2. ISO/IEC 17025 is the international
standard used by laboratories in
developing their quality,
administrative and technical systems
that govern their operations.
3. The two main clauses are:
o Clause No. 4.0 Management
Requirements
o Clause No. 5.0 Technical
Requirements
4. Legally Identifiable
Meet the needs of Client, ISO/IEC-
17025, regulatory authorities
Scope
• permanent facilities/mobile facility
• Sites away from permanent
facility/temporary facility
Defined Authority / Responsibility
• Part of large organization
• Key personnel :- potential conflict of
interest
• Nominated managers for Quality and
Technical Function
• Nominated deputies
Cont’d
5. Free from commercial , financial
pressure.
Clients confidential information,
proprietary rights.
Competence, Impartiality, judgment
and Integrity
Organization chart indicating
relationship between Quality Manager,
Technical operations and support
services
Inter-personnel relationship
6. Quality system documentation
shall be communicated to,
understood by , available to,
and implemented by the
appropriate personnel.
7. “a document stating the quality
policy and describing the
quality system of an
organization”
ISO 10013
9. - It is to ensure that each person
working in laboratory has with
him/her, the current version of
document, to perform his/her
work.
10. Review and approval of documents
Master List of procedure
• availability
• Review, revision & amendment
• Externally-generated Documents
• removal of obsolete documents
• identification of obsolete documents
retained for other reasons
Cont’d
11. Identification of Document
• Title
• date of issue
• revision status
• page numbering to signify end of
document
• authority for issue
12. The laboratory must have a format procedure
for the planned and systematic evaluation of
its capability to undertake each new request
to provide a testing or measuring service.
The procedure will also apply to undertaking
or accepting a significant increase in the
volume of testing work currently performed.
13. Approval from client, preferably in
writing, when the lab intends to
subcontract.
Ensure and demonstrate subcontractors
competence and compliance with 17025.
Laboratory maintains responsibility.
Maintain a register of all subcontracting
work.
14. Procedures for selection and purchasing of
service and supplies that affect the quality of
tests
Procedures for handling consumable
materials
Purchasing document contains description
Inspected or otherwise verified as complying
Record of evaluation of suppliers of critical
service
15. Clients allowed to clarify requirements
and monitor performance of laboratory.
Laboratory to ensure confidentiality to
other clients.
16. Policy and procedure for resolution of
complaints
Records of complaints, including all
investigations and corrective actions
17. Policy and procedures for nonconformance in
testing. Procedure shall include:
• responsibilities and authorities are
defined
• evaluation of significance
• remedial actions
• recall of nonconforming work released to
clients
• responsibility for resumption of work
18. Corrective actions focuses on fixing
problems that already exist.
Corrective action must be implemented
when departures from acceptable
practices are identified.
Cause analysis - root cause.
Eliminate the problem, prevent
recurrence.
Cont’d
20. Identify potential sources for
nonconformance, technical or relating to
quality system.
Procedures
• initiation of action , implementation
• controls to ensure effectiveness
21. Procedure for identification, collection,
indexing, access, storage, maintenance,
disposal of quality and technical records.
Records legible, readily retrievable,
stored in a suitable environment.
Secure and in confidence.
Protection and backup of computer
records.
22. Predetermined schedule.
Comply with requirements of Quality
System and ISO/IEC 17025.
All elements of Quality System.
Trained and qualified personnel,
independence & Conflict of Interest.
Records maintained of audits findings
and corrective actions.
23. Management with executive responsibility.
Predetermined schedule.
Suitability and effectiveness.
Changes for improvements.
Record the findings and also corrective actions.
Quality manager is responsible to prepare the
agenda.
Quality manager is responsible for action taking
as decided by Management Review.
25. Number required for workload
Qualifications and experience
Responsibilities and authorities
Job descriptions
Performance criteria and performance
appraisal
Training needs identification
Training records
Continuing education
26. Approved signatory status is granted to
those staff members of a laboratory who
are sufficiently qualified and experienced
and who have been assessed by AB to be
fully competent in technical and quality
management aspects of the laboratory.
27. Technical Competence including:
Relevant qualifications and/or experience.
Close involvement in the day-to-day operations.
Familiarity with test procedures including scientific basis
and technical limitations.
Ability to make critical evaluation of test results.
Knowledge of Quality Management system.
Knowledge of and commitment to AB and their criteria
and ISO/IEC 17025.
Sufficient time in the laboratory to become fully familiar
with the operating systems of the laboratory.
28. A laboratory is any place, in a building or in
the field where measurements, tests,
calibrations are carried out.
ISO/IEC 17025
“The laboratory facilities for testing and/or
calibration shall be such as to facilitate
correct performance of tests and/or
calibrations. The laboratory shall ensure
that the environment does not invalidate
the results or adversely affect the required
quality of any measurement.
29. The environment is the set of conditions that may
influence the test and/or measurement results.
Considerations :
• Temperature and humidity
• Dust, biological sterility,chemical cleanliness
• Ventilation and fume extraction
• Noise levels and acoustics and ergonomics
• Vibration and radiation
• Cross contamination prevention
• Power Supply and electromagnetic
compatibility
• Lighting
• People access and security issues
30. ISO/IEC 17025 :1999 - the laboratory shall have
instructions on the use of equipment, on the
handling, and preparation of items and for test
and calibration procedures and the calculation
of uncertainty of measurement.
Meets Clients requirements
Test methods from standard writing institution
Laboratory developed test methods
Non standard test methods
31. Consider:
Client’s wants and needs
Regulatory or standard requirements
Industry acceptance
Sampling and sample preparation
Environmental and accommodation requirements
Staff capability requirements
Repeatability, reproducibility and uncertainty
Recovery or matrix effects
Safety
Cost and time
32. Selectivity & specificity
Range
Linearity
Limit of detection
Limit of repeatability
Reproducibility
Ruggedness
Bias
Precision
33. ISO/IEC 17025 (5.4.6)
Calibration laboratory or testing laboratory
doing calibrations must formally estimate
uncertainty for all calibrations.
Testing laboratories must estimate
uncertainty but may be with less rigor:-
…..They must make a “reasonable estimation”
and “attempt to identify all components”.
34. Sufficient and appropriate for workload
Fit for purpose
Instillation, Environment
Commissioning and Verification
In-use status to prevent other staff
interfering
Maintenance schedules
Operational status - damaged?
Control and repair procedures
Calibrations and schedules
Records of all above items.
35. Property of the result of a measurement or
the value of a standard whereby it can be
related to stated references, usually ,
national or international standards , through
an unbroken chain of comparisons all having
stated uncertainties
NOTES
1. The concept is often expressed by the
adjective Traceable
2. The unbroken chain of comparisons is called
a Traceability chain.
36. INTERNATIONAL BUREAU OF WEIGHTS
AND MEASURES ( BIPM, PARIS)
NATIONAL METROLOGY
LABORATORY
(NML)
ACCREDITED LABORATORIES
USER TESTING/CALIBRATION LABORATOTRY
37. Reference Material accompanied by, a
certificate, one or more of whose property
value are certified by a procedure which
establishes its traceability to an accurate
realization of the unit in which the property
values are expressed and for which each
certified value is accompanied by an
uncertainty at a stated level of confidence.
ISO Guide 39 : 1992
38. Reference materials must be:
Characterized (certified value)
Homogeneous
Stable
Certified, traceable reference materials
purchased from reputable sources.
Certified traceable calibration standards
traceable to national or international measures.
Reference materials and items used for no other
purpose than calibration.
Check intermediate materials and items regularly
against reference standards.
Store reference items and materials carefully.
39. The sampling process may be one of the most critical
aspects of the entire testing procedure, and may be
a major contributor to the overall uncertainty of
measurement.
The laboratory must assure that the samples for
testing have been taken by a skilled person following
approved sampling procedures.
When laboratory is not directly responsible for
sampling or has no assurance that samples truly
representative of the bulk of product to be assessed,
the laboratory must protect itself thus:
Each test report shall carry a statement such as:
“Results relate only to the sample as received”
40. ISO/IEC 17025:1999 “the laboratory shall have
procedure to protect the integrity of
test/calibration items ”
Identify test/calibration items & sub- samples
throughout.
Record abnormalities of items & consult client for
advice.
Prevent deterioration during storage & handing –
monitor and record conditions.
Security during storage.
In non-destructive testing, prevent damage/injury
to samples/people.
Sampling plan & handling procedures available to
sampling staff.
41. Quality Control – Operational activities aimed at
monitoring the quality of testing throughout the
process and at identifying unsatisfactory results.
Checking calculations and data transcriptions
Blanks, standards, reference items, retest of
retained items
Replicate testing and statistical calculations
(confidence limits)
Trends analysis and trend charts
The laboratory Comparison Programmes
( Proficiency testing)
QUALITY CONTROL INCLUDES PROFICIENCY
TESTING
42. ILAC Guidance to Clause 5.10
(G.5.10.1)
G.5.10.1 laboratories that are accredited by
an accreditation body which is a signatory of
the ILAC or regional multilateral agreement in
the field of testing or calibration, may state
on certificates and reports, in the appropriate
language: xxxxx (full name or acronym of
accreditation body) is one of the signatories to
the yyyyy (full name or acronym of the
regional or international organization)
multilateral agreement / arrangement for the
mutual recognition of test reports and/or
calibration certificates (whichever is
relevant).
Cont’d.
43. ILAC Guidance to Clause 5.10.4.2. (G.5.10.4.2.1.)
G.5.10.4.2.1 accreditation bodies should provide rules
for the way in which measurement uncertainty has to
be taken into account when statements of compliance
are made. Such rules should follow ILAC G8 or EA5/01.
Clause 5.10.6 testing and calibration results obtained
from subcontractors.
ILAC Guidance to Clause 5.10.6. (G.5.10.6.1)
G.5.10.6.1 accreditation bodies should ensure that
when the laboratory does not take responsibility for
the subcontracted work, as provided for in ISO/IEC
17025 clause 4.5.3 this fact is clearly stated in the
report.
44. Laboratory clients want the solution to
their problem, not a list of numbers
Opinions and interpretations include
Opinions on conformity of samples/items with
requirements
Fulfillment of contractual requirements
Recommendation on how to use test results
Guidance on improvements
Special staff will be granted signatory
approval for opinions and interpretations.
They may have special technical
qualifications.
Knowledge and experience assessed by the
technical assessor.
Example: Medical Pathologists verses
Technologists
