Guideline for the Formulation of Scopes of

Accreditation for Laboratories

ILAC-G18:04/2010
 Copyright ILAC 2010

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ILAC-G18:04/2010

Guideline for the Formulation of Scopes of Accreditation for Laboratories

TABLE OF CONTENTS

PREAMBLE ......................................................................................................................................... 4

PURPOSE ............................................................................................................................................. 4

AUTHORSHIP ..................................................................................................................................... 4

1. GENERAL .................................................................................................................................. 5

1.1 Scope of accreditation ............................................................................................................... 5

1.2 References ................................................................................................................................... 5

2. THE DEFINITION OF THE SCOPE OF ACCREDITATION............................................. 6

2.1 Scope description ........................................................................................................................ 6

2.2 Flexible scope .............................................................................................................................. 7

3. ASSESSMENT OF SCOPES..................................................................................................... 8

3.1 Staff competence......................................................................................................................... 8

3.2 Method development and modification .................................................................................... 9

3.3 Validation .................................................................................................................................... 9

3.4 Documentation.......................................................................................................................... 10

3.5 Responsibilities ......................................................................................................................... 10

4. SPECIFIC REQUIREMENTS FOR THE ON-SITE ASSESSMENT ................................ 10

4.1 General ...................................................................................................................................... 10

4.2 Flexible scope ............................................................................................................................ 11

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Guideline for the Formulation of Scopes of Accreditation for Laboratories

PREAMBLE

The scope of accreditation of a laboratory is the formal and precise statement of the activities which
the laboratory is accredited for. It is as such the result of a combination of information (scope
parameters) concerning the field of activity (e.g. testing, calibration), the product/object tested or
calibrated and the methods and procedures used. The assessment (and reassessment) of the scope of
accreditation represents the core of the accreditation process and may be defined as the set of
operations carried out by the Accreditation Body in order to ensure, with an adequate degree of
confidence, that the laboratory has the competence to provide reliable services within the defined
scope.

Accredited laboratories may be allowed to modify their own laboratory-developed methods or to use
up-dated versions of standard methods and standards they are accredited for and to introduce similar
new methods without having to report to the Accreditation Body in advance, provided that these
modifications and up-dated versions or new methods do not incorporate new measurement principles
that are not covered by the original description of the scope. The flexibility of a laboratory in this
respect is described by a flexible scope. The concept of flexible scope according to ISO/IEC 17025,
Clauses 5.4.3 and 5.4.4, and Clauses 5.5.1 to 5.5.3 of ISO 15189 has found broad acceptance all over
the world. There are many benefits of this concept. For the Accreditation Body, it provides a means
for better service to the laboratory, less administrative work, more time to concentrate on technical
aspects of accreditation, and fewer unexpected surveillance visits for enlarging or modifying the
scope of accreditation. For the laboratory, it allows in-time adaptation of their methods to the needs of
new products, manufacturers and conformity procedures, as well as to the technology involved.

Accreditation bodies around the world are offering accreditation of flexible scope according to
ISO/IEC 17025, Clauses 5.4.3 and 5.4.4, and Clauses 5.5.1 to 5.5.3 of ISO 15189. There are however
still differences between interpretations of the term flexible scope and the way it is implemented in
different countries. For example, a number of Accreditation Bodies apply flexible scope in specific
fields only. Laboratories and their customers may therefore have difficulties understanding the
concept of flexible scope and there is also a need to ensure that this concept is applied consistently at
an international level.

PURPOSE

The purpose of this publication is to provide information on how to define the scope of accreditation
(fixed and flexible) and to identify criteria and ways of assessing the scope in order to allow an
effective and harmonised application among Accreditation Bodies in relation to the relevant
international Standards.

AUTHORSHIP

ILAC G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the
Assessment of the Scope in Testing was developed by the then ILAC committee on Technical
Accreditation Issues, and approved for publication by the ILAC General Assembly in 2001. ILAC
G18:2002 was revised in 2008/9 by the ILAC Accreditation Committee (AIC) to produce this
publication.

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Guideline for the Formulation of Scopes of Accreditation for Laboratories

1. GENERAL

1.1 Scope of accreditation

The scope of accreditation of a testing, calibration or medical laboratory is the official and
detailed statement of the activities for which the laboratory is accredited. In ISO/IEC
17011:2004 Clause 7.9.4 it is required that the accreditation body shall provide an accreditation
certificate to the accredited laboratory which shall provide a brief indication of, or reference to,
the scope of accreditation while Clause 7.9.5 requires that the accreditation certificate or an
annex to it shall identify:
- the tests or types of tests performed and materials or products tested and, where
appropriate, the methods used (for testing laboratories)
- the calibrations, including the types of measurements performed, the Calibration and
Measurement Capability (CMC) [historically and used by ISO/IEC 17011: Best
Measurement Capability (BMC)] or equivalent (for calibration laboratories)

In addition ISO/IEC 17011 Clause 8.2.1 requires that the accreditation body shall make
publicly available information about the current status of the accreditations, which shall be
updated regularly. The information shall include scopes of accreditation, condensed and/or in
full. If only condensed scopes are provided, information shall be given on how to obtain full
scopes.

The formulation and assessment of the scope of accreditation represents the core of the
accreditation process. The role of the Accreditation Body is to ensure (to an adequate degree of
confidence) that the laboratory has the competence to offer the service defined in the scope.

According to Clauses 5.4.3 and 5.4.4 of ISO/IEC 17025 and Clauses 5.5.1 to 5.5.3 of ISO
15189 accredited laboratories may modify methods. In the context of accredited laboratories,
such modifications require the laboratory to have a flexible scope of accreditation. The basic
consequence of a flexible scope and the benefit to the laboratory has the acknowledged
flexibility, to modify methods, validate the changes and apply them without having to ask the
Accreditation Body for extensions to the scope. Such modifications to methodology must not
incorporate new measurement principles not previously covered in the scope of accreditation.

1.2 References

ISO/IEC 17011:2004 General requirements for accreditation bodies accrediting

conformity assessment bodies

ISO/IEC 17025:2005 General requirement for the competence of testing and calibration
laboratories

ISO 15189:2007 Medical laboratories - Particular requirements for quality and

competence

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Guideline for the Formulation of Scopes of Accreditation for Laboratories

2. THE DEFINITION OF THE SCOPE OF ACCREDITATION

2.1 Scope description

The scope of accreditation can be clearly defined by parameters such as described in Table 1.

Table 1: Typical parameters for description of the scope of accreditation

Testing laboratory Calibration laboratory Medical laboratory

Testing field Calibration field Medical field
(e.g. environmental testing or (e.g. dimensional measurements) (e.g. clinical chemistry,
mechanical testing) hematology)
Type of test - Examination technique
(e.g. mass spectrometry or (e.g. IR spectrometry)
hardness testing)
Test object or product Calibration objects Biological samples
(e.g. automotive components); (e.g. gauge blocks) (e.g. whole blood, serum,
Matrices (e.g. tap water) body fluid)

Test parameter (when Quantity, property Components / Analytes

appropriate) (e.g. length) (e.g. CO2) or related groups
(e.g. Shore hardness) of analytes (e.g. liver
function)*
Reference to standardised Reference to standardised procedure Reference to standardised
method (when appropriate and applicable) procedure (when appropriate
(e.g. ISO 14577-1:2003) and applicable)
Internal method reference Internal calibration procedure Internal examination
reference procedure reference
- Calibration and Measurement -
Capability (CMC)

* If the laboratory has flexible scope, test parameters/components/analytes may not be

specified.
- Indicates that this scope parameter is not relevant in the specific field

The methods/calibration or examination procedures is usually an important reference to give in

the scope and may be specific or generic and can be based on standard methods or laboratory-
developed methods:

Non standard or laboratory-developed methods are developed by the laboratory itself or

other parties, or adapted from standard methods and validated.

Standard methods are developed by a standardisation body or other well-established

organisations whose methods are generally accepted by the technical sector in question.

In describing the scope of the laboratory it is relevant in some cases to give both a reference to
a standardised method as well as an internal method reference (in the quality management
system). In other cases this is not relevant.

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Guideline for the Formulation of Scopes of Accreditation for Laboratories

Depending on the type of laboratory activity, more emphasis can be given to one or more of
the scope parameters described in Table 1. If, for example, range and uncertainty is omitted in
the description of the scope this does not mean that the laboratory shall not answer for those
details. It is only not needed in order to characterise the scope of the laboratory. This will have
an impact on the way the scope will be presented and assessed.

Conventionally, the scope of accreditation is described using a fixed list of all methods/
calibration or examination procedures which the laboratory can use when referring to
accredited status. This list is usually an annex to the certificate of accreditation and gives the
details in the scope of accreditation.

Granting a laboratory a flexible scope provides the possibility of describing major sub
disciplines of the laboratory activities in a more general form. The laboratory must anyway
retain a current list of methods covered by accreditation including newly modified, introduced
or developed methods.

The fact that a laboratory is entitled to introduce new or modified methods shall be made clear
to the market and to the customer through reference in the scope. This reference should avoid
any potential impression that this is a form of classification of laboratories.

2.2 Flexible scope

When a laboratory is granted a flexible scope, it is allowed to include additional activities in

its scope of accreditation on the basis of its own validations without evaluation by the
accreditation body prior to operation of the activity. The possibility of introducing new,
modified or developed methods under flexible scope does not include introduction of new
measurement principles of testing, calibration or examination not previously covered by the
scope of accreditation. Flexible scope can be established based on degrees of freedom for
flexibility such as:
Flexibility concerning object/matrix/sample
This means flexibility that allows for changes with respect to various products (e.g.
change in matrices) within a product area. For example this covers HGA atomic
absorption spectroscopy which is extended from determination of cadmium in fruit,
jams and other fruit products for the determination of cadmium in cereals and bakery
products. Another example is mechanical testing of various components (e.g. wheels,
suspensions) for automotive applications.
Flexibility concerning parameters/components/analytes
This means flexibility that allows for changes with respect to parameters. An
example is the extension of cadmium determination in food to other trace metals by
HGA atomic absorption spectroscopy.
Flexibility concerning the performance of the method
This means flexibility that allows for changes in the performance of the method for a
given specimen type and a given parameter. This includes for example, the
modification of measuring range and uncertainty.
Flexibility concerning the method
This means flexibility which allows adoption of methods that are equivalent to
methods already covered by accreditation. An example is the extension of in-plane
displacement field measurement by 2D-ESPI (electronic speckle pattern
interferometry) to three dimensional distribution of the displacement by 3D-ESPI.

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Guideline for the Formulation of Scopes of Accreditation for Laboratories

In formulating the flexible scope it is important that accreditation is not granted for a specific
measurement procedure and that the limits of the flexibility are clearly set. It is understood that
a flexible scope and a fixed scope can be separately described or combined within one
accreditation whatever is the most convenient. In all cases, the laboratory must retain an
updated list of all methods for which accreditation is held, including newly modified,
introduced or developed methods for review by the Accreditation Body.

In calibration, possibilities for flexible scopes are more limited than in testing. It is thus not
possible to have a flexible scope in calibration, which concerns the performance of the method
in relation to the CMC. It is also not possible in calibration to have flexibility concerning
parameters (quantities) as different quantities require completely different measurement
techniques. The possibility for flexibility with respect to objects is in some cases generically
included and need not be specified as such in the scope of accreditation. This is the case in
electrical calibration where scopes usually are specified in quantities and apply to any
instrument which can be connected to the measurement set-up. In calibration most methods are
also self developed measurement procedures and as far as changes to those makes no change
to the CMC and use the same techniques, then those procedures can be updated as other
documents in the laboratorys quality management system. This inherent flexibility does not
need to be specified in the scope of accreditation as it applies to all calibration laboratories.

3. ASSESSMENT OF SCOPES

3.1 Staff competence

Evaluation of the technical competence at all hierarchical levels and for all functions of a
laboratory is one of the core responsibilities of Accreditation Bodies when assessing
laboratories competence. The competence of staff can be obtained and demonstrated in
various ways such as:

- General knowledge in the domain which the clients of the laboratory are working in.
- Knowledge about risks the clients are dealing with and how they intend to use the
results.
- Knowledge about the procedures applied, about their reliability, including the
associated uncertainties. The individual components contributing to the uncertainty
of these procedures.
- Formal education and the years of experience in the respective field.
- Training courses in the past years and the effect of these training courses.
- Cooperation with scientific organisations, standardisation organisations, national and
international organisations contributing to the development of the techniques and
application of conformity assessments procedures and its use in the field.
- Internal learning and improvement processes due to audits, reviews, cooperation with
clients.

When a laboratory develops a new or a modified method special attention must be given to the
competence of the staff. The staff who undertake development and modification of methods
shall have the necessary technical understanding of the test method and the technology used.
They shall be able to judge the suitability of methods and the quality of the results obtained.
This competence can be obtained and demonstrated in various ways such as:

- Formal education and training received,

- Experience within the field,

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- Participation in research or development projects,

- Participation in standardisation committees,
- Participation in scientific or authoritative committees.

Accreditation Bodies should assess staff who are authorised to develop and validate methods
in order to assess them for this capability. The evaluation should be more comprehensive if the
laboratory operates a flexible scope and should include documented evidence that the
laboratory operates all steps involved in the development and operation of methods within the
flexible scope.

3.2 Method development and modification

The laboratory that undertakes development and modification of methods should meet criteria
such as:

- Procedures that cover development and approval of methods,

- Authorisation of experienced staff who are responsible for development and
validation of new and modified methods,
- Records covering the full process from development, validation and verification,
- Management commitment to sustain a flexible scope if accredited for this.

Procedures and responsibilities for development, implementation and validation of modified,

updated or introduced methods shall be described in detail within the quality documentation.
The responsible staff will have to state the minimum quality requirements before starting the
process of validation and implementation, or even better, before starting the whole
development process.

An experienced person should be authorised by the management for each designated technical
sector to take the overall responsibility for modification, development and implementation of
new or revised methods.

Modifications and up-dates of test methods or development activities including all the
underlying results and other relevant data must be controlled and maintained on record. This
data shall be available to the Accreditation Body which has to check it during a surveillance
visit, a reassessment or on request.

The responsible staff (including those responsible for quality management) shall regularly
review the modified, revised or newly developed methods. Procedures and responsibilities
linked to the development or revision of accredited methods shall be reviewed periodically by
the responsible management taking into account the results of internal and external quality
control. Records of these review activities must be made available to the Accreditation Body.

3.3 Validation

New and modified methods must be validated and the laboratorys capability to perform the
method verified before it can be included in the scope of accreditation. Where the method is a
standard method, validation is not required but verification must be undertaken.

In the case of free selection of standard methods or its equivalent method within a defined
field or area of testing validation does not apply, when the use of the standard method or its
equivalent methods is unchanged. However this rule does not hold, when the standard method
is combined and used for a new test objective.

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3.4 Documentation

Laboratories maintaining a flexible scope of accreditation must have, where it is applicable,

fully documented procedures for the validation of method modifications (incl. modifications of
parameters and matrices) and for the verification of additional methods to be covered under
the flexible accreditation scope. The appropriateness and robustness of these procedures will
be assessed by the Accreditation Body prior to accreditation being granted for a flexible scope.

Complete records of validation and verification of additional methods and the data obtained
must be retained and made available for review at assessment. This would normally be in the
form of a validation and/or verification report.

The laboratory must also retain a current list of methods for which it is accredited, including
those that are modified, newly introduced or developed.

3.5 Responsibilities

The responsible staff must regularly review the modified, revised or newly developed
methods, in order to ensure that they continue to meet specified or implied requirements.
Procedures and responsibilities relevant to the development or revision of methods covered by
accreditation must be reviewed periodically by the responsible management and take into
account the results of internal and external quality control. Records must be available for
review by the Accreditation Body.

4. SPECIFIC GUIDELINES FOR THE ON-SITE ASSESSMENT

4.1 General

Assessment activities may be grouped in two practical elements which inter-relate and whose
complexity and importance depend on the extent of the scope, namely:

- the assessment of the quality management system;

- assessment of technical competence.

With regard to the technical aspects, the assessment and the surveillance visits should cover all
the fields of activity mentioned in the scope over a full assessment cycle. For a given field of
activity, the Accreditation Body should ensure that it assesses the key methods in the scope
and the associated personnel, that it selects tests that can be witnessed during the assessment
and surveillance visits and that the selected methods are suitable to provide confidence in the
competence of the laboratory to perform all the tests and measurements proposed for the scope
of accreditation at an appropriate quality level.

Possible criteria for the selection of these methods, from both quantitative and qualitative
points of view, may be:

- evidence of the implementation of the quality management system, experience,

capability, if any, of modification/development of methods
- technical complexity
- consequence of errors (possible risks)
- balance between standard methods and nonstandard methods

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- balance between complete observations of performance and checks of reports and/or

validation records and/or quality control records and/or inspection of laboratory
facilities

During the initial assessment or reassessment the number of methods to be assessed must be
sufficiently large so that the key or principal methods in each field of activity can be drawn
upon and be adequately assessed. In each field of activity in any case, at least one key or
principal method must be assessed.

During every surveillance visit, methods that the laboratory has modified, newly introduced,
or developed since the last assessment visit must be explicitly assessed.

4.2 Flexible scope

When assessing flexible scopes of accreditation, the focus of the assessment of the
laboratorys management system should be on the implementation of the validation and/or
verification procedures required under 3.3 above, and the monitoring activities related to their
implementation e.g. review of requests, tenders and contracts, management review, internal
audits, personnel competence and authorities, measurement uncertainty estimations,
equipment and measurement traceability, proficiency testing activities and internal quality
control. Particular attention should also be given to the appropriateness of claims of
accreditation status with regard to previously un-assessed activities under the flexible scope of
accreditation.

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