ISO/IEC 17025 - PJCINC
ISO/IEC 17025Testing and Calibration LaboratoriesAN EXECUTIVE OVERVIEWPERRY JOHNSONPCJ C O N S U L T I N G , I N C .www.pjcinc.com 1-888-248-0256
ISO/IEC 17025:2017Testing and Calibration LaboratoriesAN EXECUTIVE OVERVIEWRevised 7/18PERRY JOHNSON CONSULTING, INC.Detroit200 East Big Beaver Rd. Troy, Michigan 480831-888-248-0256 or (248) 519-2602Website: www.pjcinc.com Email: pjc@pjcinc.com Copyright 2018 by PERRY JOHNSON CONSULTING, INC.All rights reserved. No part of this book may be reproduced in any form or by anymeans without permission, in writing, from Perry Johnson Consulting, Inc.
ISO/IEC 17025:2017Testing and Calibration LaboratoriesAn Executive OverviewCONTENTSForeword .3The Users of This Guide .4What is ISO/IEC 17025:2017? .5ISO/IEC Guide 25, ISO 9001:2015 and EN 45001 .5ISO/IEC 17025:2017 .6ISO/IEC 17025:2017-ISO 9001:2015 Comparison Chart .7ISO/IEC 17025:2017 Accreditation .9Key Steps to Achieving Accreditation .9What to Look For in an Accreditation Body .12What to Look For in an Auditor .12The Benefits of ISO/IEC 17025:2017 .13ISO/IEC 17025:2017 Requirements .14456General Requirements .144.1 Impartiality.144.2 Confidentiality .14Structural Requirements .15Resource Requirements .166.1 General .166.2 Personnel .166.3 Facilities and Environmental Conditions .166.4 Equipment .176.5 Metrological Traceability.196.6 Externally Provided Products and Services .20ISO/IEC 17025:2017 Executive OverviewPage 17/18
78Process Requirements .217.1 Review of Requests, Tenders and Contracts.217.2 Selection, verification and validation of methods.227.3 Sampling .247.4 Handling of Test or Calibration Items .247.5 Technical Records .257.6 Evaluation of Measurement Uncertainty .257.7 Ensuring the Validity of Results .267.8 Reporting of Results .277.9 Complaints .307.10 Nonconforming Work .317.11 Control of Data and Information Management .31Management System Requirements .338.1 Options .338.2 Management System Documentation (Option A).338.3 Control of Management System Documents (Option A) .348.4 Control of Records (Option A) .348.5 Actions to Address Risks and Opportunities (Option A).348.6 Improvement (Option A) .358.7 Corrective Action (Option A) .358.8 Internal Audits (Option A) .368.9 Management Reviews (Option A) .36Conclusion .38ISO/IEC 17025:2017 Executive OverviewPage 27/18
FOREWORDISO/IEC 17025:2017, General Requirements for the Competence of Testing and CalibrationLaboratories, released in 2017, contains all the requirements that testing and calibrationlaboratories must meet to demonstrate that they operate a quality management system, aretechnically competent and can generate technically valid results.This ISO/IEC 17025:1999 initial release of the standard replaced ISO/IEC Guide 25 and theEuropean Union’s EN 45001. ISO/IEC 17025 goes beyond both of these standards by addingnew requirements, along with significant changes to previous requirements. The 2017 version ofthe standard was released in November of 2017 to better align the standard with the requirementsof ISO 9001:2015. While many management system elements of ISO/IEC 17025:2017 mirrorthose of ISO 9001, the international quality management system standards, its additionaltechnical competency requirements are unique for testing and calibration laboratories.ISO/IEC 17025:2017 is the international basis for accrediting calibration and testing laboratories.It applies to both freestanding laboratories, as well as laboratories which are part of a largerfacility. When a laboratory is part of a larger facility, ISO/IEC 17025:2017 accreditation can beachieved simultaneously with ISO 9001:2015 or IATF 16949 registration, if the auditor isworking for both an accreditation body and a registrar.Calibration and testing laboratories accredited to ISO/IEC 17025:2017 will find internationalacceptance of their testing and calibration results, efficiency in their operations and improvedcustomer satisfaction.The effects of ISO/IEC 17025 management system and competency requirements are alreadybeing felt by thousands of laboratories around the world, with greater influence in the nearfuture. While implementing a management system is time-consuming and sometimes difficult,accredited laboratories will be considered to have higher standards and better quality results.This guide was created to aid those calibration and testing laboratories that are about to embarkupon the ISO/IEC 17025:2017 journey. It will help smooth out the bumps as it explains thegeneral requirements of ISO/IEC 17025:2017 step by step. Since achieving ISO/IEC 17025:2017accreditation is a lengthy and detailed process, it is strongly suggested that laboratories seekingaccreditation retain the services of a reputable consulting firm.PERRY JOHNSON CONSULTING, INC.July 2018ISO/IEC 17025:2017 Executive OverviewPage 37/18
THE USERS OF THIS GUIDEThis guide will be useful to managers and other personnel in organizations that meet any of thefollowing criteria: Independent testing laboratories Independent calibration laboratories Testing laboratories housed in corporate facilities Calibration laboratories housed in corporate facilities Automotive suppliers required to use accredited calibration and testing laboratories underIATF 16949 Firms wishing to do business with accredited testing and calibration laboratories Any other party with an interest in calibration and testing laboratory quality and competenceISO/IEC 17025:2017 accreditation provides calibration and testing laboratories with a significantcompetitive edge.ISO/IEC 17025:2017 Executive OverviewPage 47/18
WHAT IS ISO/IEC 17025:2017?ISO/IEC 17025:1999, General Requirements for the Competence of Testing and CalibrationLaboratories, released in 1999, is the international standard for establishing calibration andtesting laboratory quality management systems and recognizing laboratory technical competencethrough accreditation. ISO/IEC 17025:2017 was released in November 2017 to provide betteralignment to the requirements of ISO 9001:2015.This standard was drafted by the International Organization for Standardization (ISO)Committee on Conformity Assessment (CASCO) Working Group (WG) 10, and replacedISO/IEC Guide 25, General Requirements for the Competence of Calibration and TestingLaboratories, and EN 45001, General Criteria for the Operation of Testing Laboratories.All ISO 9001:2015 requirements that are relevant to the scope of testing and calibrationlaboratory quality management systems (QMS) have been incorporated into ISO/IEC17025:2017, along with technical competency requirements.The release of ISO/IEC 17025:2017 is the latest stage in the process of developing laboratoryquality and competence standards, which has been going on for more than 20 years. Let’s take abrief look at the history of this process.ISO/IEC Guide 25, ISO 9001:2015 and EN 45001The process began with the development of ISO/IEC Guide 25 by ISO and the InternationalElectrotechnical Commission (IEC). ISO, founded in 1946, is a federation of 132 nationalstandards bodies. IEC, founded in 1906, is a federation of 50 national electrical and electronicengineering standards committees. The American National Standards Institute (ANSI) is themember body and national committee representing the United States in both organizations.Under a formal agreement, ISO and IEC, both based in Geneva, Switzerland, form thespecialized system for worldwide standardization and operate joint technical committees, withIEC safeguarding electrotechnical interests in matters of international standardization not relatedto any particular technology. These international standards are designed to facilitate world tradeby removing technical barriers.ISO/IEC Guide 25 was first released in 1978 and underwent minor revisions in 1982. These firsttwo editions were primarily focused on requirements for assessing the technical competence oftesting laboratories.In 1987, the ISO 9000 international quality management system standards were issued, sparkinga greatly increased focus on management systems. This event had a major influence onlaboratory standard developments.ISO/IEC 17025:2017 Executive OverviewPage 57/18
The first such standard to be influenced by ISO 9000 was EN 45001, issued in 1989 by theEuropean Union (EU), which consists of 15 member states: Austria, Belgium, Denmark, Finland,France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Swedenand the United Kingdom. The EU comprises a marketplace of some 370 million people. EN45001 focused on competence and operation, including the management system, of testing andcalibration laboratories.Further developments in the laboratory quality approach were incorporated in the 1990 revisionof ISO/IEC Guide 25. These two standards contained overlapping and inconsistent requirements,creating the need for a common laboratory standard that would allow mutual acceptance of testresults. In 1994, ISO CASCO WG 10 began the joint revision process.ISO/IEC 17025:2017The process of drafting ISO/IEC 17025:1999 took five years, with the Draft InternationalStandard (DIS) issued in 1998, the Final Draft International Standard (FDIS) appearing in 1999and the standard published later that year.Revisions to the 17025 standard for the 2017 release were made to ensure compatibility with ISO9001:2015. This became necessary because of the generalized adoption of quality managementsystems conforming to the requirements of ISO 9001:2015. Numerous changes were made tothe overall structure of the standard.ISO/IEC 17025:2017 also explains that while compatible with ISO 9001:2015, the two standardsare not interchangeable. Both standards provide evidence of laboratory’s commitment tocustomer satisfaction and continual improvement, only ISO/IEC 17025:2017 can be used todemonstrate technical competence.ISO/IEC 17025:2017 outlines requirements laboratories must meet to be recognized ascompetent to carry out tests and calibrations, including sampling. Its most important provisionsare Clause 4, which specifies general requirements, Clause 5, which specifies structuralrequirements, Clause 6, which specifies resource requirements, Clause 7, which specifies processrequirements, and Clause 8, which specifies management requirements.ISO/IEC 17025:2017 applies only to testing and calibration laboratories, and includes many newrequirements that were not in ISO/IEC 17025:2005, along with a number of significant changesto previous requirements.Laboratories meeting ISO/IEC 17025:2017 requirements comply, for calibration and testingactivities, with the relevant ISO 9001 requirements. Many management system elements ofISO/IEC 17025:2017 mirror those of ISO 9001:2015. Its technical competency requirements gobeyond QMS registration and relate specifically to the qualifications needed with regard topersonnel, equipment, facilities and laboratory methods.ISO/IEC 17025:2017 Executive OverviewPage 67/18
ISO/IEC 17025:2017-ISO 9001:2015 Comparison ChartISO 9001:2015ISO/IEC 17025:2017Clause 1Clause 1Clause 2Clause 2Clause 3Clause 34.1 Understanding the organization and its context4.1, 4.24.2 Understanding the needs and expectations of interestedparties7.14.3 Determining the scope of the quality managementsystem5.1, 5.2, 5.3, 5.44.4 Quality management system and its processes5.55.1 Leadership and commitment4.1, 4.2, 5.1, 5.25.2 Policy4.15.3 Organizational roles, responsibilities and authorities5.6, 6.26.1 Actions to address risks and opportunities8.56.2 Quality objectives and planning to achieve them5.46.3 Planning of changes8.57.1 Resources6.1, 6.3, 6.47.2 Competence6.27.3 Awareness6.2, 7.11, 8.2, 8.37.4 Communication6.2, 7.11, 8.2, 8.37.5 Documented information7.11, 8.2, 8.3, 8.48.1 Operational planning and control7.18.2 Requirements for products and services7.18.3 Design and development of products and services7.28.4 Control of externally provided products, processes andservices6.68.5 Production and service provision7.3, 7.4, 7.5, 7.6, 7.88.6 Release of products and services7.7ISO/IEC 17025:2017 Executive OverviewPage 77/18
8.7 Control of nonconforming outputs7.109.1 Monitoring, measurement, analysis and evaluation7.6, 7.79.2 Internal audit8.89.3 Management review8.910.1 General8.610.2 Nonconformity and corrective action8.710.3 Continual improvement8.6ISO/IEC 17025:2017 Executive OverviewPage 87/18
ISO/IEC 17025:2017 ACCREDITATIONISO/IEC 17025:2017 accreditation is a more thorough process than ISO 9001:2015 registration.This is because ISO/IEC 17025:2017 accreditation is recognition of a laboratory’s competence toproduce technically valid results, while ISO 9001:2015 registration of a laboratory is limited toQMS conformance.ISO/IEC 17025:2017 QMS and technical requirements serve as criteria for on-site assessmentssimilar to ISO 9001:2015 audits. These assessments are performed by a third-party accreditationbody, which is primarily interested in the laboratory’s ability to perform specific tests orcalibrations.Accreditation can be a valuable tool, demonstrating that a laboratory operates an efficient QMSand is competent to perform calibration or testing, leading to improved credibility, fewercustomer complaints and a strong competitive edge.An ISO/IEC 17025:2017 accreditation certificate is valid for two years, with a surveillanceassessment conducted after one year. When a laboratory is part of a larger facility, ISO/IEC17025:2017 accreditation can occur at the same time as ISO 9001:2015 or IATF 16949registration if the auditor is working for both an accreditation body and a registrar. In thesecircumstances, the laboratory must have an independent QMS from the rest of the facility.Key Steps to Achieving AccreditationBefore a calibration or testing laboratory can be considered for accreditation, several preliminarysteps must be taken:1)The first step is to implement a management system that meets ISO/IEC 17025:2017management and technical requirements.2)A Quality Manual or equivalent document must be created which stipulates the laboratory’squality-related policies, procedures and technical practices. In particular, it must contain aquality policy statement describing overall quality objectives. This document plays a vitalrole in the accreditation process. Because the manual is the principal document used duringan assessment, it must be a true reflection of the laboratory’s management system. Themanual must also address, point by point, all ISO/IEC 17025:2017 requirements.3)The laboratory’s management system must be in operation for a minimum of three to sixmonths so that employees are familiar with the system and an evidentiary trail of documentshave been created for auditors to review.After successfully completing the preliminary steps, a relationship must be established with arecognized accreditation body. The accreditation body’s job is to verify whether a laboratory’smanagement system has been properly implemented and conforms to ISO/IEC 17025:2017requirements, and if the laboratory is technically competent to perform calibrations or testswithin its scope.ISO/IEC 17025:2017 Executive OverviewPage 97/18
The scope of accreditation for testing laboratories is normally identified in terms of standard testmethods. The scope of accreditation for calibration laboratories is in terms of measurementparameter, range of measurement and best attainable uncertainties.Once the services of a recognized accreditation body have been obtained, a formal applicationmust be filed. When all of the paperwork has been submitted, the accreditation body audits thelaboratory’s quality manual and related documentation. If the accreditation body’s auditors finddocumentation gaps, they may ask the laboratory to implement corrective action beforescheduling the assessment. The laboratory may request a preassessment to improve the chancesof a successful assessment.After the accreditation body has verified that the manual and other documentation is asatisfactory reflection of the laboratory’s management system and meets all ISO/
The process of drafting ISO/IEC 17025:1999 took five years, with the Draft International Standard (DIS) issued in 1998, the Final Draft International Standard (FDIS) appearing in 1999 and the standard published later that year. Revisions to the 17025 standard for the 2017 release were made to ensure compatibility with ISO 9001:2015.
PECB-820-18 ISO/IEC 17025 LA Exam Preparation Guide Page 8 of 14 Domain 6: Conclusion and follow-up of an ISO/IEC 17025 audit Main objective: To ensure that the ISO/IEC 17025 Lead Auditor candidate can conclude a TCL audit and conduct follow-up activities in the context of ISO/IEC 17025 Competencies 1.
PECB -820 18 ISO/IEC 17025 LI Exam Preparation Guide Page 8 of 14 Domain 6: Continual improvement of a LMS based on ISO/IEC 17025 Main objective: To ensure that the ISO/IEC 17025 Lead Implementer candidate can provide guidance on the continual improvement of a LMS in the context of ISO/IEC 17025 Competencies 1.
PECB-820-18 ISO/IEC 17025 LA Exam Preparation Guide Page 6 of 14 Domain 4: Preparation of an ISO/IEC 17025 assessment Main objective: To ensure that the ISO/IEC 17025 Lead Assessor candidate can prepare appropriately a TCL assessment in the context of ISO/IEC 17025 Competencies 1. Understand and explain the steps and activities
IEC 61215 IEC 61730 PV Modules Manufacturer IEC 62941 IEC 62093 IEC 62109 Solar TrackerIEC 62817 PV Modules PV inverters IEC 62548 or IEC/TS 62738 Applicable Standard IEC 62446-1 IEC 61724-1 IEC 61724-2 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/TS 62738 IEC 62548 or IEC/
ISO 17025 Interpretation of Standard Requirements 17025 : 2005. ISO 17025 Management Requirements Technical Requirements 17025 : 2005. Contents of ISO / IEC 17025 : 2005 1. Scope 2. Normative References 3. Terms and Definitions 4. Management Requirements 5 5. Technical Requirements. 1. SCOPE
General Accreditation Guidance - ISO/IEC 17025:2017 Gap Analysis April 2018 Page 3 of 42 ISO/IEC 17025:2017 Gap analysis Purpose and background information This document serves as an informative guide correlating the clauses in ISO/IEC 17025:2017 to the previous 2005 version of the standard.
Key Requirements Of ISO 17025. The key requirements of ISO 17025 are identical to ISO 9001. Nevertheless, main focus of ISO 17025 is on the accredited test and calibration method including: Detailed sampling procedures Specific handling of test and calibration equipment ISO 17025 compliant result reports and result reporting
Initial Counseling . If you are accidentally placed on guard, weekend duty, or special duties that contradict your team orders, it is incumbent upon you to let your chain of command know IMMEDIATELY so that they can find a replacement in time. If you do not inform them within 48 hours of the duty, it is your responsibility to find a replacement. ***A change from past years: Leadership .
