‫‪AWARENESS FOR‬‬

‫‪THE ACCREDITATION AGAINST‬‬

‫‪ISO 17025:2017 STANDARD‬‬

‫ك‪ /‬أحمد مدحت‬

‫مدير الجىدة‬
‫شركة مياه الشرب والصرف الصحى بالدقهلية‬
 Certification
&
Accreditation

Ahmed Medhat ISO 17025:2017 20-12-2020

 Certification:

Procedure by which a third party gives

written assurance (certificate of
conformance) that a product, process or
service conforms to specified requirements
(ISO/IEC Guide 2) Using ISO 9001:2015

Ahmed Medhat ISO 17025:2017 20-12-2020

 Accreditation:

Procedure by which an authoritative body

gives formal recognition that a body or
person is competent to carry out specific
tasks (ISO/IEC Guide 2 Using ISO/IEC
17025:2017

Ahmed Medhat ISO 17025:2017 20-12-2020

 AWARENESS
ISO Certification VS Accreditation
Certification is defined as a procedure by which a third
—
party gives written assurance that a product, process, or
service conforms to specified requirements.
(Management)

—Accreditation is defined as a procedure by which an

authoritative body gives formal recognition that a body or
person is competent to carry out specific tasks.

—ertification gives written assurance / confirmation of

C
specified requirements.

—
Accreditation confirms TECHNICAL competence.

Ahmed Medhat ISO 17025:2017 20-12-2020

 REQUIREMENTS COMPARISON

Technical Management

ISO 170xx yes yes

ISO 9001 no yes

Ahmed Medhat ISO 17025:2017 20-12-2020

 WHY ACCREDITATION?

 It is in the interest of competent laboratories

that their competence is verified through a
process of inspection, comparison against
appropriate standards, as confirmation of their
good standing.

 It is also in the interest of customers, of

society and governments that Testing
laboratories operate at high standards of
professional and technical competence.

Ahmed Medhat ISO 17025:2017 20-12-2020

 WHAT ARE THE BENEFITS OF THE
ISO/IEC 17025:2017 STANDARD?

Ahmed Medhat ISO 17025:2017 20-12-2020

WHAT FACTORS SHOULD YOU CONSIDER WHEN
CHOOSING A LABORATORY?
 Qualifications,training and experience of the staff
 Right equipment – properly calibrated and
maintained
 Adequate quality assurance procedures

 Appropriate testing procedures

 Valid test methods

 Traceability of measurements to national

standards
 Accurate recording and reporting procedures

 Suitable testing facilities

Ahmed Medhat ISO 17025:2017 20-12-2020

 ACCREDITATION
IN
QUALITY INFRASTRUCTURE

 Standards

 Metrology

 Accreditation

 Market Surveillance

Ahmed Medhat ISO 17025:2017 20-12-2020

Ahmed Medhat ISO 17025:2017 20-12-2020
Ahmed Medhat ISO 17025:2017 20-12-2020
ACCREDITATION

Standards : Bodies
• ISO/IEC 17011:2017 : Accreditation Bodies
• ISO/IEC 17025:2017 : Cal/ Testing Labs
• ISO 15189:2012 : Medical Labs
• ISO/IEC 17020:2012 : Inspection Bodies •
• ISO/IEC 17021-1:2015 : Systems Certification
• ISO/IEC 17043:2010 : PT Providers
• ISO/IEC 17065:2012 : Products Certification
• ISO/IEC 17024:2012 : Persons Certification
• ISO 17034:2016 : RM producers

Ahmed Medhat ISO 17025:2017 20-12-2020

ACCREDITATION SYSTEM

Ahmed Medhat ISO 17025:2017 20-12-2020

ACCREDITATION SYSTEM
ILAC
 International Laboratory Accreditation Cooperation
 International organisation for accreditation bodies
operating in accordance with ISO/IEC 17011
 Involved in the accreditation of conformity assessment
bodies (CABs ) including:
 Calibration laboratories (using ISO/IEC 17025),
 Testing laboratories (using ISO/IEC 17025),
 Medical testing laboratories (using ISO 15189),
 Inspection bodies (using ISO/IEC 17020),
 Proficiency testing providers (using ISO/IEC 17043) and
 Reference material producers (using ISO 17034)

Ahmed Medhat ISO 17025:2017 20-12-2020

ACCREDITATION SYSTEM
Regional co-operation bodies
 European co-operation for Accreditation
 Asia Pacific Accreditation Cooperation

 African Accreditation Cooperation

 InterAmerican Accreditation Cooperation

 Southern African Development Community

Cooperation in Accreditation

 The Arab Accreditation Cooperation

Ahmed Medhat ISO 17025:2017 20-12-2020
ISO/IEC 17025 REVISION

Revision of ISO/IEC 17025

ISO/IEC 17025 - History
§ ISO Guide 25
§ ISO/IEC 17025:1999
§ ISO/IEC 17025:2005
§ ISO/IEC 17025:2017
§ Transitional period for accredited laboratories is
already determined by ILAC (3 years from date
of publish, i.e Nov 2020)

Ahmed Medhat ISO 17025:2017 20-12-2020

THE EVOLUTION OF ISO/IEC 17025

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO/IEC 17025 INTRODUCTION
The new ISO/IEC 17025:2017:

• A new version of the standard was published by ISO

and the International Electrotechnical Commission
(IEC) in Nov 2017 to update its content and better
serve the laboratories that use it.

• ISO/IEC 17025 was developed by laboratory experts

from all over the world, along with 18 liaison
organizations, such as the International Laboratory
Accreditation Cooperation (ILAC), and many
associations representing laboratories.

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO/IEC 17025 INTRODUCTION
ISO 9001: Quality management system

§ A standard that sets out the requirements for a quality

management system.
§ It helps businesses and organizations to be more efficient and
improve customer satisfaction.
§ This standard is based on a number of quality management
principles:
Ø Process approach
Ø Strong customer focus
Ø Engagement of leadership and people
Ø Relationship management
Ø Continual improvement.
§ Does NOT define the actual quality of your product or service.
The standard helps you achieve consistent results and continually
improve your process.

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2005 STRUCTURE

The international standard

ISO/IEC 17025:2005

General Requirements for the Competence of

Testing and Calibration Laboratories

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2005 STRUCTURE

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2005 STRUCTURE

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2005 STRUCTURE

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2005 STRUCTURE

Ahmed Medhat ISO 17025:2017 20-12-2020

 ISO 17025:2017 REQUIREMENTS

The international standard

ISO/IEC 17025:2017

General Requirements for the Competence of Testing and

Calibration Laboratories

Ahmed Medhat ISO 17025:2017 20-12-2020

KEY CHANGES IN ISO/IEC 17025:2017
ISO/IEC 17025 takes into consideration the ways of the laboratories
today. The most substantive changes are:

• The scope has been revised to cover all laboratory activities,

including testing, calibration and the sampling associated with
subsequent calibration and testing.

• A new structure adopted to align with the other existing ISO/IEC

conformity assessment (CA) standards such as the ISO/IEC 17000
series on CA.

• The process approach to match the newer standards,

‒ Separation of the requirements for structure, resources and testing
or calibration process
- Split of the processes in core processes and supporting processes

Ahmed Medhat ISO 17025:2017 20-12-2020

KEY CHANGES IN ISO/IEC 17025:2017
• Stronger focus on information technologies. Because hard-copy
manuals, records and reports are slowly being phased out for
electronic versions. So recognizes the use of computer, electronic
records, & reports.

• A new section has been added for the concept of risk- based thinking
and acting
- More flexibility in the process documents and its extent
- Consider risks and opportunities

• The terminology has been updated. To include changes like to the

VIM and alignment with ISO/IEC terminology, common terms, and
definitions dedicated to conformity assessment.

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2017 CHANGES
New Terms/Definitions:
Laboratory
Intra-laboratory comparison
Decision rule
Impartiality (more comprehensive)

Obsolete Terms:
Quality manager , Technical manager
Accommodation -> Facility
Preventive actions -> risk mitigation and opportunities

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2017 CHANGES
• Strengthening the responsibility of leadership
− Responsibility for effectiveness of the QMS
− No obligation to formally appoint a quality manager,
instead obligation to employ, instruct and support
appropriate persons

• Documented information
− Classic Quality Manual no further explicitly required
− Sufficient flexibility in handling the
documentation (electronic, paper-based, etc.)

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2017 CHANGES

Management System

Bodies that choose to have a QMS that fulfills all of the

requirements of ISO 9001 shall gain benefit from this
fulfillment (no conflicts!)

- Keep connection to the latest ISO 9001

- Consider principles of ISO 9001

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO /IEC 17025: 2017 CONTENTS

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2017 Terms & definitions
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on
the same or similar items by two or more laboratories in accordance
with predetermined conditions [SOURCE: ISO/IEC 17043:2010, 3.4]
3.4
intralaboratory comparison
organization, performance and evaluation of measurements or tests
on the same or similar items within the same laboratory (3.6) in
accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria
by means of interlaboratory comparisons (3.3)

Ahmed Medhat ISO 17025:2017 20-12-2020

ISO 17025:2017 Terms & definitions
 3.6
laboratory
body that performs one or more of the following activities:
— testing;
— calibration;
— sampling, associated with subsequent testing or calibration

 3.7
decision rule
rule that describes how measurement uncertainty is accounted for
when stating conformity with a specified requirement.
When accepting or rejecting an item, given a specified requirement and
the result of a measurement

Ahmed Medhat ISO 17025:2017 20-12-2020

 RISK MANAGEMENT
 Requires the laboratory to plan and implement actions
to address risks and opportunities.

 Establishes a basis for increasing the effectiveness of the

quality management system, achieving improved results
and preventing negative effects.

 The laboratory is responsible for deciding which risks

and opportunities need to be addressed

Ahmed Medhat ISO 17025:2017 20-12-2020

 WHAT SHOULD WE DO ?
 Identify what the risks and opportunities are in your
organization

 Plan actions to address the risks

- how can I avoid or eliminate the risk?
- how can I mitigate the risk ?

 Implement the plan – take action

 Check the effectiveness of the actions – does it work?

Ahmed Medhat ISO 17025:2017 20-12-2020

 ISO 17025:2017 REQUIREMENTS

Ahmed Medhat ISO 17025:2017 20-12-2020

 ISO 17025:2017 REQUIREMENTS
7.1 Review of RTC ( 4.4)
7.2 Selection of Methods (5.4)
7.3 Sampling (5.7)
7.4 Handling of customer items (5.8)
7.5 Technical records (4.13)
7.6 Evaluation of MU (5.4.6)
7.7 Ensuring the validity of
results(5.9)
7.8 Reporting of results (5.10)
7.9 Complaints (4.8)
7.10 Nonconforming work (4.9)
7.11 Control of data ( 4.13 , 5.4.7 )

Ahmed Medhat ISO 17025:2017 20-12-2020

 ISO 17025:2017 REQUIREMENTS

Ahmed Medhat ISO 17025:2017 20-12-2020

 ISO 17025:2017 REQUIREMENTS

Ahmed Medhat ISO 17025:2017 20-12-2020

Ahmed Medhat ISO 17025:2017 20-12-2020
4.1 IMPARTIALITY
Presence of objectivity
Note 1 :
Objectivity is understood to mean that conflicts of
interest do not exist, or are resolved so as not to
adversely influence the activities of the laboratory.
Note 2 :
Other terms that are useful in conveying the element of
impartiality are freedom from conflicts of interest,
freedom from bias, freedom from prejudice, neutrality,
fairness, open-mindedness, even-handedness,
detachment and balance.

Ahmed Medhat ISO 17025:2017 20-12-2020

4.1 IMPARTIALITY

• The laboratory shall not allow commercial, financial or

other pressures to compromise impartiality

• Laboratory activities shall be structured and managed

so as to safeguard impartiality

• All personnel of the laboratory, either internal or

external, that could influence the conformity assessment
activities, shall act impartially

Ahmed Medhat ISO 17025:2017 20-12-2020

4.1 IMPARTIALITY
4.1.1 Laboratory activities shall be undertaken
impartially.
4.1.2 The laboratory management shall be committed to
impartiality.
4.1.3 The laboratory shall be responsible for the
impartiality of its activities and shall not allow
pressures to compromise impartiality.
4.1.4 The laboratory shall identify risks to its impartiality
on an on-going basis. from (its activities,
its relationships, or relationships of its
personnel).
4.1.5 If a risk to impartiality is identified, the laboratory
shall show how it eliminates or minimizes it.
Ahmed Medhat ISO 17025:2017 20-12-2020
4.2 CONFIDENTIALITY
4.2.1 The laboratory shall be responsible, through legally
enforceable commitments, for the confidentiality.

4.2.2 When required by law or authorized by contractual

arrangements to release information, the customer
is notified.

4.2.3 Information from other sources shall be confidential

Provider of information shall be also confidential

4.2.4 All personnel, internal and external, shall keep

confidential all information.

Ahmed Medhat ISO 17025:2017 20-12-2020

Ahmed Medhat ISO 17025:2017 20-12-2020
 5.1 The laboratory shall be a legal entity, or a defined
partof a legal entity, responsible for its activities.
NOTE : For the purposes of this document, a
governmental laboratory is deemed to be a legal
entity on the basis of its governmental status.

5.2 The laboratory shall identify management that has

overall responsibility for the laboratory.

5.3 The laboratory shall define and document the range of

laboratory activities for which it conforms with this
document. Claim conformity with this range, which
excludes externally provided activities on an ongoing
basis.

Ahmed Medhat ISO 17025:2017 20-12-2020

RANGE OF ACTIVITIES

Ahmed Medhat ISO 17025:2017 20-12-2020

 5.4 Laboratory activities to meet the requirements of this
document, customers, authorities and organizations
providing recognition. Activities performed in all its
permanent facilities, or elsewhere.

5.5 The laboratory shall:

a) define the organization and management structure,
place in any parent organization, relationships
between management, technical and support services;
b) specify responsibility, authority, interrelationship of
all personnel whose work affect the results;
c) document procedures as necessary
to ensure the consistent application.

Ahmed Medhat ISO 17025:2017 20-12-2020

 5.6 The laboratory shall have personnel who,
irrespective of other responsibilities, have the authority
and resources for these duties:

a) implementation, maintenance and improvement of

the management system MS;
b) identification of deviations from MS or procedures
for laboratory activities;
c) initiation of actions to prevent or minimize such
deviations;
d) reporting to laboratory management on the
performance of MS and any for improvement;
e) ensuring the effectiveness of laboratory activities.

Ahmed Medhat ISO 17025:2017 20-12-2020

 5.7 Laboratory management shall ensure that:

a) Communication takes place regarding the

effectiveness of MS and the importance of meeting
customers' and other requirements;

b) The integrity of MS is maintained when changes to

the management system are planned and
implemented.

Ahmed Medhat ISO 17025:2017 20-12-2020

Ahmed Medhat ISO 17025:2017 20-12-2020
 The laboratory shall
have available
personnel, facilities,
equipment, systems
and support services
necessary to manage
and perform its
laboratory activities.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.2 Personnel

Ahmed Medhat ISO 17025:2017 20-12-2020

6.2 Personnel
6.2.1 All personnel, internal or external, that could
influence activities shall act impartially, be
competent, work according to MS.
6.2.2 The laboratory shall document the competence
requirements for each function affecting
activities, including education, qualification,
training, technical knowledge, skills and
experience.
6.2.3 The laboratory shall ensure that the personnel
have the competence to perform responsible
activities & evaluate significance of deviations.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.2 Personnel
6.2.4 Management shall communicate to personnel their
duties, responsibilities and authorities.

6.2.5 The laboratory shall have procedure(s) and retain

records for:
a) determining the competence requirements;
b) selection, training, supervision, authorization,
monitoring competence of personnel.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.2 Personnel
6.2.6 Authorize personnel to perform specific activities,
including but not limited to, the following:

a) verification and validation of methods;

b) analysis of results, & statements of conformity or

opinions and interpretations

c) report, review and authorize of results.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.3 Facilities & environmental conditions
6.3.1 The facilities & environmental conditions shall be
suitable and not adversely affect validity of results.

6.3.2 Requirements for the facilities & environmental

conditions necessary shall be documented.

6.3.3 The laboratory shall monitor, control and record

environmental conditions according to relevant
procedures or where they affect validity of results.
6.3 Facilities & environmental conditions
6.3.4 Measures to control facilities shall be implemented,
monitored and periodically reviewed including:
a) access to and use of areas of laboratory
activities;
b) prevention of contamination or adverse
influences on laboratory activities;
c) effective separation between incompatible
areas.

6.3.5 When the laboratory performs laboratory activities

outside its permanent control, it shall ensure that the
requirements are met.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.4 Equipment

Ahmed Medhat ISO 17025:2017 20-12-2020

6.4 Equipment
6.4.1 The laboratory shall have access to equipment
(including, but not limited to, measuring instruments,
software, measurement standards, reference materials
RM, reference data, reagents, consumables or
auxiliary apparatus) required for the correct
performance of activities & that can influence the
results.
6.4.2 When equipment used outside permanent control, it
shall ensure requirements are met.
6.4.3 The laboratory shall have a procedure
for handling, transport, storage, use,
maintenance of equipment and prevent
contamination or deterioration.
Ahmed Medhat ISO 17025:2017 20-12-2020
6.4 Equipment
6.4.4 The laboratory shall verify that equipment conforms
to specified requirements before placed or returned
into service.
6.4.5 The equipment used for measurement shall be
capable of achieving the measurement accuracy
and/or uncertainty required for a valid result.
6.4.6 Measuring equipment shall be calibrated when:
— the accuracy or uncertainty affects the validity of the
reported results, and/or
— It is required to establish the
metrological traceability of the
reported results.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.4 Equipment
6.4.7 The laboratory shall establish a calibration program,
to be reviewed and adjusted as necessary.
6.4.8 All equipment shall be labeled, coded or otherwise
to allow to readily identify the status of calibration.
6.4.9 Defective Equipment (gives questionable results, or
defective or outside specified requirements, shall be
taken out of service. The laboratory shall examine the
effect of the defect and initiate nonconforming work
procedure (see 7.10).
6.4.10 When intermediate checks are necessary it shall be
carried out according to
a procedure.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.4 Equipment
6.4.11 When correction factors included, the laboratory shall
ensure update and implementation.
6.4.12 The laboratory shall take practicable measures to
prevent unintended adjustments.
6.4.13 Records shall be retained for:
a) the identity of equipment, software & firmware;
b) the manufacturer's name, type identification, and serial
number or other unique identification;
c) evidence of verification of to requirement;
d) the current location;
e) Calibration data;
f) documentation of reference materials data;
g) the maintenance plan and execution;
h) details of any damage / repair.
Ahmed Medhat ISO 17025:2017 20-12-2020
6.5 Metrological traceability

Ahmed Medhat ISO 17025:2017 20-12-2020

6.5 Metrological traceability
• Text held deliberately shorter than previously

• If traceability to SI System through comparative

measurement or use of certified RM

• If technically not possible -> traceability to another

suitable reference (certified RM, reference methods,
consensus-based standards etc.)

• Provision of calibrations through competent actors

• Explanations in an informative Annex A

Ahmed Medhat ISO 17025:2017 20-12-2020

6.5 Metrological traceability
6.5.1 The laboratory shall establish and maintain
metrological traceability of its results by means of a
documented unbroken chain of calibrations. See
Annex A
6.5.2 The laboratory shall ensure that measurement
results are traceable to the (SI) through:
a) calibration provided by a competent laboratory;
b) certified values of CRM provided by
a competent producer with
traceability to the SI;
c) direct realization of the SI
units by comparison, with
national or international standards.
Ahmed Medhat ISO 17025:2017 20-12-2020
6.5 Metrological traceability
6.5.3 When not technically possible, demonstrate
traceability to an appropriate reference, e.g.:

a) Certified values of CRM by

competent producer;
b) Reference measurement
procedures, specified methods
or consensus standards that are
accepted as fit for intended use
with suitable comparison.

Ahmed Medhat ISO 17025:2017 20-12-2020

6.6 Externally provided products & services
Procurement and subcontracting are considered as
externally provided services, in conformity with ISO
9001:2015
Ø No explicit reference to "subcontracting" anymore
Ø External testing and calibration services are basically
treated like external services
Ø Summarized in one section
Therefore:
• Requirements also for control of the ext. provider and
communication to the customer (acceptance criteria
are to be communicated to the customer)
• Definition of criteria for reviewing external products
and services is needed
Ahmed Medhat ISO 17025:2017 20-12-2020
6.6 Externally provided products & services
6.6.1 The laboratory shall ensure that only suitable
externally provided products and services are
used, when such products and services are:
a) intended for incorporation into the Lab’s own activities;
b) are provided as received,
directly to the customer by the laboratory;
c) are used to support the operation of the
laboratory.
6.6.2 The laboratory shall have procedure & records for:
a) defining, reviewing, approving the laboratory’s
requirements for these products/services;
b) defining the criteria for evaluation, selection,
monitoring, re-evaluation of external providers
Ahmed Medhat ISO 17025:2017 20-12-2020
6.6 Externally provided products & services
c) ensuring that these products/services conform to
requirements, before they are used or directly provided
to the customer;
d) taking any actions arising from evaluations,
monitoring, re-evaluations of these providers.
6.6.3 The laboratory shall communicate its requirements to
external providers for:
a) the products and services to be provided;
b) the acceptance criteria;
c) competence, including any required
qualification of personnel;
d) activities that the laboratory, or its customer,
intends to perform at the external provider's
premises.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.1 Review of requests, tenders and contracts
7.1.1 The laboratory shall have a procedure for the review
of requests, tenders and contracts. The procedure
shall ensure that:
a) the requirements are adequately
defined, documented and understood;
b) the laboratory has the capability and
resources to meet the requirements;
c) where external providers are used, the lab
advises the customer of specific activities and gains
the customer's approval;
d) the appropriate methods or procedures are selected
and are capable of meeting the customers' requirements.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.1 Review of requests, tenders and contracts
7.1.2 The laboratory shall inform customer when method
requested is inappropriate or out of date.
7.1.3 When customer requests a statement of conformity to
a specification or standard for the test or calibration,
the specification or standard and the decision rule
shall be clearly defined, communicated to, and
agreed with, the customer
7.1.4 Any differences between the request or tender and
the contract shall be resolved before laboratory
activities commence. Deviations requested by the
customer shall not impact the integrity of the
laboratory or the validity of the results.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.1 Review of requests, tenders and contracts
7.1.5 The customer shall be informed of any deviation from
the contract.
7.1.6 If a contract is amended after work started, contract
review is repeated & amendments communicated.
7.1.7 The laboratory shall cooperate with customers in
clarifying their request and in monitoring lab
performance of their work.
7.1.8 Records of reviews, including any changes, be
retained. This includes discussions with customer
relating requirements or results.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.2 Selection, verification & validation
7.2.1 Selection and verification of methods
7.2.1.1 The laboratory shall use appropriate
methods and procedures for all activities
including evaluation of the uncertainty
and statistical analysis of data.

All methods including instructions, standards,

7.2.1.2
manuals and reference data relevant to activities, shall
be up to date and readily available (see 8.3).

7.2.1.3 Thelaboratory shall ensure it uses latest valid

version of a method unless it is not appropriate or
possible. When necessary, supplemented with
additional details to ensure consistent application.
7.2 Selection, verification & validation
7.2.1.4
When the customer does not specify the method to be used,
the laboratory shall select an appropriate method and
inform the customer of the method chosen.
(recommended methods)
7.2.1.5
The laboratory shall verify that it can properly perform
methods before using them by ensuring required
performance. Records of verification shall be retained. If
method is revised by issuing body, verification shall be
repeated to extent necessary.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.2 Selection, verification & validation
7.2.1.6
When method development is required, this shall be a
planned activity and shall be assigned to competent
personnel equipped with adequate resources. As
development proceeds, periodic review shall be carried
out to confirm the needs of the customer are still
fulfilled. Any modifications to development plan is
approved and authorized.

7.2.1.7
Deviations from methods for all laboratory
activities shall occur only if documented,
justified technically, authorized, and
accepted by the customer.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.2 Selection, verification & validation
7.2.2 Validation of methods
7.2.2.1
The laboratory shall validate
non-standard methods, laboratory-developed
methods and standard methods used outside their
intended scope or otherwise modified. The validation shall
be as extensive as is necessary.
7.2.2.2
When changes are made to a validated method, the
influence shall be determined and where it affects, new
method validation shall be performed.
7.2.2.3
Performance characteristics of validated methods,
shall be relevant to the customers' needs.
7.2 Selection, verification & validation
7.2.2.4 The Lab shall retain the records of
validation:
a) the validation procedure used;
b) specification of the requirements;
c) determination of performance
characteristics of the method;
d) results obtained;
e) a statement on the validity of the
method, detailing its fitness for the
intended use.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.3 Sampling
Procedure shall address all factors
to ensure the validity of results
• laboratory shall have a sampling
plan and documented procedure
• Statement ―analyzed as received‖:
Ø where the laboratory has not been responsible for the
sampling stage
Ø it shall be stated in the reports
• Record of relevant data:
the laboratory shall detail all parameters
• Report shall include all information required to
evaluate MU for subsequent testing or calibration

Ahmed Medhat ISO 17025:2017 20-12-2020

7.3 Sampling
7.3.1 The laboratory shall have a sampling plan and
method when it carries out sampling of
substances, materials or products for subsequent
testing or calibration. The sampling method shall
address the factors to be controlled to ensure validity
of subsequent testing or calibration results. Plan and
method shall be available at the site. Sampling plans
shall, be based on appropriate statistical methods.
7.3.2 The sampling method shall describe:
a) the selection of samples or sites;
b) the sampling plan;
c) the preparation and treatment of sample(s) for
subsequent testing or calibration.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.3 Sampling
7.3.3 The laboratory shall retain records of sampling data
that forms part of the testing or calibration that is
undertaken. Records shall include:
a) reference to the sampling method used;
b) date and time of sampling;
c) data to identify and describe the sample (e.g. number,
amount, name);
d) identification of personnel performing sampling;
e) identification of the equipment used;
f) environmental or transport conditions;
g) diagrams or other equivalent means to identify the
sampling location, when appropriate;
h) deviations, additions to or exclusions from the
sampling method and sampling plan.
7.4 Handling of test / calibration items
7.4.1 The laboratory shall have
a procedure for the handling, up
to disposal or return of test or
calibration items. To avoid
deterioration/damage . Handling
instructions, if any, shall be followed.

7.4.2 The laboratory shall have a system for the

identification of test / calibration items
while under its responsibility. Items
will not be confused physically
or in records or other documents.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.4 Handling of test / calibration items
7.4.3 Upon receipt of the test / calibration item, deviations
from specified conditions shall be recorded. When
there is doubt about suitability the customer is
consulted before proceeding and consultation is
recorded. The laboratory includes a disclaimer in the
report indicating which results may be affected.

7.4.4 When items need to be stored or conditioned under

specified environmental conditions, these conditions
shall be maintained, monitored and recorded.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.5 Technical records
7.5.1
The laboratory shall ensure that technical records for each
laboratory activity contain what enable the repetition of
the activity under conditions similar to the original.

The technical records shall include the date and the

identity of personnel responsible for each activity and for
checking data and results.

Original observations, data and calculations shall be

recorded at the time they are made and shall be
identifiable with the specific task.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.5 Technical records
7.5.2
The laboratory shall ensure that amendments to technical
records can be tracked to previous versions or to original
observations.

Both the original and amended data and files shall be

retained, including the date of alteration, the
altered aspects and personnel responsible.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.6 Evaluation of meas. uncertainty
7.6.1
Laboratories shall identify the contributions to
measurement uncertainty. When evaluating, all
contributions of significance, including from sampling,
shall be taken into account using appropriate methods of
analysis.

7.6.2
A calibration laboratory, shall evaluate the measurement
uncertainty for all calibrations.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.6 Evaluation of meas. uncertainty
7.6.3
A testing laboratory shall evaluate measurement
uncertainty.
Where the test method precludes rigorous evaluation of
measurement uncertainty,
an estimation shall be made based on theoretical
principles or practical experience of the performance of the
method.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.7 Ensuring the validity of results
• Laboratory shall have procedures for regular
monitoring of the effectiveness of QA measures
• Selection of surveillance measures:
Ø Use of reference materials
Ø Intermediate checks
Ø Repetition of tests or calibrations
Ø Internal comparisons
Ø Blind tests
• Comparisons with other laboratories (e.g. PT and
comparative tests): whenever available and suitable
• Results shall be analyzed to achieve improvements

Ahmed Medhat ISO 17025:2017 20-12-2020

7.7 Ensuring the validity of results
7.7.1 The laboratory shall have a procedure for
monitoring the validity of results. The data shall be
recorded to detect trends and use statistics.
Monitoring shall be planned / reviewed including:
a) use of RM or QC materials;
b) use of alternative calibrated instruments;
c) use of working standards with control charts;
d) intermediate checks on measuring equipment;
f) replicate tests/calibrations -same/different methods g)
retesting/ recalibration of retained
items;
i) review of reported results;
j) Intra-laboratory comparisons;
k) testing of blind sample(s).
7.7 Ensuring the validity of results
7.7.2
The laboratory shall monitor its performance by
comparison with other laboratories. This shall be planned
and reviewed and shall include:
a) participation in proficiency testing PT;
b) participation in inter-laboratory comparisons other
than proficiency testing.
7.7.3
Data from monitoring activities shall be analyzed, used to
control and improve the activities. If the results of the
analysis of data are found to be outside pre-defined
criteria, appropriate action shall be taken to prevent
incorrect results from being reported.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
• Content given by the customer shall be identified

• No "signature" required anymore (but an "identification"

of a person authorizing the report)

• Texts on "statement of conformity" now in this section

together with "opinions and interpretations

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
7.8.1 General
7.8.1.1 The results shall be reviewed and authorized prior
to release.
7.8.1.2 The results shall be provided accurately, clearly,
usually in a report (e.g. a test report or a
calibration certificate or report of sampling), and shall
include all the information agreed with the customer
and necessary for the interpretation of the results and
all information required by the method used. All
issued reports shall be retained as technical records.
7.8.1.3 When agreed with the customer, the results may be
reported in a simplified way. Any information not
reported to the customer shall be readily available.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.8 Reporting of results
7.8.2 Common requirements for reports (test/cal/sampl)
7.8.2.1 Each report shall include at least the information
listed, unless the laboratory has valid reasons for not
doing so. (note for no reproduction)

7.8.2.2The laboratory shall be responsible for all the

information provided in the report, except when
provided by the customer. Data provided by a
customer shall be clearly identified. A disclaimer shall
be put on the report when the information by the
customer can affect the validity of results. Where the
Lab is not responsible for sampling, it shall state in
the report that the results apply to the sample
as received.
7.8 Reporting of results
7.8.3 Specific requirements for test reports
7.8.3.1
In addition to the requirements listed in 7.8.2, test
reports shall include:
a) information on specific test conditions, such as
environmental conditions;
b) where relevant, a statement of conformity with
requirements or specifications (see 7.8.6);
c) the measurement uncertainty presented in the same
unit or percent when:
— relevant to the validity or application;
— a customer's instruction so requires, or
— it affects conformity to a specification limit;
Ahmed Medhat ISO 17025:2017 20-12-2020
7.8 Reporting of results
d) where appropriate, opinions and interpretations;
e) additional information required by specific
methods, authorities, customers.

7.8.3.2
Where the laboratory is responsible for the sampling
activity, test reports shall meet the requirements listed in
7.8.5 where necessary for the interpretation of test
results.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
7.8.4 Specific requirements for calibration
certificates
7.8.4.1 In addition to the requirements listed in 7.8.2,
calibration certificates shall include the following:
a) measurement uncertainty of the result presented
in the same unit or percent;
b) the conditions (e.g. environmental) under which the
calibrations were made;
c) a statement identifying how the measurements are
metrologically traceable (see Annex A);
d) the results before and after any adjustment or repair;
e) where relevant, a statement of conformity with
requirements or specifications (see 7.8.6);
f) where appropriate, opinions and interpretations
7.8 Reporting of results
7.8.4.2
Where the laboratory is responsible for the sampling
activity, calibration certificates shall meet the
requirements listed in 7.8.5.

7.8.4.3
A calibration certificate or calibration label shall not
contain any recommendation on the calibration interval,
except where this has been agreed with the customer.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
7.8.5 Reporting sampling – specific requirements
Where the laboratory is responsible for the sampling, reports
shall include the following:
a) the date of sampling;
b) unique identification of the item or material sampled
(including the name of the manufacturer, the model
or type of designation and serial numbers);
c) the location of sampling, including any diagrams,
sketches or photographs;
d) a reference to the sampling plan and method;
e) details of any environmental conditions during sampling
that affect the interpretation;
f) information required to evaluate uncertainty for
subsequent testing or calibration.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.8 Reporting of results
7.8.6 Reporting statements of conformity
7.8.6.1 When a statement of conformity to a specification or
standard is provided, the Lab shall document the
decision rule employed, taking into account the level of
risk associated with the decision rule employed, and
apply the decision rule.
7.8.6.2 The laboratory shall report on the statement of
conformity, which clearly identifies:
a) to which results this statement applies;
b) which specifications, standards or parts thereof are
met or not met;
c) the decision rule applied (unless it is inherent in
the requested specification or standard).
Ahmed Medhat ISO 17025:2017 20-12-2020
7.8 Reporting of results
• Laboratories often make statements on conformity of the
results with certain specifications (compliance with limits,
test passed (yes/no), etc.)

• Clear decision rules are to be communicated, documented

and to be applied

• When reported information associated with a calibration

not includes measurement results and MU:
Ø Addition of a statement required:
data is not intended to be used in support of the further
dissemination of traceability (e. g. to calibrate another
device)

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
7.8.7 Reporting opinions and interpretations
7.8.7.1
When opinions and interpretations are expressed, the
laboratory shall ensure that only personnel authorized
releases the respective statement. The laboratory shall
document the basis upon which they have been made.
7.8.7.2
The opinions and interpretations expressed in reports
shall be based on the results obtained from the tested or
calibrated item and shall be clearly identified as such.
7.8.7.3
When opinions and interpretations are directly
communicated by dialogue with the customer,
a record of the dialogue shall be retain
Ahmed Medhat ISO 17025:2017 20-12-2020
7.8.7 Opinions and interpretations
• Opinions and interpretations shall be clearly identified
Always keep reference to the result of the tested or
calibrated item

• To be given only by authorized personnel (experience)

Bases for the statements made have to be documented

• Clear dissociation from assessments/evaluations in the

context of inspections and product certifications has to
be required

Ahmed Medhat ISO 17025:2017 20-12-2020

7.8 Reporting of results
7.8.8 Amendments to reports
7.8.8.1 When an issued report needs to be changed,
amended or re-issued, any change shall be clearly
identified and the reason for included in the report.
7.8.8.2 Amendments to a report after issue shall be made
only in the form of a further document, or data
transfer, including the statement ―Amendment to
Report, serial number...‖, or equivalent wording.
Amendments shall meet all the requirements.
7.8.8.3 When it is necessary to issue
a complete new report, this
shall be uniquely identified and shall
contain a reference to the original
that it replaces.
7.9 Complaints
7.9.1 The laboratory shall have a documented
process for complaints.
7.9.2 Handling process for complaints shall
be available to any interested party
on request. Confirm whether the
complaint relates to Lab activities on
receipt. The laboratory shall be responsible for all
decisions on all levels.
7.9.3 The process for handling complaints shall include at
least the following elements and methods:
a) description of the process from receiving, to
deciding on actions to be taken;
b) tracking and recording complaints, including
actions undertaken to resolve them;
c) ensuring that any appropriate action is taken.
Ahmed Medhat ISO 17025:2017 20-12-2020
7.9 Complaints
7.9.4
The laboratory receiving the complaint
shall be responsible for gathering
and verifying all necessary information
to validate the complaint.
7.9.5
the laboratory shall acknowledge receipt of the complaint, and provide
progress reports and outcome. If possible
7.9.6
The outcomes to be communicated to the complainant shall be
made/reviewed/approved by, individual not involved in the activities in
question.
7.9.7
Whenever possible, the laboratory shall give formal notice of end of
complaint handling to complainant

Ahmed Medhat ISO 17025:2017 20-12-2020

7.10 Nonconforming work
7.10.1
The laboratory shall have a procedure
that shall be implemented when
any aspect of its laboratory activities
or results of this work do not conform to its own procedures
or the agreed requirements of the customer. The procedure
shall ensure that:
a) the responsibilities and authorities defined for the
management of nonconforming work;
b) actions (including halting or repeating of work and
withholding of reports, as necessary) are based upon
the risk levels established by Lab;
c) an evaluation is made of the significance of
the nonconforming work, (impact on previous);
7.10 Nonconforming work
d) a decision is taken on the acceptability of the
nonconforming work
e) where necessary, the customer is notified and work is
recalled;
f) the responsibility for authorizing the resumption of
work is defined.
7.10.2 The laboratory shall retain records of nonconforming
work and actions in 7.10.1.
7.10.3 Where the evaluation indicates that the
nonconforming work could recur, or that there is
doubt about the conformity of the laboratory's
operations with its own management system,
the laboratory shall implement corrective action
Ahmed Medhat ISO 17025:2017 20-12-2020
7.11 Control of data/ info management
7.11.1 The laboratory shall have access to the data and
information needed to perform laboratory activities.
7.11.2 The laboratory information management system
(LIS) used for the collection, processing, recording,
reporting, storage or retrieval of data shall be
validated for functionality, including interfaces by
the laboratory before introduction. Whenever there
are any changes in configuration, modifications to
commercial off-the-shelf software, they shall be
authorized, documented, validated before use.
7.11.3 The LIS shall:
a) be protected from unauthorized access;
b) be safeguarded against tampering and loss;
Ahmed Medhat ISO 17025:2017 20-12-2020
7.11 Control of data/ info management
c) be operated in an environment that complies with
specifications or, for manual system, in conditions to
safeguard recording/ transcription
d) ensure the integrity of the data / information;
e) include recording system failures and the
appropriate immediate and corrective actions.
7.11.4
When a laboratory information management system is
managed and maintained through an external provider,
the laboratory shall ensure that it complies with all
applicable requirements of this document.

Ahmed Medhat ISO 17025:2017 20-12-2020

7.11 Control of data/ info management
7.11.5 The laboratory shall ensure that instructions,
manuals and reference data relevant to the
laboratory information management system(s) are
made readily available to personnel.

7.11.6 Calculations and data transfers shall be checked in

an appropriate and systematic manner.

Ahmed Medhat ISO 17025:2017 20-12-2020

Ahmed Medhat ISO 17025:2017 20-12-2020
8. Management System Requirements
Minimum MS requirements of the laboratory
(Option A):

• management system documentation

• control of management system documents
• actions to address risks and opportunities
• control of records
• improvement
• corrective action
• internal audits
• management review

Ahmed Medhat ISO 17025:2017 20-12-2020

8.1 Options
8.1.2 Option A
• As a minimum, the management system of the
laboratory shall address the elements of the standard.

8.1.3 Option B
• A laboratory that has established and maintains a
management system, in accordance with the
requirements of ISO 9001, and capable of supporting
and demonstrating the consistent fulfillment of the
requirements of Clauses 4 to 7, also fulfills at least the
intent of the management system requirements
specified in 8.2 to 8.9

Ahmed Medhat ISO 17025:2017 20-12-2020

8.2 MS Documentation
• Establish, document, and maintain policies and
objectives, ensure that the policies and objectives are
acknowledged and implemented
• Policies and objectives address the competence,
impartiality and consistent operation
• Evidence of commitment to development and
implementation of MS and continuous improving
• All documentation/alternatives, be included in,
referenced from, or linked to the MS.
• All personnel have access to parts of the MS
documentation and related to their responsibilities

Ahmed Medhat ISO 17025:2017 20-12-2020

8.2 MS Documentation
• Determine necessary degree of documentation
• Stronger link to electronic data (data protection,
monitoring changes, storage)
• Requirements for information management systems
(interfaces, verification of functionality, etc.), target:
data integrity
• Software changes: Modification of commercially
available systems requires validation, authorization and
documentation
• Technical records shall be maintained in a way which
allows the repetition of laboratory activities

Ahmed Medhat ISO 17025:2017 20-12-2020

8.3 Control of MS Documents
• The laboratory control the documents (internal and
external)
• statements, procedures, specifications, manufacturer’s
instructions, calibration tables, charts, text books,
posters, notices, memoranda, drawings, plans, etc.
• Ensure that documents are :
• Approved by authorized
• Periodically reviewed
• Changes /current revision are
identified
• Relevant versions available,
distribution controlled
• Uniquely identified
• obsolete documents identified and retained
8.4 Control of records
• Establish and retain legible records to demonstrate
fulfillment of the requirements in this document.

• Identification, storage, protection,

back-up, archive, retrieval, retention time
, and disposal of its records.

• Retain records as its contractual obligations. Access

to records be confidential, and records be readily
available

Ahmed Medhat ISO 17025:2017 20-12-2020

8.5 Actions to address risks/ opportunities
• Consider risks / opportunities associated with the
laboratory activities in order to:
Ø Achieve its intended results.
Ø Opportunities to achieve objectives
Ø Prevent, or reduce, undesired impacts.
Ø Achieve improvement • Plan for: actions to risks and
opportunities - integrate action in MS - evaluate
effectiveness.
• Actions taken proportional to the potential impact

no requirement for formal methods for risk management or a

documented risk management process

Ahmed Medhat ISO 17025:2017 20-12-2020

Risk based approach
Options to Address:
• 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

Ahmed Medhat ISO 17025:2017 20-12-2020

Risk based approach
Consequences:
• ―preventive measures― no longer explicitly stated,
because prevention is a core task of quality
management and risk based approach

• No formalized risk management required

• Expression of measurement uncertainty as conceptual

basis for dealing with the risk of a measurement
result

• Accreditation: difficult to assess

Ahmed Medhat ISO 17025:2017 20-12-2020

8.6 Improvement
• Identify/ select opportunities for improvement/
implement necessary actions.

• Seek feedback, both positive and negative, from its

customers. Feedback analyzed and used to improve
the MS, Lab activities and customer service

Ahmed Medhat ISO 17025:2017 20-12-2020

8.7 Corrective actions
• When a nonconformity occurs:
Ø take action to control and correct it
Ø address the consequences
Ø Evaluate need for action to eliminate
the cause, to not reoccur or occur elsewhere
Ø Implement any action needed
Ø Review the effectiveness
Ø Update risks and opportunities
Ø Make changes to the MS
• Corrective actions appropriate to the effects
• Retain records as evidence for NC, action, results of
CARs

Ahmed Medhat ISO 17025:2017 20-12-2020

8.8 Internal audits

Ahmed Medhat ISO 17025:2017 20-12-2020

8.8 Internal audits
• At planned intervals to assure MS:
Ø conforms to: own MS, & Std requirements
Ø effectively implemented and maintained

• There shall be:

Ø Plan audit program, consider importance of
activities, changes, results of previous audits
Ø Define criteria and scope
Ø Ensure results reported to management
Ø Implement actions without undue delay;
Ø Retain records as evidence of implementation of
program and results.

Ahmed Medhat ISO 17025:2017 20-12-2020

8.9 Management reviews

Ahmed Medhat ISO 17025:2017 20-12-2020

8.9 Management reviews
• At planned intervals to ensure continuing suitability,
adequacy and effectiveness of MS

• The inputs recorded and include:

Ø Information related to all 15 inputs mentioned
in the standard.
• Outputs record all decisions and actions related to at
least:
Ø Effectiveness of MS and its processes
Ø Improvement of activities related
to standard
Ø Provision of required resources.
Ø Any need for change
Ahmed Medhat ISO 17025:2017 20-12-2020
Ahmed Medhat ISO 17025:2017 20-12-2020