Accreditation or Certification for
Laboratories?
Kyriacos C. Tsimillis
Tsimillis, K.: Accreditation or Certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
In Today’s Society…
 some trends are of importance
 free movement of goods
 elimination of technical barriers to
trade
 broadening of quality concept
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Specific Needs…
 exist in some sectors
 food
 health care services
 environmental studies
 New Approach Directives
 dangerous substances
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
There is a Need to…
 create an international technical
language to ensure common
understanding!
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
As a Result…
 efficient tools and mechanisms are
required.
 Emphasis is given on their worldwide
implementation in a harmonised way
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Tools and Mechanisms






Standardization
Laboratory infrastructure
Quality management
Metrology
Accreditation
GLP
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Tools and Mechanisms (cont.)






Technical Notification
Environmental management
Modules/Notified Bodies
Harmonised Standards
Ecolabeling
Occupational health and safety
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
The Infrastructure Required…
 consists of
 Laboratories
 Standardization bodies
 Certification bodies
 Inspection bodies
 Accreditation bodies
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Demands
Accreditation
Certification
Body
Inspection
Body
Laboratory
Demands
Market
Product/
Service
Consumer
Legislation
Supplier
Requirements
Conformity Assessment
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
ISO/IEC Guide 2 and EN 45020
 refer to definitions and terminology
of standardization and related
activities.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Following the Definitions…
 Accreditation refers to competence
to carry out specific tasks
 Certification refers to assurance of
conformity to specified
requirements
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Testing is Carried out…
by laboratories
 in the private sector
 in – house
 second party
 third party
 in the public sector
 competent authorities
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
We need to Measure!
 If you cannot measure something
 it doesn't exist!
 Therefore we need
 methodology
 equipment
 personnel
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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)
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
The Laboratory Environment
Accreditation
Body
Legislation
Calibration
Laboratories
Laboratories
LABORATORY
Certification
Body
-Suppliers
-Equipment
-Reagents, CRM’s
Clients
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Laboratories’ Operation
is Based on…






Quality System
methodology
equipment (suitability, calibration,
maintenance, conditions)
personnel (competence)
determination of uncertainty
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Basic Documents for
Laboratories






ISO 17025
EA Guidelines
ISO 9000
ISO 14000 (if applicable)
GLP (if applicable)
Legislation
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
To Avoid any Hidden Barriers…
 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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Sources of Information





www.european-accreditation.org
www.eurachem.ul.pt
www.eurolab.org
www.ilac.org
www.irmm.jrc.be
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
However…
This is not enough and does not
fit the purpose!
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
We Need Something More!
 We need tools for the assessment of
the technical competence of
laboratories to carry out specified tasks
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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?
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Can Both Activities…
 be used by laboratories to document
their competence and the reliability of
their results?
 Do these two procedures represent
equivalent criteria?
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Differences in the Procedure
refer to the following issues
 validation of test methods
 expression of uncertainty
 calibration of equipment
 competence of personnel
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
What about Uncertainty?
 How educated is the client to consider
properly and make correct use of the
expressed uncertainty of measurement?
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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!
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Technical Competence of
Personnel Means…
 Suitable academic qualifications
 Adequate experience/training
 Awareness and familiarisation with
particular methods and techniques
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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?
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Who are the Customers?





competent authorities
industrial units
purchasers
individuals
other laboratories
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
ISO 9000 Provides…
 for suppliers and sub-contractors to be
included in the approved list.
 Relevant requirements are specified in
the Quality System.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
The Most Usual Requirement…
 is ISO 9000 certification
 this refers also to laboratories that are
listed as approved suppliers/
subcontractors
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
A Survey was Carried out…
by ILAC in 1996 to evaluate the
competence of the laboratories, the
needs of their customers and market
trends.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Therefore the Two Standards…
 can easily be correlated and provide the
basis for comparison of the two
procedures they refer to
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
To Achieve Reliability…
 a Laboratory needs to take some
basic steps, starting with the
preparation and implementation of
a Quality System.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
Establishing Reliability…
Accreditation






Reliability
Competence of personnel
Suitability of equipment
Calibration of equipment
Interlaboratory comparisons
Method validation
Quality System
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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.
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching
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
Tsimillis, K.: Accreditation or certification for Laboratories?
© Springer-Verlag Berlin Heidelberg 2003
In: Wenclawiak, Koch, Hadjicostas (eds.)
Quality Assurance in Analytical Chemistry – Training and Teaching