Accreditation or

Certification for
Laboratories?

Kyriacos C. Tsimillis

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In Today’s Society…
 some trends are of importance
 free movement of goods
 elimination of technical barriers

to trade
 broadening of quality concept

2
Quality Issues are…

 nowadays considered to be of
highest importance as a result of
increasing awareness of existing
needs.
 This is illustrated in
 legislative requirements and
 high competition on quality aspects

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Specific Needs…

 exist in some sectors

 food
 health care services

 environmental studies

 New Approach Directives

 dangerous substances

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There is a Need to…
 create an international technical
language to ensure common
understanding!

5
As a Result…
 efficient tools and mechanisms are
required.
 Emphasis is given on their
worldwide implementation in a
harmonised way

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 Tools and Mechanisms
 Standardization
 Laboratory infrastructure
 Quality management
 Metrology
 Accreditation
 GLP

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 Tools and Mechanisms
(cont.)
 Technical Notification
 Environmental management
 Modules/Notified Bodies
 Harmonised Standards
 Ecolabeling
 Occupational health and safety

8
The Infrastructure
Required…
 consists of
 Laboratories
 Standardization bodies

 Certification bodies

 Inspection bodies

 Accreditation bodies

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How can We be Sure
that…

 products and services meet the

specifications?
 By “conformity assessment”, i.e.
checking that products and
services meet the relevant
standard´s specifications.

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 Demands
Accreditation

Certification Inspection Laboratory Demands

Body Body

Market

Product/
Consumer
Service
Legislation

Supplier
Requirements

Conformity Assessment

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ISO/IEC Guide 2 and EN
45020
 refer to definitions and
terminology of standardization
and related activities.

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Following the Definitions…

 Accreditation refers to
competence to carry out
specific tasks
 Certification refers to

assurance of conformity to
specified requirements

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Testing is Carried out…
by laboratories
 in the private sector

 in – house
 second party
 third party
 in the public sector
 competent authorities

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We need to Measure!
 

 If you cannot measure something

 it doesn't exist!
 Therefore we need
 methodology
 equipment
 personnel

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The Role of Laboratories
 drafting of standards
 development of new methods
 implementation of standards,
technical regulations and the
legislation
 provision of services (testing,
calibration, consultancy)

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 The Laboratory
Environment
Accreditation
Body Legislation

Calibration
Laboratories

Laboratories
LABORATORY

Certification
Body
-Suppliers
-Equipment
-Reagents, CRM’s
Clients

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Laboratories Need…
 to demonstrate their technical
competence and reliability
 to this end they need also to have
policies how to estimate the
uncertainty of their measurements

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Laboratories’ Operation
is Based on…
 Quality System
 methodology
 equipment (suitability, calibration,
 maintenance, conditions)
 personnel (competence)
 determination of uncertainty

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Basic Documents for
Laboratories
 ISO 17025
 EA Guidelines
 ISO 9000
 ISO 14000 (if applicable)
 GLP (if applicable)
 Legislation

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 to the free movement of goods,
services and personnel, conformity
assessment activities should be
homogeneous and be implemented
according to relevant Guides of
ISO/IEC and EA Guidelines

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Sources of Information
 www.european-accreditation.org
 www.eurachem.ul.pt
 www.eurolab.org
 www.ilac.org
 www.irmm.jrc.be

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Accreditation and
Certification
present both
 similarities related to the audit-

based nature of the procedures

and
 differences with regard to the

tasks and the resulting procedure

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They are Both Related to…
 quality assurance policies
 considered of high importance
tools
 in today’s society with regard to
the free movement of goods

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However…
This is not enough and does
not fit the purpose!

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We Need Something More!
 We need tools for the assessment
of the technical competence of
laboratories to carry out specified
tasks

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Is there any Confusion…
 on the use of these two
procedures, their significance and
their role within conformity
assessment activities?
 If so, why does this happen?

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Can Both Activities…
 be used by laboratories to
document their competence and
the reliability of their results?
 Do these two procedures represent
equivalent criteria?

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Main Differences Refer
to…
 the objective and content
 the documentation
 assessors’ competence
 procedure of assessment
 the use of the logo
 how wide the scope is

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Differences in the
Procedure
refer to the following issues
 validation of test methods

 expression of uncertainty

 calibration of equipment

 competence of personnel

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What about Uncertainty?
 How educated is the client to
consider properly and make
correct use of the expressed
uncertainty of measurement?

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The Meaning of
Uncertainty
 is not well understood by the
clients.
 They may not choose a laboratory
which produces results that are
“uncertain” to some extent!

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Technical Competence of
Personnel Means…
 Suitable academic qualifications
 Adequate experience/training
 Awareness and familiarisation
with particular methods and
techniques

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Quality Means…
 meeting the customers’ needs.
 How clear are these needs for the
customers and how are they
expressed in the communication
with the laboratories?

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Who are the Customers?
 competent authorities
 industrial units
 purchasers
 individuals
 other laboratories

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ISO 9000 Provides…
 for suppliers and sub-contractors
to be included in the approved list.
 Relevant requirements are
specified in the Quality System.

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The Most Usual
Requirement…
 is ISO 9000 certification
 this refers also to laboratories that
are listed as approved suppliers/
subcontractors

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A Survey was Carried
out…
by ILAC in 1996 to evaluate the
competence of the laboratories,
the needs of their customers
and market trends.

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According to the Survey…
 a small percentage of laboratories
are certified
 big laboratories use accreditation
for ISO 9000 compliance
 accreditation is preferred to
certification to demonstrate
technical competence

39
Suggestions were Made …
 for the revision of ISO/IEC Guide 25
and EN 45001 and harmonization
with ISO 9000 on management
issues
 this would facilitate the promotion
of mutual recognition of this part
of the system.

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The Standard ISO 17025
 has replaced the former European
standard EN 45001 to ensure a
worldwide acceptance of a unique
document for the assessment of
laboratories under accreditation

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1999 Edition of the
Standard
 provides for a clarification of the
situation
 it classifies the main requirements
in two main categories,
 the Management Issues and
 the Technical Competence Issues.

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The Structure of the
Standard…
 enables a direct correlation with
ISO 9000:1994.
 ISO 17025 specifies management
requirements and technical
requirements in separate chapters.
 The former corresponds to ISO
9000 requirements

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Therefore the Two
Standards…
 can easily be correlated and
provide the basis for comparison of
the two procedures they refer to

44
The Standard ISO
9000:2000
 is a new version of the previously
existing ISO 9000 series.
 This fact doesn’t alter the findings
of the correlation made above

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It is Expected that…
 in this way an agreement for
mutual recognition could be
established thus enabling
laboratories to avoid duplication in
work and additional costs.

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To Achieve Reliability…
 a Laboratory needs to take some
basic steps, starting with the
preparation and implementation of
a Quality System.

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Establishing Reliability…
Accreditation

•Reliability
•Competence of personnel
•Suitability of equipment
•Calibration of equipment
•Interlaboratory comparisons
•Method validation

Quality System

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When Taking the First
Step…
 the Laboratory should prepare and
implement a Quality System as
described by either ISO 9000 or
ISO 17025.
 This step does not impose the
need for certification

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Further to a Quality
System….
We need to ensure factors
contributing to the reliability of the
Laboratory
 Technical competence of personnel
 Adequacy of infrastructure
 Fitness of methodology

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The Scope of Accreditation
 usually includes only few of the
methods carried out in the
laboratory.
 These methods are the ones for
which technical competence is
assessed.
 The Quality System covers the
overall activity.
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Laboratories Operating in
 certified industrial units have to
meet the relevant requirements of
ISO 9000
 therefore they may find it easier to
go on towards accreditation.

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However, in Such a Case…
 one more requirement should be
considered, i.e. the one referring to
the documentation of the
independence of the laboratory
from the parent company.

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It should be Clear that…
 if the need refers only to
compliance with quality
management issues, certification
may be considered adequate
 accreditation may also be
considered as equivalent with
respect to these issues.

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It should also be Clear
that…
 if the need refers to the technical
competence, accreditation of the
laboratory with a detailed
description of its scope is the
appropriate means to demonstrate
it.

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There is Still
 much more work to be carried out
towards a better understanding
and harmonisation of the
approaches with regard to
laboratory work and the use of test
and calibration results

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