N O T E ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories Prepared by : Harnisah Tajudin
Page 2 ISO STANDARD N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 CONTENTS 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 4.1 Impartiality 4.2 Confidentiality 5 Structural requirements 6 Resource requirement 6.1 General 6.2Personnel 6.3 Facilities and environmental conditions 6.4 Equipment 6.5 Metrological traceability 6.6 Externally provided products and services 7 Process 7.1 Review of requests, tenders and contracts Page 3
Page / CONTENTS 7.2 Selection, verification and validation of methods 7.3 Sampling 7.4 Handling of test or calibration items 7.5 Technical records 7.6 Evaluation of measurement uncertainty 7.7 Ensuring the validity of results 7.8 Reporting of results 7.9 Complaints 7.10 Nonconforming work 7.11 Control of data and information management 8 Management system requirements 8.1 Management system documentation 8.2 Control of management system documents 8.3 Control of records 8.4 Actions to address risks and opportunities 8.5 Improvement 8.6 Corrective actions 8.7 Internal audits 8.8 Management reviews N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7
Page / 4 verbal forms used in the document N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Shall indicates a requirement Should indicates a recommendation Can indicates a possibility or a capability May indicates a permission
Page / terms & definition impartiality : presence of objectivity Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory complaint : expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a responseis 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 N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7
Page / terms & definition proficiency testing: evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons laboratory: body that performs one or more of the following activities testing, calibration, sampling (associated with subsequent testing or calibration) verification: provision of objective evidence that a given item fulfils specified requirements. When applicable, measurement uncertainty should be taken into consideration; The item may be, for example, a process, measurement procedure, material, compound,or measuring system. decision rule: rule that describe show measurement uncertainty is accounted for when stating conformity with a specified requirement N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7
/ Control the processes via management system & structural Page PROCE S S Customer inquiry 6.2 Personnel 6.3 Facilities & environment condition 6.4 Equipment 6.5 Metrological traceability 6.6 External provided product & service 7.11 Control of data & information management 7.5 Technical records RE SOURCE 7.2 Selection verification validation method 7.3 Samplng 7.4 Handling of test or calibration item 7.5 Technical record 7.6 Evaluation of measurement uncertainty 7.7 Ensure validity of result 7.8 Reporting result 7.1 Review request, tender & contract 7.9 Complaint 7.10 Non-conforming work 8.2 Management system documentation 8.3 Control of management system document 8.4 Control of records 8.5 Action to address risk and opportunities 8.6 Improvement 8.7 Corrective action 8.8 Internal audit 8.9 Management review 4.3 Confidentiality 5 Structural 4.1 Impartiality CONTROL N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 INPUT PROCESS OUTPUT RESOURCES CONTROL ISO/IEC 17025:2017 MANAGEMENT SYSTEM REQUIREMENTS FOR FA LAB Output Customer receive report Resources required for complete the process input Process handling test item from request until job completion
/ responsible, through legally enforceable commitments management of all information obtained or created during the performance of lab activities undertaken impartially and structured and managed committed to impartiality risk to impartiality Page P P r e o r t s e onnel Data C ction I onflict of nterest Ethic Declaration of: In ESS , Mi-CID N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 ROC (Register of company) Quality Policy M4QASMRR00008 Risk Register FA Conflict of interest Declaration Clause 4 : General requirement 4.2 confidentiality confidentiality 4.1 impartiality impartiality Evidence compliance Evidence compliance
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / ROC (Register of company) for MIMOS : 336183H Clause 5: Structural requirement 5.1 Legal entity 5.2 identify management 5.3 range lab activities lab is entity legally responsible has overall responsiblity define and documented Evidence compliance Evidence compliance Organization chart M4CHRJDA00004 Job description Evidence compliance M1QASQMS00002 Lab quality manual Reference standard : MRS-6, MAGICAL SAMM Policy : SP - SP8 SAMM SC1.5
Page / responsible for lab 5.4 customers, authorities & organizations 5.5 Lab commitment define a) organization structure b) responsibility & authority all lab personnel c) document procedures for consistent application N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Quality policy statement intention & commitment Lab location Quality manual External parties Evidence compliance Evidence compliance Organization chart M4CHRDJA00004 Job description M2QASQMS00003 Documented Information Procedure Clause 5: Structural requirement
Page / 5.6 personnel specific duty Irrespective of other responsibilites, authority & resources needed :- a) implement, maintenance & improve management system b) identify process deviation from management system c) action prevention of deviations d) report to lab management on performance & improvement e) ensure effectiveness lab activities 5.7 Lab communication Lab management shall ensure: a) communication take place for management system & customer requirement b) integrity of management system is maintained N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 M1QASQMS00002 Lab Quality Manual M4AASIAR00002 Internal audit report M4QASMRR00008 Risk register FA Lab M4MRM00007 Management review minute Evidence compliance Agenda & minutes meeting (include quality system effectiveness + customer) management review Evidence compliance FA & MA Briefing Gap analysis review Training Evidence compliance Clause 5: Structural requirement
/ equipment facilities & environment conditions externally provided products & services (purchasing) metrological traceability To manage & perform lab activities, resources shall available: personnel, facilities, equipment, systems and support services Personnel Clause 6: Resources requirement Page general 6.1 6.2 6. 3 6.4 6.5 6.6 N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7
/ 6.2 personNEL Page 6.2.1 Lab personnel internal or external (contractor) shall act impartiality, competent & work accordance system 6.2.2 Document competence requirement : education, qualification, training, technical knowledge, skills & experience Evidence compliance M4AASPQM00001 Personal Qualification matrix Resume approved signatory ; SAMM Policy 6 M4AASCOA00001 Certification of authorization M4AASATP00001 Annual Training Plan Competence criteria specific post SOP for identify training need Training plan, record, matrix, evaluation & Training Need Analysis, Training effectiveness (interview staff report, certificate & test result Legal / professional certification (eg IKM) N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Clause 6: Resources requirement
/ 6.2.4 Communicate duties, responsibilities & authorities 6.2 personNEL Staff Competencies record in HRIS-ESS M4AASCOA00001 Certification of authorization Evidence of supervision CV Key personnel FA Lab Page 6.2.3 personnel competence to perform lab activities Evidence compliance Evidence compliance Acknowledge 4CHRJDA00004 Job description Organization chart N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Clause 6: Resources requirement
/ 6.2 personNEL Page 6.2.5 Procedures and retain records : competence 6.2.6 Lab authorize personnel for: a) test method validation b) analysis result c) report, review & authorize report Evidence compliance M2AASSOP00001 Personnel Procedure M4AASCOA00001 Certification of authorization Records : Training matrix, personnel information Monitoring competence Evidence compliance Job description technical personnel Competency matrix - technical staff Record actual job : FA report N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.3 Facilities & environment conditions 6.3.1 Facilities & environment conditions suitable for lab Page 6.3.2 Facilities & environment conditions documented Floor plan to show adequately provided M2QASSOP00003 Cleanroom & Lab environment Monitoring and OCAP Procedure Evidence compliance SOP test condition requirement reviewed & documented M4AASTHM00002 Temperature & Humidity Monitoring Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.3 Facilities & environment conditions Page 6.3.3 Monitor, control and record environment conditions in accordance relevant specification. Example: temperature. humidity 6.3.4 Measures to control facilities, monitored & periodically review: a) access to & use area affecting lab activities b) prevention contamination c) effective separation between incompatible area and lab Records retain: Temp & Humidity lab Data logger 6.3.5 Requirement facilities & environment applicable lab at site or outside permanent control SOP control lab facilities Physical control: partition, access, ventilation Evidence compliance Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page 6.4.1 Shall have access to equipment for correct performance lab including: measuring instrument software, measurement standards, reference material, reference data, reagents, consumable or auxiliary apparatus M4AASEML00001 FA equipment masterlist M4AASUTL00001 FA equipment utilization TUR (Test Uncertainty Ratio) - appropirate accuracy PM (Preventive Maintenance) schedule Equipment ID (physical) match with masterlist 6.4.2 Equipment outside permanent control: Not applicable due to all FA equipment permanent in MIMOS FA Lab. 6.4.3 Procedure for handling, transport, storage, use and planned maintenance for proper function and prevent contamination or deterioration. All FA equipment permanent in MIMOS FA Lab. Evidence compliance Evidence compliance Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page 6.4.4 Lab verify the equipment conforms to specified requirements before being placed or returned to service. M4AASEML00001 FA equipment masterlist M4AASUTL00001 FA equipment utilization TUR (Test Uncertainty Ratio) - appropirate accuracy PM (Preventive Maintenance) schedule Equipment ID (physical) match with masterlist 6.4.5 Equipment used for measurement shall be capable of achieving measurement accuracy of measurement uncertainty to provide valid result. Calibration report: U<= MR TUR 4:1 as minimum for calibration should be considered to demonstrate capability equipment. M2AASSOP00003 Control of equipment procedure. Calibration report & PM report U = Uncertainty equipment MR = Measurement accuracy requirement) Evidence compliance Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / measurement accuracy/ uncertainty affects test result metrological traceability (to SI unit) report in test result used for direct measurement. Example: balance to perform mass measurement. used to make corrections to measured value. Example: temperature used to obtain a measurement result calculated from multiple quantities. 6.4.6 Measuring equipment shall be calibrated Type equipment affecting validity of test result 6.4 equipment Page Calibration service report for Dual Beam, FESEM, TEM, XPS & AES Calibration certificate Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page 6.4.7 Establish, reviewed and adjusted calibration programme 6.4.8 Calibrated equipment appropriate calibration identification (labels, tags, color code) CRM expiry labelling calibration status (due date & last calibrated date) M4AASCAL00001 FA Equipment Calibration Masterlist Program include range, accuracy, frequency & trends from intermediate checks Evidence compliance Evidence compliance Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page overloading mishandling defective outside specified limit 6.4.9 Handling equipment taken out of service subjected to: Evidence compliance M2AASSOP00003 Control of Equipment Procedure. M2QASQMS00010 Control of Nonconforming Outputs Procedure Action taken: Segregation of equipment Clear label / tag Equipment put to down Repair report Verification report (compare before & after repair) Evaluation quarantine of test result/report CAR / 8D / OCPR report Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page 6.4.10 Intermediate check to maintain confidence performance of equipment fit for purpose. Evidence compliance M4AASEIC00002 Measurement Intermediate Check Stastical chart to monitor trend Risk assessment 6.4.11 Changes of calibration correction factor (measurement uncertainty) Evidence compliance Reference value CRM used for setting/ adjusting equipment. Correction factor from calibration report updated into calculation. Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.4 equipment Page 6.4.12 Practicable measures to prevent unintended adjustment from invalidating result Evidence compliance Physical devices (tag, temper-proof tape) Software program (password protected) Risk register of not adequate protection 6.4.13 Records retained for equipment which can influence lab activities Evidence compliance M4AASEML00001 FA equipment masterlist Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.5 METROLOGICAL TRACEABILITY Page 6.5.1 Maintain metrological traceability Evidence compliance Calibration equipment using reference standard or material traceable to CRM. calibration provided by competent lab. CRM provided by competent producer traceable to SI direct realization: comparison direct/directly with national/international standards. 6.5.2 Measurement result traceable to International System of Units (SI) through 3 method options: Evidence compliance CRM: MAGICAL, MRS-4.2, MRS-6, MAC Competent lab: ISO 17025 accredited (local) or ILAC-MRA (international) Competent producer: Reference Material Producer - ISO17034 & recognized international standard body (NIST) Calibrated equipment traceable to SI in National Metrology Institute of Malaysia (NMIM) or refer to SAMM Policy 2 -SP2 Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 / 6.6 externally provided products and services Page Product: measurement standard, equipment, consumable material, reference material Service: calibration, proficiency testing & audit 6.6.1 Suitable externally provided products and services (refer to purchasing and subcontracting) 6.6.2 Procedure 6.6.3 Communication lab requirement to external provider Evidence compliance M2PRCSOP00001 Purchasing and Vendor Evaluation Procedure MIMOS Procurement Policy and Procedure M4PRCSEP00002 Supplier Internal Evaluation Purchase requisition (PR) and Purchase Order (PO) M2QASSOP00001 Incoming Procedure - product acceptance criteria Supplier site visit report Clause 6: Resources requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 7 : Process requirement REVIEW REQUEST, TENDER & CONTRACT 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 SELECTION, VERIFICATION & VALIDATION METHODS SAMPLING HANDLING OF TEST ITEM TECHNICAL RECORDS EVALUATION OF MEASUREMENT UNCERTAINTY ENSURING VALIDITY OF RESULTS REPORTING RESULT COMPLAINT NONCONFORMING WORK 7.11 CONTROL OF DATA & INFORMATION MANAGEMENT
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / 7.1.1 Establish procedure for review request, tenders & contracts: a) requirements adequately defined, documented & understood b) lab capability and resources c) external provider (if any) d) appropriate test method to meet requirement 7.1.2 Customer acknowledgment on any contract deviation 7.1 review of request, tenders and contracts Evidence compliance FA Job request: sample information, customer requirement & test Communication record : Email & WhatsApps 7.1.3 Customer request a statement conformity Record on decision rules used is communicated and agreed by customer. Evidence compliance Clause 7 : Process requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / 7.1 review of request, tenders and contracts Clause 7 : Process requirement 7.1.4 Any difference between the request & contract. 7.1.5 Customer informed on any deviation from contract. 7.1.6 Contract review for amendment after work has commenced 7.1.7 The Lab shall cooperate with customers in clarifying the customer request and in monitoring the lab performance 7.1.8 Records review including significant changes and pertinent discussion with customer Evidence compliance Records of communication between customer & lab must be complete & corresponds to outcome Any requested deviation must be reasonable & not affect validity of the test result (protect interest of the lab). Customer/representative witness the test
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / 7.1.4 Any difference between the request & contract. 7.2 selection, verification & validation methods Evidence compliance ASTM E1508-12a ISO13322-1 Clause 7 : Process requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / 8.9 MANAGEMENT REVIEW 8.8 INTERNAL AUDITS 8.7 CORRECTIVE ACTION 8.3 CONTROLOF MANAGEMENT SYSTEM DOCUMENT 8.4 CONTROLOF RECORDS 8.5 ACTION TO ADDRESS RISK & OPPORTUNITIES 8.2 MANAGEMENT SYSTEM DOCUMENTATION 8.6 IMPROVEMENT Clause 8 : Management system requirement
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.2 management system documentation 8.2.1 Establish, document, and maintain policies and objectives of ISO 17025 requirement Evidence compliance MSSB Quality Policy ISO 9001:2015 & ISO17025:2017 Record staff acknowledge the policy 8.2.2 Policies and objectives shall address the competence, impartiality and consistent operation of the laboratory. Evidence compliance Quality objective competence : staff competency impartiality : Lab confidentiality & impartiality consistent operation : on time delivery, equipment availability, customer complaint, customer satisfaction a. b. c.
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.2 management system documentation 8.2.4 4 All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system Evidence compliance Document hierarchy Level 1 - 4 M1QASQMS000002 Quality Manual ISO 17025_2017 FA Lab 8.2.5 All lab personnel have access to document & record Evidence compliance Online system access Document distribution list 8.2.3 Evidence of commitment by lab management Evidence compliance Quality policy endorsed Chair management review
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.3 CONTROL OF management system documentation documents are approved for adequacy prior to issue by authorized personnel; documents are periodically reviewed, and updated as necessary; changes and the current revision status of documents are identified; relevant versions of applicable documents are available at points of use and, where necessary, their distribution is controlled; documents are uniquely identified; the unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose. 8.3.1 control the documents (internal and external) that relate to ISO 17025 requirement 8.3.2 Lab shall ensure: Evidence compliance M2QASQMS00003 MSSB Documented Information Procedure Document masterlist, amendment history, template
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.4 control of records 8.4.1 Establish and retain legible records to demonstrate fulfilment of the requirements. 8.4.2 The laboratory shall implement the controls needed for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records. The laboratory shall retain records for a period consistent with its contractual obligations. Access to these records shall be consistent with the confidentiality commitments and records shall be readily available Evidence compliance M2QASQMS00003 MSSB Documented Information Procedure Document masterlist, amendment history, template
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.5 ACTIONS TO ADDRESS RISKS AND OPPORTUNITES a) give assurance that the management system achieves its intended results; b) enhance opportunities to achieve the purpose and objectives of the laboratory; c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities; d) achieve improvement. Policy on risk and opportunitie 8.5.11 The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to: Evidence compliance Risk Register FA Lab
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.6 Improvement 8.6.1 shall identify and select opportunities for improvement and implement any necessary actions. 8.6.2 shall seek feedback, both positive and negative, from its customers. The feedback shall be analysed and used to improve the management system, laboratory activities and customer service. Evidence compliance Yearly customer feedback Opportunities log
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.7 corrective actions a) react to the nonconformity and, as applicable: take action to control and correct it; address the consequences; b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: reviewing and analysing the nonconformity; determining the causes of the nonconformity; determining if similar nonconformities exist, or could potentially occur; 8.6.1 When a nonconformity occurs, the laboratory shall: c) implement any action needed; d) review the effectiveness of any corrective action taken; e) update risks and opportunities determined during planning, if necessary; Evidence compliance Risk Register FA Lab CAR forms
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.8 INTERNAl AUDITS a) conforms to: — the laboratory’s own requirements for its management system, including the laboratory activities; — the requirements of this document; b) is effectively implemented and maintained. 8.8.1 conduct internal audits at planned intervals to provide information on whether the management system: Evidence compliance Internal audit plan, checklist and report CAR form
N O T E I S O / I E C 1 7 0 2 5 : 2 0 1 7 Page / Clause 8 : Management system requirement 8.9 management reviews a) changes in internal and external issues that are relevant to the laboratory; b) fulfilment of objectives; (review of KPI) c) suitability of policies and procedures; d) status of actions from previous management reviews; e) outcome of recent internal audits; f) corrective actions; g) assessments by external bodies; h) changes in the volume and type of the work or in the range of laboratory activities; (EOS) i) customer and personnel feedback; (suggestions from personnel on how to achieve KPI) j) complaints; k) effectiveness of any implemented improvements; l) adequacy of resources; m) results of risk identification; (Risk register and assessment report) n) outcomes of the assurance of the validity of results; and (ILC, PT) o) other relevant factors, such as monitoring activities (vendors performance – approved list, accessibility accommodation – floor plan, personnel competence- matrix) and training (training plan). 8.9.2 inputs to management review shall be recorded and shall include information related to the following: (agenda)
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