EUROPEAN UNION WATER INITIATIVE PLUS

FOR THE EASTERN PARTNERSHIP

Support of Water Policy Reforms towards Integrated Water Resources Management

Workshop on laboratory basics and

fundamentals of ISO Certification
ISO 17025 – technical
requirements
Cristina Trimbacher
Section 5
Technical Requirements
 Many factors determine the correctness and
reliability of tests performed by a lab contributing
from:
• Human factors
• Accommodation & environmental condition
• Test & calibration methods and method validation
• Equipment
• Measurement traceability
• Sampling
• Handling of test and calibration items
Technical Requirements
Management Technical
requirements requirements
4.1 Organisation
4.2. Management System 5.1 General
4.3. Document control 5.2 Personnel
4.4. Review of requests, tenders & contracts 5.3 Accommodation & environmental
4.5. Subcontracting conditions
4.6. Purchasing services & supplies 5.4. Test methods & method validation
4.7. Service to the customer 5.5. Equipment
4.8. Complaints
4.9.Control of nonconforming work 5.6. Measurement traceability
4.10. Improvement 5.7. Sampling
4.11. Corrective action 5.8. Handling of test items
4.12. Preventive action 5.9. Assuring the quality of tests
4.13. Control of records 5.10. Reporting of results
4.14. internal audits
4.15. Management review
Personnel

 Competence
• appropriate education, training, experience, skills, knowledge of
the tests carried out, etc.
 Training programme
 current job descriptions
• For managerial, technical and key support personnel
• Responsibilities and duties in all steps of test, qualification
requirements
Accommodation and
environmental conditions
 Suitable lab facilities
 Conditions have to be monitored and documented,
where they influence the result
• e.g., temperature , humidity,…
 Separation of areas with incompatible activities
• Prevention of cross-contamination
• e.g., separation of sample preparation and analysis, separation of
storing samples and reference material
 Controlled access
 Good housekeeping
5.3 environmental conditions

 Labs have to ensure

• Environmental conditions do not invalidate or adversely
affect the required quality
• Particular care required for sampling
• Documentation of adverse conditions
5.3 environmental conditions

 Labs have to ensure

• Attention has to be paid to: dust, biological sterility,
electromagnetic disturbances, radiation, humidity,
electrical supply, temperature, noise, vibrations as
appropriate to the technical activities concerned
• Otherwise tests have to be stopped and conditions re-
established!
5.3 environmental conditions

 Dust
• About 5000 chemicals can be encountered in
household dust – exposure of equipment ?
 Biological sterility
• Where necessary – mould?
 Electromagnetic disturbances
• Susceptibility of instruments to electromagnetic
fields
5.3 environmental conditions

 Radiation
• UV, gamma radiation
 Humidity
• Appropriate humidity for instruments
 Electric supply
• 230/380V – UPS/power fluctuation
5.3 environmental conditions

 Temperature
• Exhaust of GC ovens, pumps etc – Head Space?
 Noise
• Occupational safety – continuous noise
 Vibrations
• Sensitive parts – hard disks or balances!
5.3 environmental conditions

 Effective separation between antagonising activities

• VOC measurement – solvent extraction
 Spatial separation, sufficient and effective exhausts
• A priori – experience and reaction to effects
 Phthalates – identification of sources of blanks
• Control of areas affecting the quality of tests
 dust generation (milling room), corrosive vapours
digestion ,…
• Assurance of good housekeeping
 Documentation of cleaning
 Use of detergents with adverse properties?
Validation

Validation is the confirmation by

examination and the provision of objective
evidence that the particular requirements
for a specific intended use are fulfilled.
Test methods and method validation

 appropriate methods and procedures for all tests

within its scope
• Sampling, handling, transport, storage, preparation of items to be
tested/calibrated, measurement uncertainty
• Instructions, standards, manuals and data shall be up to date and
be available to personnel
 methods published in international, national or
regional standards shall preferably be used
• All methods shall be validated
• in-house validation
Test methods and method validation

 procedures for non-standard methods (SOP)

• appropriate identification
• scope
• description of the type of item
• parameters or quantities and ranges to be determined
• apparatus and equipment
• reference standards and reference material
• environmental conditions required
• description of the procedure
• data to be recorded
• uncertainty of the procedure
Test methods and method validation

 description of the procedure has to include

• Checks before start of work

• Equipment checks, calibration, adjustment if required
• The method of recording results and observations
• Safety measures
Equipment

Equipment and its software used for testing, calibration

and sampling
 unique identification !
• records of each item of equipment
identity
manufacturer’s name, type, serial number
current location
manufacturer’s instructions
reports of all calibrations, adjustments, ...
maintenance plan
damage, malfunction, modification, repair
Equipment Inventory
(Example)
Equipment
 Accommodation
• Appropriate accommodation is required by the standard ISO/IEC 17025
– otherwise accreditation is impossible
• ISO/IEC 17025 requires valuable items in terms of accommodation
which have to be met
• It encourages us to extend itself according to our experience (quality
improvement)
 Equipment
• Equipment has to meet our quality specifications (more is appreciated,
but not required)
• Maintenance of equipment is required to maintain and improve quality
standards
• Equipment has to be placed where it can be used properly without
being affected and affecting other procedures
Measurement Traceability
 Traceability refers to an unbroken chain of
measurements relating an instrument's measurement
to a known standard
 Traceability of measurements made by the laboratory
to the International System of Units (SI) has to be
ensured
 All equipment used for tests and subsidiary
measurements (e.g. for environmental conditions)
that have a significant effect on the validity of results
shall be calibrated before use !
Measurement Traceability, how ?

 Reference standards
• programme and procedure for the calibration of its reference
standards
• Calibration by a body that can provide traceability (e.g., National
Metrological Institute, accredited calibration labs)
• only use for calibration !

 Types of reference standards

• Physical Standards – such as reference weights and reference
thermometers
• Chemical Standards – such as standard solutions
• Biological Standards – such as culture collection microorganisms
Measurement Traceability, how ?

 Reference materials
• shall be traceable to SI units or be certified reference materials
 Intermediate checks
• to maintain confidence in the calibration status of reference,
primary, transfer or working standards
 Transport and storage
• procedure for save handling, transport, storage and use of
reference standards and reference materials to prevent
contamination
Sampling

 Sampling plan and procedure if sampling is carried out

by the lab
• plan and procedure shall be available on-site
• Sampling plan based on statistical methods where reasonable
 Why? The quality of the sampling and the selection of
representative samples affect the test results !
 Proper recording of relevant data for subsequent
analysis
 Appropriate sampling devices for subsequent analysis;
not always plastic bottles are ideal!!
Handling of Test Items

 Procedure for transportation, receipt, handling,

protection, storage, retention and/or disposal
• Including provisions to protect integrity of sample
 System for identifying samples
• Lab coding to be retained on samples all times to ensure that items
cannot be physically confused !
 Upon receipt check for any departures/defects of
sample and record it;
 If samples are sent/brought in, relevant info for
transport and storage need to be provided before
Assuring Quality of Test Results

 Quality control procedures for monitoring the validity

of tests
 Planned and reviewed monitoring including e.g.:
• Regular use of CRMs and/or internal quality control using
secondary reference materials;
• Participation in inter laboratory comparisons an proficiency testing
schemes;
• Replicate tests with the same or different method;
• Retesting of retained samples;
 Analysis of quality control data when they are outside pre-
defined criteria & corrective action
 EASTERN PARTNERSHIP (EaP) COUNTRIES:

ARMENIA AZERBAIJAN BELARUS GEORGIA MOLDOVA UKRAINE

EU MEMBER STATES AND EUROPEAN COMMISSION:

AUSTRIA FRANCE

INTERNATIONAL ORGANISATIONS: