ISOIEC 17025 Elements

1
ISO/IEC 17025 Elements

• By
• DEVI SARAN TEWARI

2
INTRODUCTION

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

3
ISO/IEC 17025

• The two main clauses are
• Clause No. 4.0 Management Requirements
• Clause No. 5.0 Technical Requirements

4
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

Contd
5
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

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Quality System (Cl. No. 4.2)

• Quality system documentation shall be
  communicated to ,understood by,available to, and
  implemented by the appropriate personnel.

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The Quality Manual (Cl. No. 4.2)

• a document stating the quality policy and
  describing the quality system of an organisation
• ISO 10013

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Structure of Documentation (Cl. No. 4.2)
Quality Manual
Quality Procedures
Instructions
Blank Tags, Forms, Labels, Cards, Worksheets
etc.
Data
9
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.

10
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

Contd
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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

12
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.

13
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.

14
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

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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.

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Complaints (Cl. No. 4.8)

• Policy and procedure for resolution of complaints
• Records of complaints, including all
  investigations and corrective actions

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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

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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.

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

21
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.

22
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.

23
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.

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ISO/IEC 17025 Standard

• Technical Requirements
• Clause No. 5.0

25
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

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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.

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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.

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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.

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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

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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

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Test Method Selection (Cl. No. 5.4)

• Consider
• Clients 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
Validation (Cl. No. 5.4)

• Selectivity specificity
• Range
• Linearity
• Limit of detection
• Limit of repeatability
• Reproducibility
• Ruggedness
• Bias
• Precision

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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.

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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.

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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
• The concept is often expressed by the adjective
  Traceable
• The unbroken chain of comparisons is called a
  Traceability chain.

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Path for Traceability of Measurement
INTERNATIONAL BUREAU OF WEIGHTS AND MEASURES (
BIPM, PARIS)
NATIONAL METROLOGY LABORATORY (NML)
ACCREDITED LABORATORIES
USER TESTING/CALIBRATION LABORATOTRY
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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
38
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

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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.

40
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

41
Handling of Test and Calibration Items (Cl. No.
5.8)

• ISO/IEC 170251999 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.

42
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

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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).

Contd..
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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.

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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
  Technologists

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Thanks