Peter Askolin, M. Sc. (Chemistry) Lead assessor at Division of Chemistry

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Peter Askolin, M. Sc. (Chemistry)Lead assessor
at Division of Chemistry

• Swedish Board of Accreditation and Conformity
  Assessment
• SWEDAC

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Issues

• Short introduction of SWEDAC
• Accreditation procedure
• Accreditation requirements according to EN
  ISO/IEC 17025
• (Flexible scope (or not))
• Statistics about medical laboratories accredited
  by SWEDAC and DANAK

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SWEDACBoard of Accreditation and Conformity
Assessment

• Placed under the Foreign Department
• Handles all Technical Control in Sweden
• Divided in 3 divisions that are handling
  accreditation of laboratories.
• General technology
• Chemistry
• Medical Technology and Electrotechnics

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EN ISO/IEC 17025First edition 1999-12-15

• General requirements for the competence of
  testing and calibration laboratories

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EN ISO/IEC 17025

• Replaces EN 45001
• International ISO standard
• A general standard not only for accreditation use
• Divided into 2 parts
• Management requirements (4)
• Technical requirements (5)

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4 Management requirements

• Incorporates ISO 9001 and 2 requirements
• Big efforts is made to guarantee the independency
  of the laboratory.
• Potential conflicts in interests shall be
  identified (e.g. the laboratory is placed
  directly under production)
• Personnel and management shall be free from
  financial, commercial and other pressures
  (external)

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4 Management requirements

• Technical management
• Quality system
• Contracting reviews
• Subcontracting tests to other laboratories
• Internal audit and Management review
• Corrective actions and preventive actions
• Control of records

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Technical management

• Technical leader shall be pointed out and
  deputie(s) for him.
• Has the overall responsibility of laboratory
  operations.
• Leads the laboratory work so that the required
  quality is reached.
• Technical competence

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Contract reviews

• Confirmation that both the laboratory and its
  customer have understood the commissioned work in
  the same manner
• Confirmation that the laboratory has necessary
  competence and resources for the commissioned
  work
• Shall include work that is subcontracted to other
  laboratories.

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Subcontracting

• Accreditation can only be granted for work that
  the laboratory usually performs itself.
• Shall be reported and approved by the customer
• Shall clearly be marked out.
• The laboratory shall make sure that the
  subcontractor works according to the std.
• The laboratory have overall responsibility

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Internal audits

• Shall be performed regularly
• Shall include all activities and elements
• Shall be carried out by trained and qualified
  personnel
• Independent from the activity being audited

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Management review

• Shall be done periodically by the laboratory
  management
• To ensure quality improvements, suitability and
  introduce necessary changes.
• Shall be documented

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Corrective actions

• Shall include cause analysis
• Selection and implementation of corrective action
• Shall be monitored
• Additional audits

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Preventive actions

• Routines to identify needs to improvement
• Identify potential sources of non-conformances

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Technical requirements

• Personnel
• Choosing methods
• Standard
• Modified standards, sector approved methods
• Own methods
• Example of an accreditation scope
• Validation of non standard methods
• Sampling
• Opinions and interpretations

• Measurement uncertainty
• Traceability
• Reference materials
• Control of data

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Choosing methods

• Standard methods
• Only verification needed
• Modified standard methods
• Verification
• Validation of modification needed
• Methods developed by the laboratory
• Full validation needed for all matrices
• Documentation

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Validation of methods

• Required
• Does not need to be preformed by the laboratory
  that uses the method
• All documentation shall be found at the
  laboratory
• The laboratory has to verify the competence and
  recourses that developed the method.
• SWEDAC has a document (informative) that helps
  chemical laboratories in validation.

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Uncertainty

• Laboratory has to
• Identify potential components in uncertainty
• Make an estimation of the uncertainty
• Ensure that the result doesnt give wrong
  impression
• Based on knowledge, validation, experience

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Personnel

• Can be employed or contracted
• Supervision in introduction
• Basic competency for accredited activities
• Job descriptions shall be maintained for all
  personnel (e.g responsibly for validation)

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Opinions and interpretations

• Shall be based on the results
• It must be clearly identified
• Procedures
• Technical competence
• The big responsibility for opinions and
  interpretations
• Not to be mixed with specifications

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Sampling

• Can be accredited separately
• The laboratory cant automatically exclude
  sampling
• Will be assessed if the laboratory performs such
  activities even if not accredited

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Control of data

• Control of datasets (e.g. Excel datasheets)
• Regularly controlled and when changed
• Documented (traceability)
• Validation of software developed by the
  laboratory.
• Electronic signatures (traceablility)
• Assessed by computer experts if necessary

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Accreditation Procedure

• Application from the laboratory
• The lead assessor from AB chooses the assessment
  team according to the scope
• Documentation will be assessed
• Visit to confirm compliance
• Laboratory fixes non-compliances
• Decision made by the AB

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Flexible scope

• What is a flexible scope?
• Requirements on the laboratory
• Restrictions
• Example of a flexible scope accredited by SWEDAC

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What's this?

• The laboratory can change the scope without
  asking permission from AB
• The changes will be audited on the yearly audit
  visit at the laboratory
• Freedom with great responsibility
• Certain limitations

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Requirements

• Experience
• Great technical competence
• Personnel pointed out to do validations and
  development of methods

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Restrictions

• Restricted to methods that are already used in
  the laboratory.
• Laboratory has to have experience in the method
  used and its limitations
• New methods cant be added to the scope
• New methodology cant be introduced

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Accredited laboratories

• SWEDAC
• 70 Clinical laboratories
• 32 Transfusion medicine
• 34 Clinical microbiology
• 8 Clinical pharmacology
• 5 Clinical physiology
• 5 Clinical pathology
• 1 Hospital physics

• DANAK
• Total of 17 accreditation's in laboratory
  medicine
• 8 of them at Statens Serum institute
• 2 Clinical biochemistry
• 1 Private in Clinical biochemistry and
  physiology
• 3 Veterinary laboratories
• 1 Forensic genetics

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Thank you