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0 ISO 17025 2017 Trans
0 ISO 17025 2017 Trans
0 ISO 17025 2017 Trans
If you are thinking of preparing an ISO 17025 2017 version Laboratory Management System (LMS) then where do you start?
We start with a Gap Analysis to determine the gap between your current management system and an ISO 17025 conforming
LMS. A Gap Analysis is used to assess an organizations scope, readiness, and its resources for building the system. It also
provides us with the data to develop a project plan for ISO implementation.
This gap analysis checklist can be used in evaluating your Laboratory Management System (LMS) against the requirements of
ISO 17025:2017 as you transition from ISO 17025:2005 to ISO 17025:2017.
New requirements and / or new terminology are highlighted in bold red.
An explication of the main clauses of the new standard is shown in bold blue font.
The second column is intended to provide reference / comparison to the ISO 17025:2005 requirements.
Comments in the second column highlighted in bold red font indicate removed / missing requirements.
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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This shall include those risks that
arise from its activities, or from its
relationships, or from the
relationships of its personnel.
However, such relationships do not
necessarily present a laboratory
with a risk to impartiality.
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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of all information obtained or
created during the performance of
laboratory activities.
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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The provider (source) of this
information shall be confidential to
the laboratory and shall not be
shared with the customer, unless
agreed by the source
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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5.2 The laboratory shall identify
management that has overall
responsibility for the laboratory.
4.2.2 The quality policy statement issued under the authority of top
management includes at least the following:
a) The laboratory management’s commitment to good professional practice and
to the quality of its testing and calibration in servicing its customers.
b) The management’s statement of the laboratory’s standard of service.
c) The purpose of the management system related to quality.
d) Requirements that all personnel concerned with testing and calibration
activities within the laboratory familiarize themselves with the quality
documentation and implement the policies and procedures in their work.
e) The laboratory management’s commitment to comply with ISO/IEC 17025
and to continually improve the effectiveness of the management system.
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INSERT COMPANY NAME/LOGO HERE
ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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4.2.5 The roles and responsibilities of technical management and the quality
manager, including their responsibility for ensuring compliance with ISO/IEC
17025 are defined in the quality manual (however named).
5.3 The laboratory shall define and 4.2.1 Establish, implement, and
document the range of laboratory maintain a management system
activities for which it conforms to appropriate to the scope of the
ISO/IEC 17025? lab activities.
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INSERT COMPANY NAME/LOGO HERE
ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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5.5 The laboratory shall: ----
5.6 Does your laboratory have 4.1.5 a) The laboratory has the
personnel who, regardless of other managers and technical
responsibilities, have the authority personnel who, irrespective of
and resources needed to carry out
their duties? other responsibilities, have the
authority and resources needed
to carry out their duties.
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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Implementation, maintenance, 4.1.5 a) Implement, maintain,
and improvement of the and improve the system.
management system?
Reporting to laboratory
management on the performance
of the management system and
any need for improvement?
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ISO/IEC 17025:2017 Laboratory Management System -
From the ISO 17025:2005 to ISO 17025:2017 Transition Checklist
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4.1.6 Management
communicates the effectiveness
of the system.
4.2.3 Management
communicates importance of
meeting customer requirements
along with statutory and
regulatory requirements.
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