Laboratory Accreditation: Making Conformance Count
- What is Accreditation?
- Who makes it work?
- How is it controlled?
- Why do it?
- Where do I get more information?
What is laboratory accreditation?
The international standard for competence in
laboratories is ISO 17025.
Accreditation to this standard allows for mutual recognition of data generated
by laboratories worldwide. For such a holistic approach to work, all
laboratories must operate within the same set of guidelines.
ISO 17025 is written in such a way as to allow this to happen without undue
proscription on business practice within the organizations to which the
individual laboratories belong. It is, in essence, an over-arching statement of
intent implemented by documented processes through validated methodology
supported by record-keeping and audit.
This process driven approach is a move away from previous compliance based
Who makes it work?
It is the responsibility of each laboratory
to write and implement a quality system according to the principles detailed in
To avoid divergence as a result of over flexibility in the inter-laboratory
interpretation of the standard, external inspections are required. These
inspections take the form an initial assessment and award, followed by
surveillance assessments to monitor on-going conformance and the cycle is
closed by a further certification assessment on a rotating basis.
The assessments are rigorous documentation reviews coupled to witnessed reviews
of work taking place but can only be a snap-shot of the entire laboratory
operation at the time of the visit. It is essential therefore that there is a
commitment at the highest level within the applicant organization to adhere to
the spirit of the standard at all other times.
The recommendation for award of accreditation to the standard will require the
satisfactory resolution of any non-conformances raised at any and all of the
visits. The scope and timescale of resolution will be discussed, recorded and
agreed at the time of the assessment visits.
How is it controlled?
The standard ISO 17025 is controlled by the
International Organization for Standards (ISO).
At a national level, awards of accreditation to this standard are controlled by
various certification bodies, e.g. L.A.B and NVLAP in the USA, in Europe, UKAS
Certification bodies are empowered by national accreditation bodies, usually
government agencies, (who may also be certification bodies). Mutual recognition
agreements exist to allow for international co-operation.
In the USA, NACLA assess and recognizes certification bodies. In the UK, UKAS
performs the same task. Most national accreditation bodies are signatories to
the ILAC (International Laboratory Accreditation Co-operation). Which leads us
neatly back to ISO.
Why do it?
Valid analytical measurement is the goal of
all laboratories large or small.
The competent operation and confident reporting indicated by accreditation to
ISO 17025 allows client relationships to flourish without doubt and uncertainty
to muddy the waters.
The standard almost demands communication both within the laboratory and
outside of it. The resultant clarity facilitates operations and, properly
harnessed, will improve the development of the laboratory as a business with
the concomitant budgetary advantages.
At the beginning of the last century, the UK government linked the value of the
Sterling currency to the price of gold. The so called 'gold-standard' was
eventually adopted by all the major currencies around the world. With the
eventual inclusion of the US dollar, this precipitated previously unimagined
economic growth through stable international trade.
ISO 17025 allows the mutual recognition of data between accredited laboratories
worldwide. The certificates of analysis generated by these laboratories and the
goods they support will facilitate international trade. As the world wakes up
to emerging economies ISO 17025 is the system that will allow the world to
sleep easier at night.
Where do I get more information?