tsimillis, k.: accreditation or certification for laboratories?© springer-verlag berlin heidelberg...
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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 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
Accreditation
Product/Service
Supplier
ConsumerLegislation
Inspection Body
LaboratoryCertification Body
Demands
Market
Conformity Assessment
Requirements
Demands
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
Accreditation Body
-Suppliers-Equipment-Reagents, CRM’s
Legislation
Laboratories
Calibration Laboratories
LABORATORY
Certification Body
Clients
The Laboratory Environment
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’ Operationis 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 ofa 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
ReliabilityCompetence of personnelSuitability of equipmentCalibration of equipmentInterlaboratory comparisonsMethod 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