ISO/IEC 17025:2017 Requirements
The requirements of the
ISO/IEC 17025:2017standardsare organized in five sections or “Clauses”
Section 4: General requirements
Section 5: Structural requirements
Section 6: Resource
requirements
Section 7: Process requirements
Section 8: Management system
requirements
Today as “We Go
for ISO/IEC 17025” we are going to look at the requirements in
Feel Free to Consult - ISO 17025 consultant , Cal
Lab Access is leading services provider for
Clause 4: General requirements and Clause 5: Structural
requirements.
The reason we are
startingwith Clause # 4 is because the first three clauses do not have actual
requirements; they are more of an introduction to the standard. The
requirements are outlined in clause 4 through clause 8.
Clause 4: General Requirements
This first clause introduces
two sub-clauses as general requirements.
First is impartiality, where
laboratory activities are undertaken and managed in a structured manner in
order to safeguard impartiality and provide presence of objectivity.
Second is confidentiality,
where the responsible management of information obtained or created during the
operations of a laboratory is considered and treated as confidential.
CLA have developed a very
strong and audit ready document that covers all the requirements of this clause
with risk identification and level of risk associated with each laboratory
activity.
Clause 5: Structural requirements
This clause looks at our
laboratory as a legal entity where overall responsibilities
and activities are
identified in order to meet all requirements and ensure valid and accurate
results. This section also asks the laboratory management to ensure that the
organizational roles, responsibilities, and authorities for relevant functions
are assigned, communicated, and understood.
The
range of our laboratory activities will determine the scope of the LQMS, and
includes the various services associated with laboratory tests, calibrations,
and sampling.
“Very important aspect of this clause is defining your Scope of
Accreditation”
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You
will need to ensure that you have the ability to consistently operate yourlab
business while taking actions to address risks and opportunitiesandmeeting
legal obligations.
Documented
information will support the operation of the processes andprovide confidence
that they are carried out as planned.
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Each laboratory processand
activity are looked at to make sure that it meets the requirements of the
standard. Relevant documented information is provided to make sure that the
process is well planned and that everyone does the process in the same and
correct way.
Procedures are used to train employees on using the
approved methods,so that youcan improve lab performance.
Our procedure on Impartiality
and Management Responsibilityaddresses
both clause 4 and clause 5.
Our documents and procedures
have been through many audits by A2LA, PJLA, ANAB, etc., with no findings. We
look forward to assisting you with your ISO/IEC 17025 project.
