ISO 17025 and SANAS guidelines for use of reference materials and PT scheme participation Shadrack Phophi The Innovation Hub, Pretoria
Presentation layout 1. Introduction ISO/IEC 17025 2. Requirements for use Reference Materials / Certified Reference Materials 3. Requirements for use of Proficiency Testing 4. Challenges facing testing laboratories
What is ISO/IEC 17025? ISO/IEC 17025 contains the criteria necessary for a laboratory to implement in order for it to perform its test work competently The criteria that a laboratory must comply with to be internationally acceptable is ISO/IEC 17025.
ISO/IEC 17025 1. These are the base requirements necessary for a laboratory to be able to implement and operate to demonstrate it is competent They are not super requirements Cost (of compliance and/or Accreditation) is cost of achieving consistently good results Cost of not having consistently good results could be much higher 2. 17025 focus is on: Management requirements and Technical requirements Annex A Cross reference to ISO 9001 Annex B Guidelines for establishing application for sector fields
ISO/IEC 17025:2005
Requirements for use of Reference / Certified Reference Materials Definitions: Reference Material: Material or substance one or more whose property values are sufficiently homogeneous and well established to be used for calibration of an apparatus, assessment of a method, or assigning values to materials Certified Reference Material: Reference material accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes traceability to an accurate realization to 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
Requirements for use of Reference / Certified Reference Materials uncertainty C o m p a r i s o n s SI Units (Inter)national (Primary) Standards Secondary Standards In-house Standards Measurement / Calibration
Requirements for use of Reference / Certified Reference Materials ISO/IEC 17025 Clause 5.6.3.2 Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials. Note: Values associated with Reference Materials may not be metrological traceable. Values associated with certified Reference Materials are metrological traceable.
Requirements for use of Reference Materials ISO/IEC 17025 Clause 5.9 The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The monitoring shall be planned and reviewed and may include : a) Regular use of certified reference materials and/or internal control using secondary reference materials
Uses of Reference Materials / Certified Reference Materials The use of Reference materials / Certifies Reference Materials in quality assurance testing helps to ensure that the data generated by a particular testing lab is: a) Consistent b) High Quality c) Reliable d) Traceable NB: They are also used to evaluate the performance of laboratories and laboratory personnel through proficiency testing (PT).
Uses of Reference Materials / Certified Reference Materials The use of Reference materials / Certifies Reference Materials in quality assurance testing helps to ensure that the data generated by a particular testing lab is: a) Consistent b) High Quality c) Reliable d) Traceable NB: They are also used to evaluate the performance of laboratories and laboratory personnel through proficiency testing (PT).
Requirements for Proficiency Testing Definitions: Proficiency testing (PT): is the evaluation of participant performance against pre-established criteria by means of interlaboratory comparison (ISO/IEC 17043). Interlaboratory Comparison (ILC): is the organizations performance and evaluation of measurements or tests on the same or similar items by two or more laboratories predetermined conditions (ISO/IEC 17043).. in accordance with
Requirements for Proficiency Testing Clause 5.9 The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. include: The monitoring shall be planned and reviewed and may a) participation in interlaboratory comparison or proficiency- testing programmes
Requirements for Proficiency Testing The minimum PT activity according to a laboratory s scope is: i. Evidence of satisfactory participation prior to gaining accreditation where PT is available and appropriate ii. Further and ongoing activity that is appropriate to the scope of accreditation and consistent with the PT participation plan.
Requirement for Proficiency Testing ISO/IEC 17011 [7] requires accreditation bodies to take into account during assessment and the decision making process participation and performance in proficiency testing SANAS R80: All applicant testing laboratories are required to participate in appropriate proficiency testing or interlaboratory comparisons for the scope of accreditation required and provide SANAS with the relevant proof on application of participation and satisfactory performance.
Proficiency Testing SANAS R80: Where nor formal PT is practicable or available, the laboratory shall indicate suitable alternative means by which performance will be assessed and monitored. This may include activities such as intra-laboratory comparison, the use of reference materials or other comparisons. SANAS shall consider these alternative arrangements as part of the laboratory s planned activities. The onus is on the laboratory to provide the details of the plan and its justification thereof and obtain approval from SANAS.
Challenges faced by testing laboratories Unavailability of some reference materials for some tests then the lab starts using an assumed to be positive sample. Usually difficult to get hold of or to import them e.g. toxicants and certain zoonotic pathogens No Certificate of analysis therefore wrong ATCC strains of reference materials are used. Maintenance/verification of reference material Certain PT schemes only address a partial identification of some of the bacteria Financial constraints
Questions Thank You shadrackp@sanas.co.za