The document outlines the ISO/IEC 17025:2017 standard, focusing on structural requirements in Clause 5 which emphasizes the importance of laboratory management roles, responsibilities, and ensuring valid results. It discusses the need for documented information to support laboratory processes and operations while addressing risks and compliance with legal obligations. The article highlights the necessity of proper training and procedures to meet accreditation standards effectively.

1. Introduction to ISO/IEC 17025:2017–Structural Requirements
ISO/IEC 17025:2017: Structural Requirements
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
Feel Free to Consult us for - ISO 17025
consultancy
Today as “We Go for ISO/IEC 17025”
we are going to look at the requirements
in Clause 5: Structural requirements.
The reason we are starting at “5” of
17025 standards 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 of
17025 has been discussed in our
previous newsletter, this is a
continuation series to provided details to
all our readers.
Clause 5: Structural requirements
This clause looks at your laboratory as a
legal entity where overall responsibilities
and activities are identified in order to
meet all requirements of 17025 standard
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. In today’s world
accreditation bodies are travelling
globally to assist and audit international
laboratories, auditors are required to
verify the registration document of the
company (either as lab or a part of the
big organization), they want to make
sure that your lab can be
held responsible and take appropriate
actions as needed to safeguard the
customer information.
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 per 17025.
“Lab’s capabilities are defined here as a
range of capabilities and can be part of
ISO17025 scope of accreditation”
You will need to ensure that you have
the ability to consistently operate
yourlab business while taking actions to
address risks and
opportunitiesandmeeting your legal
obligations.
Documented information will support
the operation of the processes
andprovide confidence that they are
carried out as planned.
Each laboratory processand activity are
looked at to make sure that it meets the
requirements of the 17025 standards.
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
we can improve our lab performance.
CAL LAB ACCESS, has developed a
procedure toaddressthis requirement
including job description, org chart,
roles and responsibilities to meet 17025
requirements.

2. Introduction to ISO/IEC 17025:2017–Structural Requirements
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Source:
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