ISO
9001 is the general standard which specifies the requirements for a quality
management system. Laboratories which meet the requirements of ISO 17025 also
operate in accordance with the requirements of ISO 9001 that are relevant to
calibration and testing activities.
What
this means in practice is that an organisation which holds ISO 9001 certification
may use a laboratory accredited against ISO 17025 as a supplier of test data
without the need to carry out its own audit of the laboratory’s quality system.
The question often arises of whether laboratories should be
accredited/certified to ISO 9001 or to ISO 17025. In general it is agreed that
the appropriate accreditation for commercial testing and calibration
laboratories is to ISO 17025. As a result of agreements with laboratory
accreditation bodies many ISO 9001 certification bodies will not allow their
certification to be cited by commercial testing or calibration laboratories in
support of their services. What this means in reality is that if you are an ISO
9001 certified organisation with an inhouse laboratory which forms part of your
quality control system, the laboratory will be included in the ISO 9001
external audit. However, if you then want to sell the services of that
laboratory to outsiders as a testing service you cannot advertise it as an ISO
9001 accredited/certified laboratory. You would need to obtain accreditation to
ISO 17025.
It
is not uncommon, however, for organisations with laboratories used purely for
internal quality control purposes to seek to accredit the laboratory to ISO
17025. This is generally done to enhance the laboratory’s, and hence the
overall quality control system’s, credibility or as part of the application of
an ISO 9001-compliant system.
ISO
9001 external auditors will not usually do a detailed audit of such an internal
laboratory if it holds a current ISO 17025 compliant accreditation. The quality
system in the laboratory is largely taken for granted for ISO 9001 purposes.
Since laboratory accreditation procedures leading to ISO 17025 accreditation
are explicitly designed for laboratories, they can be easier to interpret for
the laboratory as opposed to the rather more diffuse requirements of ISO 9001,
which are designed for a more general context. The other advantage of
accrediting an internal quality control laboratory is that it will generally
reduce the number of audits by customers and this is often a key reason for
Page 5 seeking accreditation. Frequent audits by a range of customers can be
disruptive to operations.
There
are certainly a number of significant omissions from ISO 9001 as compared to
ISO 17025 although, as already discussed, there is a general ISO move to bring
the standards closer together. The additional requirements in ISO 17025, as
opposed to ISO 9001, include participation in proficiency testing, adherence to
documented, validated, methodology and specification of technical competence,
especially on the part of senior laboratory personnel. There is also a
difference in the method of scrutiny of laboratories under ISO 9001 as compared
to ISO 17025 assessment.
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