ISO/IEC 17025 :2017

1 06 Jan 18. ISO/IEC 17025 : 2017 (EN). GENERAL REQUIREMENTS FOR THE COMPETENCE OF. testing AND CALIBRATION LABORATORIES. Ajchara Charoensook ISO/IEC 17025 : 2017 . Table of contents Foreword Introduction 6 Resource requirements 1 Scope General 2 Normative references Personnel 3 Terms and definitions Facilities and environmental conditions 4 General requirements Equipment Impartiality Metrological traceability Confidentiality Externally provided products and 5 Structural requirements services Ajchara Charoensook 1. 06 Jan 18. ISO/IEC 17025 : 2017 . 7 Process requirements 8 Management system requirements Review of requests, tenders and contracts Options Selection, verification and validation of methods Management system documentation (Option A). Sampling Control of management system documents (Option A).

2 Control of records (Option A). Handling of test or calibration items Actions to address risks and opportunities (Option A). Technical records Improvement (Option A). Evaluation of measurement uncertainty Corrective actions (Option A). Ensuring the validity of results Internal audits (Option A). Reporting of results Management reviews (Option A). Complaints Annex A Metrological traceability Nonconforming work Annex B Management system options Control of data and information management Bibliography Ajchara Charoensook ISO/IEC 17025 : 2017 . The main changes the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;. there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities.

3 A definition of laboratory has been added in definition. Ajchara Charoensook 2. 06 Jan 18. ISO/IEC 17025 : 2017 . In this document, the following verbal forms are used: shall indicates a requirement;. should indicates a recommendation;. may indicates a permission;. can indicates a possibility or a capability. Ajchara Charoensook WHAT IS RISK-BASED THINKING? The concept of risk has always been implicit in ISO 9001 the 2015 revision makes it more explicit and builds it into the whole management system Risk-based thinking is already part of the process approach. Risk-based thinking makes preventive action part of the routine. Risk is often thought of only in the negative sense . Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk.

4 Ajchara Charoensook 3. 06 Jan 18. 1. SCOPE. This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories. Ajchara Charoensook 2 NORMATIVE REFERENCES. The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

5 ISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)1. ISO/IEC 17000, Conformity assessment Vocabulary and general principles Ajchara Charoensook 4. 06 Jan 18. 3 TERMS AND DEFINITIONS. For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at IEC Electropedia: available at Ajchara Charoensook 3 TERMS AND DEFINITIONS. impartiality presence of objectivity Note 1 Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory ( ).

6 Note 2 Other terms that are useful in conveying the element of impartiality include freedom from conflict of interests , freedom from bias , lack of prejudice , neutrality , fairness , open-mindedness , even-handedness , detachment , balance . Ajchara Charoensook 5. 06 Jan 18. 3 TERMS AND DEFINITIONS. complaint expression of dissatisfaction by any person or organization to a laboratory ( ), relating to the activities or results of that laboratory, where a response is expected interlaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions intralaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items within the same laboratory ( ) in accordance with predetermined conditions Ajchara Charoensook 3 TERMS AND DEFINITIONS.

7 Proficiency testing Evaluation of participants performance against pre-established criteria by means of interlabolatory comparison. Laboratory Body that performs one or more of the following activities;. - testing - calibration - sampling associated with subsequent testing or calibration Ajchara Charoensook 6. 06 Jan 18. 3 TERMS AND DEFINITIONS. decision rule rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement verification provision of objective evidence that a given item fulfils specified requirements validation verification ( ), where the specified requirements are adequate for an intended use Ajchara Charoensook RISK MANAGEMENT. Requires the laboratory to plan and implement actions to address risks and opportunities.

8 Establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed Ajchara Charoensook 7. 06 Jan 18. WHAT SHOULD WE DO ? 1. Identify what the risks and opportunities are in your organization 2. Plan actions to address the risks - how can I avoid or eliminate the risk? - how can I mitigate the risk ? 3. Implement the plan take action 4. Check the effectiveness of the actions does it work? Ajchara Charoensook IMPARTIALITY ( ). In order to safeguard impartiality - Establish structure - Mitigate pressures Identify & manage risks (ongoing basis). Risks may come from . - its activities - its relationship - the relationship of its personnel Demonstrate how to minimize or eliminate Risks Ajchara Charoensook 8.

9 06 Jan 18. CONFIDENTIALITY ( ). Legally enforceable commitment for management of information obtained or created during the performance of laboratory activities. Inform customer of if public exposure of information Third party communication requirement Ajchara Charoensook STRUCTURAL REQUIREMENTS (5). Legal entity Laboratory activities can be ;. Identify management Permanent facilities At sites away from its permanent Define and document the facilities laboratory activities Temporary Meet the requirements of Mobile facilities ISO/IEC 17025 : 2017 . Customer's facility. Customers Regulatory authorities and organizations providing recognitions Ajchara Charoensook 9. 06 Jan 18. STRUCTURAL REQUIREMENTS (5). Define organization and management Have personnel with authority and structure and relationships between resources needed to carry out laboratory management , technical operations and activities including: implementation, support services; maintenance,improvement, identification of deviations , initiation of actions to prevent or Specify responsibility ,authority and minimize deviations ,reporting to interrelationship of all personnel who management on the performance of manage , perform or verify works.

10 Document its procedures to ensure management system . consistency of works and validity of the results. Ajchara Charoensook STRUCTURAL REQUIREMENTS (5). Ensuring . the effectiveness of laboratory activities. Communication take place regarding the effective of the management system and the importance of meeting customers and other requirements;. Integrity of management system is maintained when changed to the management system are planned and implemented. Ajchara Charoensook 10. 06 Jan 18. RESOURCE REQUIREMENTS (6). Availability of personnel, facilities, equipment, systems and support services. ( ). Personnel ( ). Act impartially, be competent and work in accordance with lab's management system Evidences of the competence requirements (education, qualification, training, technical knowledge ,skills and experience).