General European OMCL Network (GEON)

QUALITY MANAGEMENT DOCUMENT

PA/PH/OMCL (16) 122 R2

MANAGEMENT OF CHANGES

Full document title Management of Changes

and reference PA/PH/OMCL (16) 122 R2
Document type Guideline

Legislative basis Council Directive 2001/83/EC and 2001/82/EC, as amended

Date of first adoption 31st March 2017

Date of original entry 15 April 2017

into force
Date of entry into 1 January 2021
force of revised
document
Previous titles/other Change Control
references / last valid PA/PH/OMCL (16) 122 R
version
Custodian The present document was elaborated by the OMCL Network /
Organisation EDQM of the Council of Europe
Concerned Network GEON

N.B. This OMCL Quality Management System document is applicable to members of the European
OMCL Network only. Other laboratories might use the document on a voluntary basis. However,
please note that the EDQM cannot treat any questions related to the application of the documents
submitted by laboratories other than the OMCLs of the Network.
 PA/PH/OMCL (16) 122 R2 – Management of Changes

MANAGEMENT OF CHANGES

Note: M andatory requirem ents in this guideline are defined using the term s “shall” or
“m ust”. The use of “should” indicates a recom m endation. For these parts of the tex t
other appropriately justified approaches are acceptable. The term “can” indicates a
possibility or an ex am ple w ith non-binding character.

1. Introduction
Management of changes is defined as a systematic way to handle changes within an organisation to
effectively deal with the change and to capitalise on possible opportunities. It involves adapting to
the change, controlling the change and effecting new change.
In ISO/IEC 17025:2017 a specific requirement is given in clause 5.7 b) “Laboratory management
shall ensure that the integrity of the management system is maintained when changes to the
management system are planned and implemented.”
In ISO/IEC 17025:2017, requirements for management of changes are described in several
chapters, including:
• Selection and verification of methods
• Validation of methods
• Process requirements
• Technical records
• Control of data and information management
• Control of management system documents (option A)
• Corrective actions (option A)
• Internal audits

Detailed descriptions of the clauses and quotations from the text are given in Table 1 in
Appendix 1.

Management of changes is also reported as an integral part of the Management Review, being part
of the input and output requirements.

2. Scope
This document is a guideline intended to support OMCLs in the management of changes to the
Management System (MS), including the different steps of the process.

3. Management of changes
The management of changes is a process that ensures that changes are appropriately
• identified,
• documented,
• evaluated (including the impact and consequent risks/opportunities),
• approved,
• planned,
• implemented,
• reviewed.

Management of changes is necessary when a change is considered to have a significant impact, i.e.
on the volume and type of the work, on the range of laboratory activities or on the validity of

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 PA/PH/OMCL (16) 122 R2 – Management of Changes

results. It should not replace the corrective action plan, validation and verification processes, or
management of laboratory equipment.

Every identified change and its impact on the MS needs to be evaluated, possibly using a risk-based
approach.

Typical examples of significant changes are:

• Change from a paper-based system to an electronic system (e.g. LIMS)

• Changes with impact on (performance of) testing fields, scope of batch release
(e.g. systematic research on impurities/contaminations)
• Replacement of animal trials - 3Rs: Replace, Reduce, Refine
• Organisational changes, e.g. fusion of two lab units and relocation or major renovation
• Legal changes with consequences on duties or processes of an OMCL (e.g. governmental or
contractual)
• Changes derived from the management review (e.g. feedback, complaints, audit results, non-
conformities, risks and opportunities, opportunities for improvement, etc.).

Typical examples which would not trigger a change management process include:

• New batch of a chemical substance used in an analytical method and quality defined in the
relevant SOP (change identified to be “within the design space”)
• Change of typical method parameters , e.g. incubation time, temperature (already covered
via validation and verification)
• Change of test equipment (already covered via PQ and verification of test method)
• Any single occurrence or non-conformity covered by the corrective action plan or elsewhere
(e.g. complaint management).
• Changes/amendments to technical records

4. Procedure
The OMCL should ensure that all the steps of a planned change are managed in a controlled and
coordinated manner in order to ensure continual improvement. This can be achieved either by
establishing a specific procedure for change management or by implementing these requirements in
all relevant existing procedures related to change (e.g. project management, method validation,
updates of QMS documents, implementation of actions addressing non-conforming work, risks and
opportunities, etc.) This will help to minimise any disruptions to the laboratory’s work and will
ensure that staff, customers and other interested parties understand and support the change.

The steps depicted in the flowchart in Figure 1 should be considered.

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PA/PH/OMCL (16) 122 R2 – Management of Changes

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 PA/PH/OMCL (16) 122 R2 – Management of Changes

4.1 Identification of the change

The OMCL should define criteria to establish when changes are significant, i.e. triggering change
management. Change and its status should be tracked. This may be supported by unique
identification code.

4.2 Description of the change and evaluation of the impact

A detailed description of the change to the current situation should be reported, describing the
objectives of the change and therefore justifying why it is needed. The OMCL should evaluate the
direct and indirect impact of the proposed change on all relevant areas/laboratory activities and on
the identified risks. The risk if the change is not implemented as well as risks associated with the
change should also be assessed. There are certain types of complex changes (e.g. major change to
facilities, introduction of an electronic laboratory management system) where it may be appropriate
to set up a Project Management Team (or equivalent) responsible for the implementation of such a
change.

A risk analysis should be included in the evaluation of the impact, in order to identify the
opportunities and the actions to mitigate potential risk when the change is implemented (e.g. risk
for impartiality). Several methodologies can be applied to evaluate the impact, i.e. by using
checklists based on, for example, activities of the laboratory, chapters/clauses of the Standard or
areas of the laboratory. The list of clauses in Table 1 can be used as an example.

4.3 Definition of the action plan

Actions to be carried out in order to implement the change shall be planned and reported, as well as
the expected date of effective implementation. The following points should be considered, if
relevant:
• Whenever a validation/re-validation/qualification activity is needed, a plan to support the
control process should be proposed. Where applicable, consider the relevant OMCL
guidelines (e.g. Validation of computerised systems);
• Identification of documents which will need to be updated as a result of the change;
• Identification of training requirements for staff affected by the change;
• Identification of the need for additional resources;
• Development of a communication plan (appropriate people within the OMCL, competent
entities, customers, suppliers, interested parties, etc., who may need to be informed).
It must be noticed that sometimes actions may be defined also in a post-implementation phase.

4.4 Go/no go for action plan

Approval to go ahead for the change and authorisation to rolling out the action plan.

4.5 Action plan follow-up

The following points should be considered during the follow-up/review phase of the action plan:

• Track the status of the change;

• Verify whether each step of the change management process is traceable and appropriately
documented;
• Verify whether each step of the implementation plan was approved, implemented and
completed in a timely manner and whether significant delays were justified;
• If validation/qualification was part of the change implementation, review the
validation/qualification plan and report;
• Verify evidence of training, if applicable;
• Verify whether relevant entities/customers/interested parties were informed.

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 PA/PH/OMCL (16) 122 R2 – Management of Changes

4.6 Implementation of the change

The proposed change should be implemented according to the implementation plan and any
significant delays should be reported and justified. When all relevant actions are closed, the change
is implemented. Record the date of implementation of the change

4.7 Monitoring and review

The purpose of the ongoing monitoring and periodic review is to assure that action plan is
implemented. It should take place overall the stages of the change management process.
Successful implementation of the change and its effectiveness should be checked. An internal audit
may be considered as tool for follow-up of major changes. The results of monitoring and review
should be considered as input of the Management review.

4.8 Change Management responsibilities

In terms of responsibilities, the OMCL should define the personnel responsible for change
management during the different phases, i.e. change identification, definition of the action plan,
evaluation of impacts, approval, review, and implementation of the change. A person responsible for
tracking actions (e.g. related to a specific change, status of ongoing changes, monitoring and
review) on a regular basis should be appointed in the laboratory.

It has to be noted that a change may be expanded, modified or rejected, based on the evaluation
performed during the approval process.

Relevant personnel/interested parties should be informed.

5. References
1) ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration
laboratories
2) ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary

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 PA/PH/OMCL (16) 122 R2 – Management of Changes

APPENDIX 1

Table 1 – Chapters and quotation (full or partial) of the clauses of ISO/IEC 17025:2017 referring to
management of changes.

Chapter Clause
Structural requirements 5.7 “ laboratory management shall ensure that:..b) the integrity of the
management system is mantained when changes to the management
system are planned and implemented”

Review of request, tenders and 7.1.8 “Records of reviews, including any significant changes, shall be
contract retained.”
Control of data and 7.11.2 “...Whenever there are any changes…they shall be authorised,
Information management documented and validated before implementation.”
Reporting results 7.8.8.1 “ when an issued report needs to be changed, amended or re-
issued, any change of information shall be clearly identified and, where
appropriate, the reason for the change included in the report”

Control of management system 8.3.2. “The laboratory shall ensure that: c) changes and the current
documents (option A) versions status of documents are identified”
Corrective actions (option A) 8.7.1 “When a non-conformity occurs, the laboratory shall
f) make changes to the management system, if necessary.”
Internal audit 8.8.2 “The laboratory shall: plan, establish, implement and maintain an
audit programme...which shall take into consideration…changes
affecting the laboratory...”
Management Review 8.9.2. “The inputs to management review shall be recorded and shall
include information related to the following:
a) changes in internal and external issues that are relevant to the
laboratory
h) changes in the volume and type of the work or in the range of
laboratory activities.
8.9.3. The outputs from the management review shall record all
decisions and actions related to at least:
d) any need for change.”

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