ISO 17025

ISO/IEC 17025 ElementsISO/IEC 17025 Elements
ByBy
AKMA LIZAAKMA LIZA

INTRODUCTION
 ISO/IEC 17025 is the international standard
used by laboratories in developing their
quality, administrative and technical systems
that govern their operations.

ISO/IEC 17025
 The two main clauses are:
o Clause No. 4.0 Management Requirements
o Clause No. 5.0 Technical Requirements

Organization (Cl. No. 4.1)
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

Organization (Cl. No. 4.1)
 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

Quality System (Cl. No. 4.2)
 Quality system documentation shall be
communicated to ,understood by,available to,
and implemented by the appropriate personnel.

The Quality Manual (Cl. No. 4.2)
“a document stating the quality policy and
describing the quality system of an
organisation”
ISO 10013

Structure of Documentation
(Cl. No. 4.2)
Quality
Manual
Quality
Procedures
Instructions
Blank Tags, Forms, Labels,
Cards, Worksheets etc.
Data

Document Control
(Cl. No. 4.3)
- It is to ensure that each person
working in laboratory has with
him/her, the current version of
document, to perform his/her work.

Documentation Control
(Cl. No. 4.3)
 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

Documentation Control
(Cl. No. 4.3)
 Identification of Document
• Title
• date of issue
• revision status
• page numbering to signify end of
document
• authority for issue

Review of Requests, Tenders
and Contracts (Cl. No. 4.4)
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.

Subcontracting of tests or
calibrations
(Cl. No. 4.5)
 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.

Purchasing Services and
Supplies
(Cl. No. 4.6)
 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

Service to the client
(Cl. No. 4.7)
 Clients allowed to clarify requirements and
monitor performance of laboratory.
 Laboratory to ensure confidentiality to other
clients.

Complaints
(Cl. No. 4.8)
 Policy and procedure for resolution of
complaints
 Records of complaints, including all
investigations and corrective actions

Control of Non-Conforming Testing
and/or Calibration Work (Cl. No. 4.9)
 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

Corrective Action
(Cl. No. 4.10)
 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

Corrective Action Loop
(Cl. No. 4.10)Problem
Identified
Records &
Document
Updated
Corrective
Action
Affective?
Likely
Cause
Identified
Corrective
Action
Identified
Corrective
Action Taken
No
Yes

Preventive Action
(Cl. No. 4.11)
 Identify potential sources for nonconformance,
technical or relating to quality system.
 Procedures
• initiation of action , implementation
• controls to ensure effectiveness

Records
(Cl. No. 4.12)
 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.

Internal Audits
(Cl. No. 4.13)
 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.

Management Review
(Cl. No. 4.14)
 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.

ISO/IEC 17025 Standard
Technical Requirements
Clause No. 5.0

The “People” Requirements of
Accreditation (Cl. No. 5.2)
 Number required for workload
 Qualifications and experience
 Responsibilities and authorities
 Job descriptions
 Performance criteria and performance appraisal
 Training needs identification
 Training records
 Continuing education

Approved Signatories
 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.

Criteria for the granting of
“Approved Signatory” status
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.

Accommodation and Environment
(Cl. No. 5.3)
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.

Laboratory Environment (Cl. No. 5.3)
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

Test & Calibration Methods
(Cl. No. 5.4)
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

Test Method Selection (Cl. No. 5.4)
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

Validation (Cl. No. 5.4)
 Selectivity & specificity
 Range
 Linearity
 Limit of detection
 Limit of repeatability
 Reproducibility
 Ruggedness
 Bias
 Precision

Measurement Uncertainty
(Cl. No. 5.4)
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”.

Equipment (Cl. No. 5.5)
 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.

Traceability (Cl. No. 5.6)
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.

Path for Traceability of Measurement
INTERNATIONAL BUREAU OF WEIGHTS
AND MEASURES ( BIPM, PARIS)
NATIONAL METROLOGY
LABORATORY
(NML)
ACCREDITED LABORATORIES
USER TESTING/CALIBRATION LABORATOTRY

Voltage Traceability
JOSEPHSON VOLT
UNCERTAINTY +/- 0.001 ppm
ELECTRONIC STANDARD CELL
+/- 0.5 ppm
HIGH ACCURACY CALIBRATOR
+/- 1 ppm
MEDIUM ACCURACY CALIBRATOR
+/- 50 ppm
HAND HELD VOLTMETER
+/- 1000 ppm or 0.1 %

Certified Reference Material (CRM)
(Cl. No. 5.6)
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

Reference Material (Cl. No. 5.6)
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.

Sampling (Cl. No. 5.7)
 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”

Handling of Test and Calibration Items
(Cl. No. 5.8)
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.

Quality Control (Cl. No. 5.9)
 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

Reporting the Results (Cl. No. 5.10)
 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.

Reporting the Results (Cl. No. 5.10)
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.

Opinions and Interpretations
(Cl. No. 5.10)
 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

ISO 17025

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