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. Issues. Short introduction of SWEDAC Accreditation procedure Accreditation requirements according to EN ISO/IEC 17025 (Flexible scope (or not))

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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

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

Swedish Board of Accreditation and Conformity Assessment

SWEDAC


Issues

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

Peter Askolin, SWEDAC


Swedac board of accreditation and conformity assessment

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

Peter Askolin, SWEDAC


En iso iec 17025 first edition 1999 12 15

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

General requirements for the competence of testing and calibration laboratories


En iso iec 17025

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§)

Peter Askolin, SWEDAC


4 management requirements

§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)

Peter Askolin, SWEDAC


4 management requirements1

§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

Peter Askolin, SWEDAC


Technical management

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

Peter Askolin, SWEDAC


Contract reviews

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.

Peter Askolin, SWEDAC


Subcontracting

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

Peter Askolin, SWEDAC


Internal audits

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

Peter Askolin, SWEDAC


Management review

Management review

  • Shall be done periodically by the laboratory management

  • To ensure quality improvements, suitability and introduce necessary changes.

  • Shall be documented

Peter Askolin, SWEDAC


Corrective actions

Corrective actions

  • Shall include cause analysis

  • Selection and implementation of corrective action

  • Shall be monitored

  • Additional audits

Peter Askolin, SWEDAC


Preventive actions

Preventive actions

  • Routines to identify needs to improvement

  • Identify potential sources of non-conformances

Peter Askolin, SWEDAC


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

Technical requirements

Peter Askolin, SWEDAC


Choosing methods

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

Peter Askolin, SWEDAC


Validation of methods

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.

Peter Askolin, SWEDAC


Uncertainty

Uncertainty

  • Laboratory has to

    • Identify potential components in uncertainty

    • Make an estimation of the uncertainty

    • Ensure that the result doesn’t give wrong impression

    • Based on knowledge, validation, experience

Peter Askolin, SWEDAC


Personnel

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)

Peter Askolin, SWEDAC


Opinions and interpretations

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

Peter Askolin, SWEDAC


Sampling

Sampling

  • Can be accredited separately

  • The laboratory cant automatically exclude sampling

  • Will be assessed if the laboratory performs such activities even if not accredited

Peter Askolin, SWEDAC


Control of data

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

Peter Askolin, SWEDAC


Accreditation procedure

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

Peter Askolin, SWEDAC


Flexible scope

Flexible scope

  • What is a flexible scope?

  • Requirements on the laboratory

  • Restrictions

  • Example of a flexible scope accredited by SWEDAC

Peter Askolin, SWEDAC


What s this

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

Peter Askolin, SWEDAC


Requirements

Requirements

  • Experience

  • Great technical competence

  • Personnel pointed out to do validations and development of methods

Peter Askolin, SWEDAC


Restrictions

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

Peter Askolin, SWEDAC


Accredited laboratories

SWEDAC

70 Clinical laboratories

32 Transfusion medicine

34 Clinical microbiology

8 Clinical pharmacology

5Clinical physiology

5Clinical pathology

1Hospital 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

Accredited laboratories

Peter Askolin, SWEDAC


Thank you

Thank you

Peter Askolin, SWEDAC


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