Why Use ISOIEC 17025

1
Why Use ISO/IEC 17025?

• ISO/IEC 17025 sets out requirements that give
  confidence in the calibrations and tests
  performed by laboratories.

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Structure of ISO/IEC 17025

• Clause 4 Management Principles
• Clause 5 Requirements for Technical
  Competence

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4.1 Organization

• Legally responsible
• Meet standard, Client, Regulatory Accreditation
  Bodies Requirements
• Permanent and site based work
• Other activities/responsibilities influencing lab
  work defined

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4.1 Organization (Contd)

• Authority and resources
• Freedom from undue pressure
• Policies and procedures for protection of
  confidentiality
• Policies and procedures to protect competence,
  impartiality, integrity
• Organizational structure and place in parent
  organization
• Responsibilities, authorities and
  interrelationships of personnel
• Adequate supervision
• Technical Management
• Quality Manager
• Deputies for key managerial personnel

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4.2 Quality System

• Established, implemented and maintained
• Policy statement authorized by Chief Executive
• Commitment to good practice and Client service
• Standard of service
• Objectives
• Familiarity, Understanding and Implementation
• Commitment to ISO 17025
• Quality Manual
• Policies and objectives
• Reference Procedures
• Duties of Technical and Quality Managers

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4.3 Document Control

• 4.3.1 General
• Procedure to control internal/external documents
• Review and approval
• Master list or equivalent
• 4.3.2 Document Approval and Issue
• Authorized docs available at point of use
• Retained obsolete documents identified
• Unique identification (date/rev, page/end doc)
• 4.3.3 Document Changes
• Changes reviewed by authorized personnel
• Identification of Changes
• Handwritten amendments
• Procedure for changes to electronic documents

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4.4 Review of Requests, Tenders Contracts

• Procedures for contract review
• Requirements defined, documented and understood
• Capability and resources
• Appropriate methods selected
• Differences between tender and contract
• Subcontracted Work
• Records of reviews, significant changes and
  discussions with client
• Notification of client deviations
• Review of changes to contract and communication
  of changes

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4.5 Subcontracting of Test and Calibrations

• Subcontracting of work
• Unforeseen circumstance
• Continuing basis
• Competent subcontractor
• Advise client in writing
• Laboratory responsible for subcontractors work
  unless otherwise specified
• Register and records of compliance

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4.6 Purchasing Services Supplies

• Policy and procedures
• Selection of services and supplies
• Purchase, reception and storage of
  reagents/consumables
• Verification of supplies and reagents
• Prior to use
• Compliance with requirements
• Records
• Purchasing data
• Evaluation of suppliers
• Record of evaluation
• Listing of approved suppliers

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4.7 Service To The Client

• Co-operation to clarify clients request
• Monitoring of Laboratorys performance
• Confidentiality
• May include
• Reasonable access for witness
• Preparation, packaging and dispatch of items
• Communication process
• Client Surveys

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4.8 Complaints

• Policy and procedure for complaint resolution
• Records
• Complaints
• Investigations
• Corrective Action

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4.9 Control of Non-conforming Calibration Work

• Examples
• Complaints, audits, reviews and QC checks
• Calibration/maintenance/test results
• Incoming material checks
• Staff observations/documentation checks
• Policy/Procedures for deviations
• Responsibilities defined
• Evaluation of significance
• Remedial action
• Notification of client where necessary
• Authorize resumption of work
• Corrective action

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4.10 Corrective Action

• Policy and procedure
• Root Cause Analysis
• Selection and implementation of corrective
  actions
• Appropriate to risk/magnitude
• Document and implement changes
• Monitoring or corrective actions
• Additional audits

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4.11 Preventative Action

• Identification of improvements
• Pro-active vs. Reactive
• Action plan
• Implementation
• Monitoring
• Procedures to ensure effectiveness

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4.12 Control of Records

• Procedures for system/technical records
• Legibility/retention times
• Security and confidentiality
• Electronic data
• Original and derived data
• Sufficient for repetition
• Identity of responsible personnel
• Recorded at time made/traceable to task
• Handling of mistakes

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4.13 Internal Audits

• Periodic, scheduled audits
• Address all elements
• Controlled by Quality Manager
• Training/qualification of auditors
• Timely corrective action
• Client notification if doubt raised
• Records
• Follow-up

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4.14 Management Reviews

• Scheduled reviews
• Suitability of policies/procedures
• Management reports
• Internal audits
• Corrective/preventative actions
• External assessments
• Interlaboratory comparisons
• Workload and type of work
• Client feedback
• Complaints
• QC checks, resources, training
• Timely action
• Records of reviews and follow-up

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5.1 General

• Results influenced by
• Human factors
• Accommodation/environmental conditions
• Test/calibration methods validation
• Equipment
• Measurement traceability
• Sampling
• Handling of items
• These factors should be taken into account by the
  laboratory

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5.2 Personnel

• Competence of Personnel
• Supervision of unqualified staff
• Qualification/authorization of personnel
• Establishment of qualification goals
• Identification of training needs
• Use of contracted staff
• Job descriptions
• Records

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5.3 Accommodation Environmental Conditions

• Suitable facilities/conditions
• Monitor and record relevant conditions
• Separation of incompatible activities
• Controlled access
• Good housekeeping

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5.4 Test Calibration Methods Method Validation

• Use of appropriate methods
• Up-to-date operating instructions
• Availability of methods/instructions
• Justification of deviations
• Selection of methods
• National/International standards
• Reputable technical organizations
• Validated laboratory developed methods
• Client notified of method/appropriateness
• Re-confirmation if method changed

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5.4 Test Calibration Methods Method
Validation (Contd)

• Laboratory-developed methods
• Planned activity updated during development
  process
• Assignment of qualified personnel
• Adequate resources
• Communication
• Non-standard methods
• Agreement with client
• Clear specification of requirements
• Validation prior to use

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5.4 Test Calibration Methods Method
Validation (Contd)

• New methods to address
• Identification
• Scope
• Description of item
• Parameters/ranges
• Apparatus/equipment and technical performance
  requirements
• Reference standards/materials
• Environmental conditions/stabilization
• Description of procedure
• Accept/reject criteria
• Data to be recorded
• Uncertainty

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5.4 Test Calibration Methods Method
Validation (Contd)

• Validation is the confirmation by examination and
  provision of objective evidence that the
  particular requirements for a specific use are
  fulfilled
• Non-standard methods
• Laboratory developed methods
• Standard methods used outside intended scope
• Amplifications/modifications to standard methods
• Validation may be performed by
• Use of reference standards/materials
• Comparison of results with other methods
• Inter-laboratory comparisons
• Assessment of factors influencing results
• Assessment of uncertainties

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ISO 17025 Measurement Uncertainty Requirements

• Procedure for estimation of uncertainty for
  calibration activities
• Uncertainty in testing to be estimated whenever
  possible
• All uncertainty components to taken into account

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5.4 Control Of Data

• Checking of calculations and data transfers
• Use of computers/automated equipment
• Software sufficiently documented/validated
• Protection of data
• Proper maintenance

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5.5 Equipment

• Equipment available and capable
• Control of equipment used outside laboratory
• Calibration program
• Verification/calibration prior to use
• Operation by authorized personnel
• Availability of equipment manuals
• Identification of equipment/software

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5.5 Equipment (Contd)

• Equipment records
• Identity of equipment and software
• Manufacturer name, type, serial no.
• Checks made on equipment
• Location (where appropriate)
• Manufacturers instructions/location
• Full history of calibration/maintenance and due
  dates
• Damage/repair/modifications

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5.5 Equipment (Contd)

• Procedures for handling/storage/maintenance
• Suspect or defective equipment identified/removed
  and effect on previous work assessed
• Calibration status (last cal/next due)
• Checks on equipment going outside of labs control
• Procedures for in-service checks
• Control of correction factors
• Safeguarding of equipment/software

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5.6 Measurement Traceability

• Calibration of equipment prior to use
• Program and procedure for calibration
• Traceability
• To SI units
• Unbroken chain of calibrations
• Competence of calibration facilities
• If traceability is not possible, use consensus
  standards or interlaboratory comparisons
• May be waived by testing laboratories if it can
  be demonstrated that the contribution to
  uncertainty is negligible

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5.6 Reference Standards/materials

• Reference standards
• Procedures for calibration
• Calibration performed by competent laboratory
• Used for calibration only unless it can be
  demonstrated that unaffected by use
• Calibrated before/after adjustment
• Procedures for intermediate checks
• Proper handling, transport and storage

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5.7 Sampling

• Statistically valid sampling plansif used
• Client requested deviations from sampling plans
  communicated
• Records
• Data
• Procedure used
• Identification of sampler and where relevant,
• Environmental conditions
• Details of sampling location
• Statistical basis

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5.8 Handling Of Calibration Items Test Items

• Procedures for transportation, receipt, handling,
  protection, storage, retention and/or disposal
• Identification of items throughout
• On receipt
• Recording of abnormalities
• Consultation with client if doubt
• Facilities for protection/security

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5.9 Assuring The Quality Of Test And Calibration
Results

• Procedures for monitoring validity of
  tests/calibrations and trends
• Inter-laboratory comparisons/PT
• Replicate testing/calibration
• Correlation of results

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5.10 Reporting the Results

• Clear, accurate, unambiguous, objective
• Opinions and interpretation
• Results from subcontractors
• Electronic transmission of results
• Format of reports
• Amendments to reports
• Content of all reports (5.10.2)
• Test reports (5.10.3) Not applicable to AFPSL
• Calibration certificates (5.10.4)

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5.10.2 Calibration Test Reports

• Title
• Name and address of lab
• Location of test/cal
• Unique identification of report
• Page and end of report identification
• Name and address of client
• Identification of method used
• Condition of item
• Date of receipt/performance
• Reference to sampling procedure
• Results and units
• Name, function and signature
• Statement results apply only to items
  tested/cald

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5.10.3 Test Reports

• Not Applicable to the AFPSL

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5.10.4 Calibration Certificates

• Calibration certificates
• Environmental conditions
• Uncertainty of measurement
• Evidence of traceability
• Results to relate only to quantities and
  functional tests
• Where statements of compliance made, uncertainty
  to taken into account
• It item adjusted/repaired, before/after
  calibration results reported
• No recommendation on next due date (unless
  client/legal requirement)