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Accreditation or Certification For Laboratories
Accreditation or Certification For Laboratories
Accreditation or Certification For Laboratories
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
3
Specific Needs…
environmental studies
dangerous substances
4
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
6
Tools and Mechanisms
Standardization
Laboratory infrastructure
Quality management
Metrology
Accreditation
GLP
7
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
9
How can We be Sure
that…
10
Demands
Accreditation
Market
Product/
Consumer
Service
Legislation
Supplier
Requirements
Conformity Assessment
11
ISO/IEC Guide 2 and EN
45020
refer to definitions and
terminology of standardization
and related activities.
12
Following the Definitions…
Accreditation refers to
competence to carry out
specific tasks
Certification refers to
assurance of conformity to
specified requirements
13
Testing is Carried out…
by laboratories
in the private sector
in – house
second party
third party
in the public sector
competent authorities
14
We need to Measure!
15
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)
16
The Laboratory
Environment
Accreditation
Body Legislation
Calibration
Laboratories
Laboratories
LABORATORY
Certification
Body
-Suppliers
-Equipment
-Reagents, CRM’s
Clients
17
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
18
Laboratories’ Operation
is Based on…
Quality System
methodology
equipment (suitability, calibration,
maintenance, conditions)
personnel (competence)
determination of uncertainty
19
Basic Documents for
Laboratories
ISO 17025
EA Guidelines
ISO 9000
ISO 14000 (if applicable)
GLP (if applicable)
Legislation
20
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
21
Sources of Information
www.european-accreditation.org
www.eurachem.ul.pt
www.eurolab.org
www.ilac.org
www.irmm.jrc.be
22
Accreditation and
Certification
present both
similarities related to the audit-
23
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
24
However…
This is not enough and does
not fit the purpose!
25
We Need Something More!
We need tools for the assessment
of the technical competence of
laboratories to carry out specified
tasks
26
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?
27
Can Both Activities…
be used by laboratories to
document their competence and
the reliability of their results?
Do these two procedures represent
equivalent criteria?
28
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
29
Differences in the
Procedure
refer to the following issues
validation of test methods
expression of uncertainty
calibration of equipment
competence of personnel
30
What about Uncertainty?
How educated is the client to
consider properly and make
correct use of the expressed
uncertainty of measurement?
31
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!
32
Technical Competence of
Personnel Means…
Suitable academic qualifications
Adequate experience/training
Awareness and familiarisation
with particular methods and
techniques
33
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?
34
Who are the Customers?
competent authorities
industrial units
purchasers
individuals
other laboratories
35
ISO 9000 Provides…
for suppliers and sub-contractors
to be included in the approved list.
Relevant requirements are
specified in the Quality System.
36
The Most Usual
Requirement…
is ISO 9000 certification
this refers also to laboratories that
are listed as approved suppliers/
subcontractors
37
A Survey was Carried
out…
by ILAC in 1996 to evaluate the
competence of the laboratories,
the needs of their customers
and market trends.
38
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.
40
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
41
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.
42
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
43
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
45
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.
46
To Achieve Reliability…
a Laboratory needs to take some
basic steps, starting with the
preparation and implementation of
a Quality System.
47
Establishing Reliability…
Accreditation
•Reliability
•Competence of personnel
•Suitability of equipment
•Calibration of equipment
•Interlaboratory comparisons
•Method validation
Quality System
48
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
49
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
50
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.
51
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.
52
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.
53
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.
54
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.
55
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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