EN ISO/IEC 17025
EN ISO/IEC 17025
“General requirements for the competence of testing
and calibration laboratories”
Dr. Wolfgang Garche
Saxony-Anhalt Environmental Protection Agency
Department Air Quality Monitoring, Information, Assessment
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
1
EN ISO/IEC 17025
 What means accreditation in accordance to EN ISO/IEC 17025
Confirmation of competence of a testing or calibration laboratory
by an independent third party, the accreditation body, to carry out
specific tests and/or calibrations.
Usually there are national regulations for one or several accreditation
bodies in each country.
The accreditation bodies cooperate in international organisations:
Europe:
European Accreditation Cooperation (EA)
Worldwide: International Laboratory Accreditation Cooperation
(ILAC)
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
2
EN ISO/IEC 17025
Scope of accreditation
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A laboratory may apply quality assurance procedures according to EN
ISO 17025 to all or a part of its operations.
Quality management is supported by a clear statement of activities,
 which ideally should define the range of work,
 without restricting the laboratory's operation.
The scope is typically defined in terms of:
 range of products, materials or sample types
 measurements (or types of measurements)
 specification or method/equipment/technique
 concentration range and uncertainty
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
3
EN ISO/IEC 17025
 Management requirements
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organisation
quality system
document control
review of requests, tenders and contracts
subcontracting of tests and calibrations
purchasing services and supplies
service to the client
complaints
control of nonconforming testing and /or calibration work
corrective action
preventive action
internal audits
management reviews
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
4
EN ISO/IEC 17025
 Technical requirements
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personnel
accommodation and environmental conditions
test and calibration methods and method validation
equipment
measurement traceability
sampling
complaints
handling of test calibration items
assuring the quality of test and calibration items
reporting the results
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
5
EN ISO/IEC 17025
Organisation
 legal responsibility
 meeting the requirements of this International Standard, satisfying the
needs of the client, the regulatory authorities or organisations providing
recognition
 The management system shall cover work carried out in all facilities:
- laboratory's permanent facilities,
- at sites away from its permanent facilities,
- or in associated temporary or mobile facilities
 Responsibilities of key personnel shall be defined in order to
identify
potential conflicts of interest
 managerial and technical personnel with the authority and resources
needed to carry out their duties
 specify the responsibility, authority and interrelationships of all personnel
who manage, perform or verify work affecting the quality of the tests
and/or calibrations
 technical management with overall responsibility for the technical
operations
 appoint a member of staff as quality manager
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
6
EN ISO/IEC 17025
Quality System
 Establishing, implementing and maintaining a quality system
appropriate to the scope of its activities.
 Documenting its policies, systems, programmes, procedures and
instructions to the extent necessary to assure the quality of the test
and/or calibration results.
 The system's documentation shall be communicated to, understood by,
available to, and implemented by the appropriate personnel.
 Quality manual
The laboratory's quality system policies and objectives shall be defined in a
quality manual (however named).
 Quality policy statement
The overall objectives shall be documented in a quality policy statement. The
quality policy statement shall be issued under the authority of the chief
executive.
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
7
EN ISO/IEC 17025
 Documentation
QMH
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description of organisation
quality policy statement
range of services, quality objectives, responsibilities
general statements that requirements of EN ISO 17025 are complied
• descriptions of the applied procedures for fulfilment of the
requirements of EN ISO 17025
• descriptions of special procedures used for specific operating
processes
Procedure
instructions
Standard Operation
Procedures (SOP‘s)
• detailed guidelines for the execution of single works
Forms, Lists, Control Charts
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
• formal templates and working tools for the
creation of test records and for the
documentation of measurements, tests, audits,
etc.
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
8
EN ISO/IEC 17025
Management Reviews
Laboratory's executive management shall periodically conduct a review about
the laboratory's quality system testing and/or calibration activities: ensure their
continuing suitability effectiveness, and to introduce necessary changes or
improvements
Review shall take into account:
the suitability of policies and procedures
reports from managerial and surveyor personnel
the outcome of recent internal audits
corrective and preventive actions
assessments by external bodies
the results of interlaboratory comparisons or proficiency tests
changes in the volume and type of the work
client feedback
complaints
other relevant factors, such as quality control activities, resources and
staff training
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
9
EN ISO/IEC 17025
Technical Requirements
 General
Factors which determine the correctness and reliability of the tests
and/or calibrations performed by a laboratory:
human factors
accommodation and environmental conditions
test and calibration methods and method validation
equipment)
measurement traceability
sampling
the handling of test and calibration items
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
10
EN ISO/IEC 17025
 Personnel
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Requirements for personnel:
Ensuring the competence of all who operate specific equipment,
perform tests and/or calibrations, evaluate results, and sign test
reports and calibration certificates.
Personnel certification: the laboratory is responsible for fulfilling
specified personnel certification requirements.
Training programme
Supervising additional personnel
Authorization
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
11
EN ISO/IEC 17025
 Accommodation and Environmental Conditions
 Laboratory facilities
 Monitoring the environmental conditions
Tests and calibrations shall be stopped when the environmental
conditions jeopardize the results of the tests and/or calibrations.
 Preventing cross-contamination
 Access to the laboratory
 Good housekeeping
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
12
EN ISO/IEC 17025
 Test and Calibration Methods and Method Validation
 Using appropriate methods and procedures for all tests and/or
calibrations within its scope.
 The laboratory shall have instructions on the use and operation of all
relevant equipment, and on the handling and preparation of items for
testing and/or calibration,
 shall be kept up to date and shall be available for the personnel
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Selection of methods
Laboratory developed methods
Non-standard methods
Validation of methods
Estimation of uncertainty of measurement
Control of data
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
13
EN ISO/IEC 17025
 Equipment
Records of Equipment shall include at least the following:
the identity of the item of equipment and its software
the manufacturer's name, type identification, and serial number or other
unique identification
checks that equipment complies with the specification
the current location, where appropriate
the manufacturer's instructions, if available, or reference to their location
dates, results and copies of reports and certificates of all calibrations,
adjustments, acceptance criteria, and the date of next calibration
the maintenance plan, where appropriate, and maintenance carried out to
date
any damage, malfunction, modification or repair to the equipment
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
14
EN ISO/IEC 17025
 Measurement Traceability
 The laboratory shall have an established programme and procedure for
the calibration of its equipment.
 Such a programme should include a system for selecting, using,
calibrating, checking, controlling and maintaining measurement
standards, reference materials used as measurement standards, and
measuring and test equipment used to perform tests and calibrations.
 Specific requirements
for calibration laboratories:
- traceable to the International System of Units (SI)
(Systeme international d'unites).
Testing
 Reference standards and reference materials
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
15
EN ISO/IEC 17025
 Further Requirements
 Sampling
 Handling of test and calibration items
 Assuring the quality of test and calibration results
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
16
EN ISO/IEC 17025
 Reporting the Results
Results shall be reported
 accurately,
 clearly,
 unambiguously
 objectively
 in accordance with any specific instructions in the test or
calibration methods.
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
17
EN ISO/IEC 17025
 Test Reports and Calibration Certificates
A test report or calibration certificate shall include at least the following
information:
 a title (e.g. "Test Report" or "Calibration Certificate")
 the name and address of the laboratory
 unique identification of the test report or calibration certificate (such as the serial
number),
 the name and address of the client
 identification of the method used
 a description of and unambiguous identification of the item(s) tested or calibrated
 the date of receipt of the test or calibration item(s) where this is critical to the
validity and application of the results, and the date(s) of performance of the test or
calibration
 the test or calibration results
 the name(s), function(s) and signature(s) or equivalent identification of person(s)
authorizing the test report or calibration certificate
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
18
EN ISO/IEC 17025
 Calibration Certificates
shall include:
the conditions (e.g. environmental) under which the calibrations were
made that have an influence an the measurement results
the uncertainty of measurement and/or a statement of compliance
with an identified metrological specification
evidence that the measurements are traceable
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
19
EN ISO/IEC 17025
Many Thanks for your Attention!
Saxony-Anhalt
State Environmental Protection Agency
Wolfgang Garche
EU Twinning RO 04/IB/EN/09
Bukarest 23.05.2007
20