Pre-requisites for ISO 17025 Accreditaion

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Process of Obtaining UKAS Accreditation
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• CONTENTS
• Pre-Requisites for Laboratory Accreditation
• 2. The Process of Obtaining UKAS Accreditation
• The Advantages of being an Accredited Laboratory
• 4. Setting-up Costs
• 5. Recurring Costs
• 6. Additionally

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• 1 Pre-requisites (at a minimum) are
• A quality manual referenced to each section of
  ISO17025
• An environmentally controlled laboratory with
  secure access
• A designated Head of Laboratory responsible for
  its operation , and having a complete
  understanding of its measurement procedures , the
  operation of its test equipment , and of its
  quality management system (QMS)
• An appropriate range of reference standards each
  with a traceable calibration
• A suitable range of test and measuring equipment
• A series of operational procedures
• A series of calibration instructions
• Uncertainty calculations for all accredited
  calibrations or generic groups of calibration
• Applicable British , International , and GPS
  standards

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• 2 The Process of Obtaining Accreditation
• Decide what items you want to test or calibrate
• Make a formal application to UKAS using their
  Form AC3
• Establish the laboratory , its equipment , and
  traceability
• Formulate the Quality Management System (QMS)
• 5. Send copies of the quality manual and
  uncertainty calculations to UKAS
• 6. Undergo a Pre-Assessment visit by UKAS
• 7. Supply evidence to UKAS to discharge any
  actions/findings
• 8. Undergo the formal UKAS Assessment visit
• 9. Obtain Accreditation

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• 3 The Advantages of being an Accredited
  Laboratory
• 1. Industrial , National , and International
  recognition
• 2. Enhances the organisations reputation
• 3. Improved customer satisfaction and
  confidence
• 4. A business edge over non-accredited
  competitors
• 5. A source of additional revenue
• 6. Known and accepted methods , procedures
  and practices are in place
• 7. On-going monitoring via internal auditing
• 8. Can improve a customers measuring
  capability by him taking account of known errors
  in his own measuring systems
• 9. The scope for continual improvements that
  can be made

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• 4 The Initial Costs Involved
• Setting-up costs
• 1. Establishing the laboratory itself ,
  including temperature control , measuring
  equipment , and reference standards
• 2. UKAS charges for pre-assessment and
  assessment visits
• Assume 8000 to 12000 . A formal
  quotation will be supplied by UKAS upon your
  formal application
• 3. PKQA Services (or other consultancy)
• Office based writing/formulating the
  complete QMS 1500 .
• For site visits , travel and
  accommodation would be at cost , plus 240 per
  full day on site (120 per half day) .
• NOTE The QMS can be formulated by
  yourselves
• 4. Purchase of furnishings , fixtures and
  fittings
• 5. Staff (and their training)

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5 The Recurring Costs Approximate
budget for maintenance of Accreditation 1.
UKAS Assume 3000 to 6000 . A formal quotation
will be supplied by UKAS prior to their
visit 2. External calibrations for on-going
traceability 3. Annual service and
maintenance of test equipment 4. Consultancy
costs for Internal Audits PKQA Services can
quote if required 5. The costs for services
, supplies , materials , on-going training of
staff , etc
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• 6 Also available from PKQA Services
• 1. ISO 17025 A 50 slide detailed
  presentation itemising
• the requirements a laboratory needs to
  implement in order to comply with ISO 17025
• 2. Auditing the QMS A 25 slide
  presentation of the Internal auditing process for
  accredited laboratories
• 3. Remote management of your QMS
• 4. Internal auditing - requires 2 to 3 site
  visits annually , certain audits could be office
  based on your supply of the necessary
  documentation confidentiality is assured
• 5. Formulation/writing of the QMS , including
  procedures , instructions , quality manual and
  uncertainty calculations
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