ISO/IEC 17043:2010 pdf free.Conformity assessment — General requirements for proficiency testing.
ISO/IEC 17043:2010 specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. These requirements are intended to be general for all types of proficiency testing schemes, and they can be used as a basis for specific technical requirements for particular fields of application.
ISO/IEC 17043 has been prepared to provide a consistent basis for all interested parties to determine the competence of organizations that provide proficiency testing. In doing so it replaces both parts of ISOIIEC Guide 43:1997. ISO/IEC Guide 43 included not only guidance on development and operation of proficiency testing and selection and use of proficiency testing by laboratory accreditation bodies, but also useful descriptions of typical types of proficiency testing. This International Standard has preserved and updated the principles for the operation of proficiency testing described in ISO/IEC Guide 43 and has retained in Annexes A to C information on typical types of proficiency testing schemes, guidance on appropriate statistical methods, selection and use of proficiency testing schemes by laboratories, accreditation bodies, regulatory bodies, and other interested parties.
2 Normative references
ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles.
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and associated terms (VIM).
4 Technical Requirements
4.1 General
The development and operation of proficiency testing schemes shall be undertaken by proficiency testing providers having competence to conduct interlaboratory comparisons and access to expertise with the particular type of proficiency test items. Proficiency testing providers or their subcontractors shall also have competence in the measurement of the properties being determined.
NOTE ISO/IEC 17025 or ISO 15189 can be used to demonstrate the competence of a proficiency testing provider’s laboratory, or the laboratory subcontracted to perform tests or measurements related to the proficiency testing schemes. ISO Guide 34 can be used to demonstrate the competence of producers of reference materials that provide proficiency test items.
4.2 Personnel
4.2.1 The proficiency testing provider shall have managerial and technical personnel with the necessary authority, resources and technical competence required to perform their duties.
4.2.2 The proficiency testing provider’s management shall define the minimum levels of qualification and experience necessary for the key positions within its organization and ensure those qualifications are met.
4.2.5 The proficiency testing provider shall maintain up-to-date records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily avai’able and shall include the date on which competence to perform their assigned tasks was assessed and confirmed.
4.2.6 The proficiency testing provider shall formulate the objectives with respect to the education, training, and skills for each staff member involved with the operation of the proficiency testing scheme. The proficiency testing provider shall have a policy and procedures for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated needs of the proficiency testing provider.
NOTE It is advisable to consider the need to retrain staff periodically. Staff training policies can take account of technological change, the need to demonstrate ongoing competence and aim at continual skills upgrading.
4.2.7 The proficiency testing provider shall ensure that staff receive the necessary training to ensure competent performance of measurements, operation of equipment and any other activities which affect the quality of the proficiency testing scheme. The effectiveness of training activities shall be evaluated.
NOTE Objective measures can be used to assess the attainment of competence.