation Cooperation (ILAC) has confirmed that there
will be a transition period of two years for full implementation. L-A-B is in the process of
completing the guidance documents along with appropriate check lists for use by
accredited laboratories and assessors.

Since L-A-B’s accreditation program involves a yearly visit, L-A-B intends to use these
visits to assess the laboratory’s conformance. This will help to avoid extra work on the
part of L-A-B and the accredited laboratories and of course the costs associated with the
effort..
 Important Events

On May 15, 2005, ISO/IEC release the latest version of ISO/IEC 17025:2005

ILAC confirms a transition period of two years for full implementation of ISO/IEC
17025:2005.

Effective October 1, 2005, L-A-B will, at the normally scheduled visit, assess the
laboratory to ISO/IEC 17025:1999 and do a gap analysis to the requirements of ISO/IEC
17025:2005

If the result is that the laboratory conforms to the requirements of ISO/IEC

17025:2005, then the accreditation will be granted to the new standard.

If the result is that the laboratory conforms to ISO/IEC 17025:1999, but not
ISO/IEC 17025:2005, the laboratory will be accredited to ISO/IEC 17025:1999
and corrective actions established and accepted in response to the gap analysis
non-conformances before the laboratory can be accredited to ISO/IEC
17025:2005.

On October 1, 2006, all laboratories being visited will be assessed to ISO/IEC

17025:2005 only. The laboratories will follow the normal corrective action
process required by L-A-B.

All laboratories in process, but not accredited yet, will have the assessment done to
ISO/IEC 17025:2005 effective October 1, 2006. They will follow the normal corrective
action process to resolve all non-conformances before the accreditation may be granted.

Accredited laboratories who do not wish to wait until their next regularly scheduled visit
to be assessed to the new version of the standard, may request that L-A-B do the
document review necessary to determine that the laboratory is operating in accordance
with the new ISO/IEC 17025. This will involve an interim project for the client and will
be done at a document review charge of $400.

Contact L-A-B if you have any questions

L-A-B Operations Office L-A-B Sales and Customer Service

Tel: (260) 493 0822 Tel: (260) 413 5228
E-mail [lmumma@l-a-b.com] E-mail [rlevine@l-a-b.com]