ISO/IEC 17025
2017/2023
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Management System Requirements
ISO/IEC 17025:2017
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ISO/IEC 17025
2017/2023
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2017/2023
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8.1 Options
8.1.1 General
The laboratory shall establish, document, implement and maintain a
management system that is capable of supporting and demonstrating the
consistent achievement of the requirements of this document and assuring the
quality of the laboratory results.
In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall
implement a management system in accordance with Option A or Option B.
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ISO/IEC 17025
2017/2023
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8.1 Options
8.1.2 Option A
As a minimum, the management system of the laboratory shall address the following:
o Management system documentation (see 8.2);
o Control of management system documents (see 8.3);
o Control of records (see 8.4);
o Actions to address risks and opportunities (see 8.5);
o Improvement (see 8.6);
o Corrective actions (see 8.7);
o Internal audits (see 8.8);
o Management reviews (see 8.9).
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ISO/IEC 17025
2017/2023
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8.1 Options
8.1.3 Option B
Integrating the requirements into an existing ISO 9001 Quality Management
System.
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ISO/IEC 17025
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8.2 Management System Documentation (Option A)
Laboratory management shall establish, document, and maintain policies and objectives.
Policies and objectives shall address the competence, impartiality and consistent
operation of the laboratory.
Laboratory management shall provide evidence of commitment.
All documentation, processes, systems, records, related to the fulfilment of the
requirements shall be referenced from, or linked to the management system.
All personnel involved in laboratory activities shall have access to the documentation, as
applicable.
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8.2 Management System Documentation (Option A)
Level 1
Quality
Manual
System Level 2
Procedures
Test / Calibration Level 3
Instructions (SOPs0
Formats Level 4
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ISO/IEC 17025
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8.3 Control of management system documents (Option A)
The laboratory shall control the documents (internal and external).
o NOTE In this context, “documents” can be policy statements, procedures, specifications,
manufacturer’s instructions, calibration tables, charts, text books, posters, notices, memoranda,
drawings, plans, etc. These can be on various media, such as hard copy or digital.
The laboratory shall ensure that:
a) Documents are approved for adequacy prior to issue by authorized personnel,
b) Documents are periodically reviewed, and updated as necessary,
c) Changes and the current revision status of documents are identified,
d) Applicable documents are available at points of use
e) Distribution control,
f) Documents are uniquely identified,
g) Unintended use of obsolete documents is prevented.
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ISO/IEC 17025
2017/2023
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8.4 Control of Records (Option A)
Laboratory shall establish and retain legible records to
demonstrate fulfilment of the requirements.
Laboratory shall implement the controls needed for the
Identification,
Storage,
Protection,
Back-up,
Archive (Store),
Retrieval,
Retention time, and
Disposal of its records.
laboratory shall retain records for a period consistent with its
contractual obligations.
Records shall be readily available.
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ISO/IEC 17025
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8.5 Actions to address risks and opportunities (Option A)
Laboratory shall consider the risks and opportunities associated with the laboratory
activities.
Laboratory shall plan:
a) Actions to address these risks and opportunities;
b) How to integrate and implement these actions and evaluate the effectiveness of
actions taken.
Actions taken are shall be proportional to the potential impact on the validity of
laboratory results.
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ISO/IEC 17025
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8.5 Actions to address risks and opportunities (Option A)
NOTE 1 Options to address risks can include
Identifying and avoiding threats,
Taking risk in order to pursue an opportunity,
Eliminating the risk source,
Changing the likelihood or consequences,
Sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to
Expanding the scope of the laboratory activities,
Addressing new customers,
Using new technology and other possibilities to address customer needs.
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ISO/IEC 17025
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8.6 Improvement (Option A)
Laboratory shall identify and select opportunities for improvement and implement any
necessary actions.
NOTE Opportunities for improvement can be identified through the review of the
operational procedures, the use of the policies, overall objectives, audit results, corrective
actions, management review, suggestions from personnel, risk assessment, analysis of
data, and proficiency testing results.
Laboratory shall seek feedback, both positive and negative, from its customers.
The feedback shall be analysed and used to improve the
o Management system,
o Laboratory activities and
o Customer service.
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8.7 Corrective actions (Option A)
When a nonconformity occurs, the laboratory shall:
a) React to the nonconformity (NC) and, as applicable:
i. take action to control and correct it,
ii. address the consequences,
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that it does not recur or occur elsewhere, by:
i. Reviewing and analysing the nonconformity,
ii. Determining the causes of the nonconformity,
iii. Determining if similar nonconformities exist, or could potentially occur,
c) Implement any action needed;
d) Review the effectiveness of any corrective action taken;
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ISO/IEC 17025
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8.7 Corrective actions (Option A)
When a nonconformity occurs, the laboratory shall:
a) Update risks and opportunities determined during planning, if necessary;
b) Make changes to the management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
Laboratory shall retain records as evidence of
a) The nature of the nonconformities, cause(s) and any subsequent actions taken,
b) The results of any corrective action.
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8.8 Internal audits (Option A)
Laboratory shall conduct internal audits at planned intervals.
Frequency: 12 months or less
Purpose: Whether the management system
conforms to own requirements, laboratory activities and ISO 17025 Requirements. ,
is effectively implemented and maintained.
Retain records for
Audit Plan
Audit Programme / Schedules
Audit observations
Nonconformity Reports with corrections and corrective actions.
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8.8 Internal audits (Option A)
Scope
Retain
Criteria
Records
Corrective Internal Frequenc
Actions Audit y
Reporting Methods
Responsi
bilities
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ISO/IEC 17025
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8.9 Management reviews (Option A)
The laboratory management shall review its management system at planned intervals.
Frequency: 12 months or less.
Purpose:
To ensure its continuing suitability, adequacy and effectiveness, including the
stated policies and objectives.
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8.9 Management reviews (Option A)
The inputs to management review shall be recorded.
INPUTS (AGENDA):
a) Changes in internal and external issues that are relevant to the laboratory;
b) Fulfilment of objectives;
c) Suitability of policies and procedures;
d) Status of actions from previous management reviews;
e) Outcome of recent internal audits;
f) Corrective actions;
g) Assessments by external bodies;
h) Changes in the volume and type of the work or in the range of laboratory activities;
i) Customer and personnel feedback;
j) Complaints;
k) Effectiveness of any implemented improvements;
l) Adequacy of resources;
m) Results of risk identification;
n) Outcomes of the assurance of the validity of results; and
o) Other relevant factors, such as monitoring activities and training.
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8.9 Management reviews (Option A)
The outputs from the management review shall record all decisions and actions related to
at least:
a) The effectiveness of the management system and its processes;
b) Improvement of the laboratory activities related to the fulfilment of the
requirements of this document;
c) Provision of required resources;
d) Any need for change.
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