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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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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 170025:2017 ISO/IEC 17025:2005 Currently in Compliant If No - % Document

Requirements for the Reference Requirements Place YES / NO? Completed Needed
---
Competence of Testing and
Calibration Laboratories

4 GENERAL REQUIREMENTS 4 Management requirements

4.1 Impartiality ----

4.1.1 Laboratory activities shall be 4.1.4 Note 2. A third-party

undertaken impartially and laboratory demonstrates that it
structured and managed so as to is impartial.
safeguard impartiality

4.1.2 The laboratory management shall 4.1.5 d) Laboratory policies to

be committed to impartiality avoid activities that diminish
confidence in its impartiality.

4.1.3 The laboratory shall be responsible 4.1.5 b) Ensure that the

for the impartiality of its laboratory
activities and shall not allow
commercial, financial or other
pressures to compromise
impartiality.
management and personnel are
free from any undue pressures
and influences that may
adversely affect the quality of
their work.

4.1.4 The laboratory shall identify risks

to its impartiality on an on-going
basis.

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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.

With reference to the note in 4.1.4: ----

A relationship that threatens the 4.1.4 If the laboratory is part of

impartiality of the laboratory can a company performing other
be based on ownership, than lab services, the
governance, management, responsibilities of key
personnel, shared resources, personnel are defined to
finances, contracts, marketing identify any conflicts of interest.
(including branding), and payment
of a sales commission or other
inducement for the referral of new
customers, etc.

4.1.5 If a risk to impartiality is identified,

the laboratory shall be able to
demonstrate how it eliminates or
minimizes such risk.

4.2 Confidentiality ----

4.2.1 The laboratory shall be responsible,

through legally enforceable
commitments, for the management
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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.

The laboratory shall inform the

customer in advance, of the
information it intends to place in
the public domain

Except for information that the 4.7.1 The laboratory cooperates

customer makes publicly available,
or when agreed between the
laboratory and the customer (e.g.
for the purpose of responding to
complaints)
with customers providing that
confidentiality is assured to other
customers.

4.2.2 When the laboratory is required by

law or authorized by contractual
arrangements to release
confidential information, the
customer or individual concerned
shall, unless prohibited by law, be
notified of the information
provided.

4.2.3 Information about the customer

obtained from sources other than
the customer (e.g. complainant,
regulators) shall be confidential
between the customer and the
laboratory
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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

4.2.4 Personnel, including any 4.1.5 c) Policies to protect

committee members, contractors,
personnel of external bodies, or
individuals acting on the
laboratory’s behalf, shall keep
confidential all information
obtained or created during the
performance of laboratory
activities
confidential customer
information and proprietary
rights, including protecting the
electronic storage and
transmission of results

5 STRUCTURAL REQUIREMENTS 4.1 Organization

---- 4.2 Management system

5.1 The laboratory shall be a legal entity, 4.1.1 The laboratory is an

or a defined part of a legal entity, that entity that is legally
is legally responsible for its laboratory responsible.
activities.

With reference to the note in 5.1: ----

For the purposes of this document,

a governmental laboratory is
deemed to be a legal entity on the
basis of its governmental status.

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5.2 The laboratory shall identify
management that has overall
responsibility for the laboratory.

4.1.5 i) Appoint a member of staff as quality manager who, regardless of other

duties, has defined responsibility and authority for ensuring that the system
related to quality is implemented and followed. The quality manager has direct
access to top management where decisions are made on lab policy or resources.

4.1.5 j) Appoint deputies for key managerial personnel.

4.2.2 The laboratory’s management system policies related to quality, includes

quality policy statement, defined in a quality manual. The overall objectives are
established and reviewed during management review.

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.

4.2.5 The quality manual includes or references the supporting procedures

including technical procedures and outlines the structure of documentation used.

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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.

 The laboratory shall only claim

conformity with ISO 17025 for this
range of laboratory activities, which
excludes externally, provided
laboratory activities on an ongoing
basis.

5.4 Laboratory activities shall be carried 4.1.2 It is the lab’s responsibility

out in such a way as to meet the
requirements of this document, the
laboratory’s customers, regulatory
authorities and organizations
providing recognition.
to carry out its activities to meet
ISO/IEC 17025 requirement and
to satisfy the needs of
customers, regulatory
authorities, or others providing
recognition.

 This shall include laboratory 4.1.3 The lab system covers

activities performed in all its
permanent facilities, at sites away
from its permanent facilities, in
associated temporary or mobile
facilities or at a customer’s facility.
work carried out in permanent
facilities, at sites away from its
permanent facilities, or in
associated temporary or mobile
facilities.

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5.5 The laboratory shall: ----

 Define the organization and 4.1.5 e) Define the lab structure,

management structure of the
laboratory, its place in any parent
organization, and the
relationships between
management, technical
operations and support services;
its place in a parent company,
and the relationships between
quality management, technical
operations, and support
services.

 Specify the responsibility, 4.1.5 f) Specify the

authority and interrelationship of
all personnel who manage,
perform or verify work affecting
the results of laboratory
activities;
responsibility, authority and
inter-relationships of all
personnel who manage,
perform, or verify work
affecting quality of work.

 Document its procedures to the

extent necessary to ensure the
consistent application of its
laboratory activities and the
validity of the results.

5.6 Does your laboratory have
personnel who, regardless of other
responsibilities, have the authority
and resources needed to carry out
their duties?
4.1.5 a) The laboratory has the
managers and technical
personnel who, irrespective of
other responsibilities, have the
authority and resources needed
to carry out their duties.

Do duties of personnel include: ----

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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?

 Identification of deviations from 4.1.5 a) Identify when

the management system or from deviations occur.
the procedures for performing
lab activities?

 Initiation of actions to prevent or 4.1.5 a) Act to prevent or

minimize any deviations? minimize deviations.

 Reporting to laboratory
management on the performance
of the management system and
any need for improvement?

 Ensuring the effectiveness of 4.1.5 h) Technical management

lab activities? with overall responsibility to
provide the resources needed to
ensure the required quality of
lab operations.

5.7 Does the laboratory management ----

ensure that:
 Communication takes place
regarding the effectiveness of the
management system and the
importance of meeting customer
and other requirements?
4.1.5 k) Ensure that personnel
are aware of the relevance and
importance of their activities
and how they contribute to the
achievement of the objectives of
the management system.

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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.

 The integrity of the 4.2.7 Management ensures that

management system is
maintained when changes to the
management system are planned
and implemented?
the integrity of the management
system is maintained when
changes to the system are
planned and implemented.

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