ISO 17025:2017 Lab Quality Management System Requirements, Interpretation and Implementation Dr. Ramesh R. Lakhe Dr. Rakesh L. Shrivastava Prakash H. Bhave Dr. Sapan Kumar Ganguly M. M. NaveedPublishing-in-support-of, EDUCREATION PUBLISHING RZ 94, Sector - 6, Dwarka, New Delhi - 110075. Shubham Vihar, Mangla, Bilaspur, Chhattisgarh - 495001 Website: www.educreation.in © Copyright, 2018, Authors All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted, in any form by any means, electronic, mechanical, magnetic, optical, chemical, manual, photocopying, recording or otherwise, without the prior written consent of its writer. ISBN: 978-1-5457-2975-5 Price: 3864.00 The opinions/ contents expressed in this book are solely of the author and do not represent the opinions/ standings/ thoughts of Educreation. Printed in IndiaISO 17025:2017 Lab Quality Management System Requirements, Interpretation and Implementation Dr. Ramesh R. Lakhe Director, Shreyas Quality Management System, Nagpur, India. Dr. Rakesh L.Shrivastava Professor of Mechanical Engineering, YCCE, Nagpur, India Prakash H. Bhave LQMS Consultant and Trainer Dr. Sapan Kumar Ganguly Professor of Mechanical Engineering, BIT, Bhilai M. M. Naveed Senior Consultant LOMS, Shreyas Quality Management System, Nagpur EDUCREATION PUBLISHING (Since 2011) www educreation.in1SO 17025:2017 Lab Quality Management System Chapter-1 Introduction to Laboratory Quality Management System Learning Objectives After studying this chapter, you should be able to: = Understand the importance of Laboratory Quality Management Sys Study the development of ISO 17025:2017 standard = Envisage the Process of Accreditation = Overview ISO 17025:2017 = Interpret the International Accreditation scenario. 1.1 INTRODUCTION: IMPORTANCE OF LAB TESTING AND CALIBRATION In recent years the i This is because the results of the testing are used for making the decisions. If you go to a doctor he will make the decisions about the medications based on the pathological reports you show to him. Same way the prices of many commodities like the coal which is being used in the power station are based on the test results of the coal. The gross calorific value of the coal decides what would be the cost of coal. This applies in all the laboratories as the management takes the decisions based on the results of the test and the test results can be accurate only if the calibration is being done by a laboratory which is following certain good practices. Therefore, the lab testing jportance of laboratory testing and calibration has increased significantly, and calibration has gained importance all over the world, However, the awareness about the good practices, the system which has to be developed for the laboratory is not percolated at all the levels. Even at the highest level we have found that the management is not aware about what type of calibrations are required to be carried out, In fact, in one of the good research laboratory or research organisation when Tas a consultant interacted with the director, he said that research laboratory doesn’t require any type of calibration because we are doing the research and our research papers are getting published in the international journal and therefore, why do we required to spent so much money on the calibration. This is true with most of the laboratories and in fact when we carried out one survey we found that in 90% of the central government laboratories do not have calibrated equipment’s. In fact, in most of the engineering colleges calibrations of the cquipment’s is not being done simply because of the reason that these instruments are used in laboratory for demonstration purposes to the students and therefore, the calibration of the equipments is not required. Now this misconception has to removed and there are many other good practices such as a proper system, documentation, and training, maintaining the good environment required by the laboratory, inter lab comparisons, proficiency testing,Dr, Ramesh R Lakhe ‘measurement uncertainty etc. are required to be followed in order to be really sure that that the results of testing and calibration are accurate and reliable, 1.2 WHAT IS ISO 17025? A BRIEF HISTORY For getting the laboratory accreditations, ISO 17025 lab management system standard is used. This standard describes the quality management system which is required by the lab as well as the technical requirements which are required to be followed. ISO 17025, as the nature of ISO, is generic standard, But, it significantly differs from other ISO standards because ISO 17025 covers the quality management system as well as the technical requirement and therefore it is much more useful and specifically designed for the laboratories. ISO 17025 2005 has been recently revised to 1SO 17025 2017. In fact, ISO that is international organisation for standardization has introduced different that is ISO 15189 and second is for the other testing and alibration laboratories that is ISO 17025. The laboratory management system standard ISO 17025 is based on ISO guide 25. In fact, in 1999 this ISO guide 25 was converted into a standard that is ISO 17025 1999. Thereafter this standard underwent the revision and in 2005 a new version ISO. 17025 2005 was released. This ‘was mainly because the 99 version of ISO 17025 didn’t give much emphasis on the continual improvement and therefore, 2005 version of ISO 17025 emphasize on continually improving the quality management system and also establish mechanism for achieving it How to define the quality of the laboratory is an issue which has been sorted by the ISO 17025. In fact every laboratory is proud about its outputs. In one of the laboratories we found initially that the laboratory management claimed we have the best laboratory because our results are accepted by the customers and we don’t have any complaints from our customer. Moreover, ‘we are getting regular flow of items for carrying out the testing. However, does it mean that if you have more volume of the business then the quality of the laboratory is good? It also depends ‘on many other parameters. The selection of accreditation body depends on the weather testing and calibration lab has to ibmit its reports within the country or outside the country. If the laboratory is operating at the smnational level and getting the test or calibrations samples from the viewers of other countries then intemational recognition of laboratories is required, The primary purpose of the accreditation \dards, one for medical laboratori bodies is to provide assessment of the laboratories in their countries against the requirements of ISO 17025. However, many times the international accreditation body has to cary out the assessments in other countries. Laboratory may prefer to use in accreditation body other than its ‘own country when it has to have the international recognition. And if such recognition likes then it may not be able to operate at the international level. When the results are to be used only within the country the local accreditation bodies can be chosen. In oder to bring about more simplification in the process different reasonable grouping are being formed, That is called as multilateral and that is called as imarets. The different key reasonable groupings are Asia pacifi accreditation cooperation, European cooperation for accreditation of laboratories EAL and Southem Africa development community. In accreditation SABCE The local domestic agency which is providing the laboratory accreditation has to get accredited to one of these groups. The WTO World trade organisation also requires that in order to overcome the technical barriers to1SO 17025:2017 Lab Quality Management System trade the question of global acceptance of test data as a part of quality issues at the international level has to be sorted out. Therefore, the selection of the accreditation body depends on one whether the laboratory is operating national or international level second whether the accreditation is having credibility and is functioning as per IS017011 third the credibility of the accreditation body at the international level as per the needs of imarets. Fourth the credibility of the individual laboratories which is being established by the direct assessment by either customer or accreditation bodies. Small countries with very few laboratories were not have an accreditation body it can take the services of accreditation bodies of other countries, ISO 17025: 1999 came into effective use during the first quarter of 2000 after its adoption as a national standard by most countries around the world. There are no fundamental differences between ISO 17025:1999 and ISO 17025:2005 and nothing which impinges essentially on the technical requirements. The main features of 2005 version of ISO 17025 as compared to 1999 versions are as follows: = Emphasize on commitment to continually improve the quality management system and established mechanisms for achieving this, = More focus on customer communication through feedback, su complaints. Using this information for further improvement. "Promotion of information from quality control data to evaluate the performance of the quality system and also to identify opportunities for improvement, stions and also analysis of Now after twelve years of successfull implementation of ISO 17025:2005, a new version of IS 17025 ie. ISO 17025:2017 has been released in the month of December 2017. The new version of standard was very much anticipated by the Laboratory World as numerous ch: were expected. The latest version has its design in line with ISO 9001:2015 and has 8 Main clauses instead of previous 5 clauses, Ever since its introduction, there has been a lot of anxiety about the changes that would occur in the latest version, The revised standard focuses on Risk Based Thinking in testing and calibration process approach, and also clarifies the requirements more explicitly as compared to the erstwhile version. The new version is now ISO 17025:2017 “A General Requirements for the Competence of Testing and Calibration Laboratories” and was developed jointly by ISO and the International Electro-technical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment (CASCO). Let us understand this standard in detail now.Dr, Ramesh R Lakhe P| ST iktewonin zoos |—+| sone GENERALREQUIREMENTSFOR 's0.17025:2017 | 9] Se competence or restiNG ECAenaTion LAsORATORY | comperency || ‘NationatsTANDARD ISO Guipe-25, ro 37025-2017 >] accneorrarion sopy ure 1.1: ISO 17025, Laboratory quality management system. 1.3 WHAT IS QUALITY? what customer wants; it is meeting the specifications and also means the suitability for the purpose of use. It can be understood as the benchmark of something against which other things of similar kind are measured, It is the degree of excellence of the item/service under consideration. ‘There are numerous ways of defining quality. Some of the most popular denotations for are listed below:- = A degree of excellence * Conformance to requirements ( Standards/specifications) = Totality of characteristics which satiate a user need = Fitness for use " Aptness/suitability for the purpose = Freedom from defects/errors = Delighting the customer1SO 17025:2017 Lab Quality Management System 4.4 LABORATORY QUALITY AND ITS SIGNIFICANCE For any laboratory which wants to get the accreditation has to start with the management decisions. Because, the commitment of the management and there requirement to provide the resources is must for getting the accreditations. Preparing for the accreditations is Jong and stenos process. It has (o start with the gap analysis study to identify the areas where in the lab practices differ from the requirement of the standard. Initially some trainings related to ISO 17025 2017 needs to be given to the staff so that they understand the requirements of the standards and can identify the areas where they are not fulfilling the requirements. After identifying these gaps the laboratory has to prepare a plan wherein they would try to fill up these gaps and then prepare themselves for the accreditation. These process involves the laboratory to carry out activities such as training of the employees and these training has to be related to ISO 17025 requirements and documentation another training is required related to the inter laboratory comparison and proficiency testing. Training can be related to metrological traceability and uncertainty measurement and fourth training can be related to the internal auditing of the laboratory. Once these trainings are over the laboratory should begin its process towards the accreditation by carrying out the calibration of all the equipments from the accredited laboratory or the calibration agency. They should also procure the required standards reference materials with traceability certificates. The documentations related to the ISO 17025 such as quality policy, quality objectives quality manual, quality system procedures, the test procedures and the various forms and formats which are required for record keeping needs to be prepared. Once these documents are prepared the trainings related to these documents is to be given to all the laboratory personnel. And after this training these documents are require to be adopted in the practice. After going through this process if further more changes in documentations are required because of some deviations which are taking place in the practice then they should be carried out. Simultaneously the laboratory can do the measurement uncertainty by inter lab comparison or in proficiency testing program so that they get a confidence about their results. Once, this implementation process is over, the internal audit has to be conducted and the compliances to the audit findings of the internal audit has to be carried out, After the internal audit compliances a management review meeting as per the agenda requirement of ISO 17025 has to be conducted. Now it is the time when the laboratory can think of applying for the accreditation. So form of the a tion along with all the exists which are required and the documents which are required is to be filled up and submitted to the accreditation body. After that the process of assessment for accreditations starts. Initially the accreditation body gives the registration number and acknowledges the application, If there are any disturbances in the application then these are pointed out to the laboratory which has to give the required documents and evidences for this. The adequacy audit of the documents is carried out and during this adequacy editDr, Ramesh R Lakhe audit the quality manual is reviewed. Any disturbances deviations from the requirements of ISO 17025 2017.in the quality manual then they are pointed out and these are agai required to be complied with by the laboratory. After this compliance the stage audit of the laboratory takes place and thereafter the compliances of the stage one audit finding. The stage two audit schedule stage two audit is nothing but the certification audit or the accreditation audit and after successful compliance to stage two audit findings the auditors recommend the laboratory for the accreditation. Accreditation body uses the audit findings and based on their revaluation decides to give accreditation to the laboratory. The accreditation committee can also raise some issues which are required to comply by the laboratory. And thereafter the accreditation body issues the accreditation certificate to the laboratory remains valid for 2 years during which annually the surveillance audit of the laboratory is required to be carried out. This is the process of laboratory accreditation, Laboratory quality can be defined as accuracy, reliability and timeliness of reported test results, A laboratory is a complex system, involving many steps of activity and many people. The complexity of the system requires that many processes and procedures be performed properly and the results must be as accurate as possible. It must be kept in mind that while making measurements, there is always some level of inaccuracy involved. The challenge is to reduce this level of inaccuracy as much as possible, given the limitations of our testing systems. An accuracy level of 99% may at first glance appear acceptable, but the resulting 1% error can become quite large in a system where many such events occur. For example, Gross calorific value (GCV) of coal has a very important role in deciding the price of coal, If the value goes high, the price of coal shoots up drastically favouring the coal companies and if value of GCV lowers, then it proves profitable for the thermal power stations, Therefore the outcomes depend solely on the accuracy of the testing and reporting. If inaccurate results are provided, the consequences can be very significant, including: = Unnecessary loss to the organisations = Wrong decisions * — Rejections of products/services = Legal issues * Additional and unnecessary testing cost In addition to above mentioned damages, these consequences also result in increased cost in terms of time and personnel effort put in. All aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful. In order to reliability, it is essential to perform all the processes and procedur the best possible way and in systematic and standard way. Therefore, the quality management system model, which looks at the entire system, is very important for ve the highest level of accuracy and in the laboratory inISO 17025:2017 Lab Quality Mana, -ment System achieving good laboratory performance. The various benefits of implementing good laboratory quality management system model are given in Fig.1.2 \auonvornesiars Seana osm oe ‘CONFIDENCE Sa if I ‘oancecomnonneen peranrerssseerndonuntaaunl 1 Err ong ro Figure 1.2: Benefits of ISO 17025 implementation. 1.5 QUALITY MANAGEMENT SYSTEM: Today there is a larger emphasis on Quality Management Systems in laboratories coupled with an increased recognition, that management leadership and commitment are essential to guarantee maximum quality in all activities and processes carried out in the laboratory. A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps in coordinating and directing an organization’s activities in a desired direction to meet customer and regulatory requirements. It also focuses on improving companies’ effectiveness and efficiency on a continuous basis. If such a quality management system is applied in the laboratory functioning, then it is called a Laboratory Quality Management System. In a Laboratory quality management system, all aspects of the laboratory operations including organizational structure, processes and procedures are addressed to assure the highest standards of quality. Quality management systems serve multiple purposes, including: = Systemising the work = Establishing process flows and performance measures = Developing a documented system of working * Good record keepingDr, Ramesh R Lakhe = Improving processes = Reducing waste and efforts = Lowering costs = Facilitating and identifying training opportunities = Engaging and energising the staff = Setting laboratory-wide direction The complete set of operations that occur in testing/calibration is called ‘The process flow’. This process flow’ begins with the sample received for testing/calibration in the laboratory {in some cases from the sample collection itself) and ends in reporting the results and the interpretation of results. The concept of the process flow’ is relevant to the Quality Management System, and must be carefully studied when developing LQMS. For example, a sample that is damaged or altered as a result of improper collection or transport cannot provide a reliable result, Or, a test or calibration report that is delayed or lost, or poorly written, can negate all the efforts of performing the test well 1.6 THE BASIC PRINCIPAL OF ISO17025 ‘The fundamental model for a quality management system is Deming’s Plan-Do-Check- Act cycle, which embodies the principles of scientific investigation and objective decision-making. PDCA also forms the basis of an ISO standard. It was originally developed as Deming wheel in 1951 and further modified by him as the PDCA cycle. This Deming wheel was later adopted by the Japanese as ‘Plan, Do, Check, Act’ which became integral to their Quality Control, TQC, and QC Circle activities, Deming also introduced its Shewart cycle for learning and improvement in USA in 1986 and further developed it as PDSA cycle in 1993. All the standards of ISO are based on this concept. The PDCA cycle is commonly presented as shown below - = PLAN involves clearly aligning with quality plannii = DO describes the policies, procedures, and processes for Laboratory testing = CHECK refers to quality control of the laboratory production Processes = ACT relates to actions based on results obtained, such as decisions on the acceptability of production, root cause Identification, quality improvement, ete. 1.7 AN INTRODUCTION TO ACCREDITATIO. Accreditation is a voluntary, third party-reviewed process. As a part of accreditation, a laboratory's quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISOMEC 17025. Laboratory1SO 17025:2017 Lab Quality Management System accreditation can only be granted by an authorised accreditation body. There are a number of accreditation bodies world-over, Accreditation not only facilitates the industries in enhancing the quality and reliability, but also the growth of economy of country. WTO has identified non- acceptance of test results and measurement data as Technical Barrier to Trade (TBT) and accreditation is regarded to be the first essential step towards removing such technical barriers, Realising the far reaching advantages of accreditation, it is now being given in all major fields of Science and Engineering such as biological, chemical, electrical, electronics, mechanical, fluid-flow, non-destruetive, photometry, radiological, thermal & forensics under testing facilities and electro-technical, mechanical, fluid flow, thermal, optical & radiological under ties. Accreditation is also being extended for medical testing laboratories (ISO15189) in recent times. In addition to above mentioned engineering fields, few other major sectors in which accreditations are being recognised are textiles, automobiles, power, telecom, petroleum and food industries. libration fa 1.8 WHY LABORATORY ACCREDITATION? ‘The concept of Laboratory Accreditation was first developed as a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation serves to provide formal recognition to competent laboratories, thus providing a reliable mechanism for customers to find good testing and calibration services in order to meet their demands. Thus, accreditations enhance confidence in accepting the testing / calibration reports issued by laboratories. Laboratory accreditation not only builds the trust of the customers but also gives the confidence to the laboratory management about its processes. Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results. A laboratory may apply for accreditation from as low as one to as many tests / calibrations provided by them, Classification of the Testing Laboratories is done on the basis of basic fields of testing. The laboratories doing inter-disciplinary testing of products, for e.g. textiles, plastics, building materials, metallurgical products, shall have to apply in relevant field(s) separately depending upon which field(s) the test(s) belongs. In legal issues and cases, the court asks the reports only from the accredited laboratories. ‘The accreditation granted to a laboratory remains valid for a period of 2 years, subject to satisfactory periodical (annual) surveillance. A laboratory also has an option to widen the scope of accreditation in terms of specific tests and calibrations gradually. customerDr, Ramesh R Lakhe 9 The Roles of the International Laboratory Accreditation Cooperation (LAC) ILAC is involved in developing the scheme for accreditation and has set the following objectives: = To develop the principles and the practice of laboratory accreditation * To harmonize procedures and criteria for accreditation = To assist in the development of new programs = To facilitate mutual recognition of members’ program = To reduce technical barriers in trade = To widen international acceptability of Accreditation provides independent attestation of the competence of an individual or est results an organization to offer specified conformity assessment services (e.g. testing, inspection or certification). QCI- Quality Council of India looks after accreditation of all conformity assessment bodies except laboratories. NABL ~ National Accreditation Board of Laboratories that accredits all te calibration laboratories, (Accreditations are voluntary) QCI'S MEMBERSHIP OF IAF- International Accreditation Forum NABL’S MEMBERSHIP OF ILAC-International Laboratory Accreditation Council. ‘There are various organizations in USA and Canada which provides accreditation to laboratories but other countries have only one accreditation body, some of them are listed in Table 1.1. and Sr.No. | Name of the Accreditation | Abbreviation Board Used 1 The American Association for A2LA Laboratory Accreditation 2 Perry Johnson Laboratory (PILA) USA Accreditation 3 | American Industrial Hygiene AIHA USA Association 4 | International Accreditation (IAS) USA Service, Inc.) 5 | National Voluntary Laboratory (NVLAP) USA Accreditation Program 6 | American Society of Crime (ASCLD-LAB) USA Laboratory Directors-Laboratory Accreditation Board 7 | Standards Council of Canada = CANADA, 101SO 17025:2017 Lab Quality Management System 8] The Canadian Association for = CANADA Laboratory Accreditation Standards Council of Canada (scc) CANADA 10 _ | Accreditation of Laboratories- (PALCAN) | CANADA Canada 11 | National Research Council of (NRO) CANADA Canada 12 | Calibration Laboratory (CLAS) CANADA Assessment Service 13 | National Accreditation Board (NABL) INDIA for Testing and Calibration Laboratories 14 | Komite Akreditasi Nasional (KAN) INDONESIA I$ Irish National Accreditation (INAB) IRELAND Board 16 _ | International Accreditation New (IANZ) NEW Zealand ZEALAND, 17 | Dutch Accreditation Council (DAC) NETHERLAN ps 18 | Bureau of Accreditation (Boa) VIETNAM 19 _ | Korea Laboratory Accreditation (KOLAS) KOREA Scheme 20 | A government-appointed DAKKS GERMANY institution providing accreditation of conformity assessment for laboratories, certification and inspection bodies TABLE 1.1; VARIOUS ORGANIZATIONS IN USA AND CANADA WHICH PROVIDES ACCREDITATION TO LABORATORIES:Dr, Ramesh R Lakhe x= a Tenors natal ncoption = - - 7 7 == | [etme | [ee] | escese |[ meen "Sreatate | | erat srces, pe : Management FIGURE- [AMINATION OF an LagoRaroRy | accreomranion ‘ACTIVITES ACCREDITATION PROFICIENCY TESTING cae PROGRAMME PSL TH (waa. eet NABLNEWS NABI Website ASSESSOR'S ac INTERNATIONAL To eaear apc LUNKAGES = yaaa FIGURE-1.4: NABL CONNECTIONS 1.10 ISO 17025-2017 STANDARD CLAUSES CLAUSE 1: SCOPE OF IS 17025:2017 The standard IS 17025:2017 is a reference document for the laboratories for establishing and demonstrating the competence, impartiality and consistency in operations, It is applicable to all which carry out lab activities irrespective of the number of staff1SO 17025:2017 Lab Quality Management System members, size of the lab.It is voluntary in nature. It can be used by various interested parties/stakeholders like the customers of laboratories, regulatory bodies, organizations for peer assessment, accreditation bodies, and those who are desirous of checking and reviewing the competence of such laboratory. CLAUSE 2: “NORMATIVE REFERENCE” OF IS 17025:2017 Normative references are the documents which are used while developing the ISO 17025:2017 standard and are referred in the standard, ISO. 17025-2017 uses the following standards ISOMEC Guide 99! (International vocabulary of metrology-Basic and general concepts and associated terms (VIM). ISO/IEC 17000 (Conformity assessment-Vocabulary and general principles. CLAUSE 3: “TERMS AND DEFINITION” IN IS 17025:2017 ‘The various terms and definition which are given in the ISO /IEC Guide 99 and ISO /EC 17000 have been adopted in the ISO 17025:2017 and are given and needs to be referred for better understanding and interpretation of the standard, 1.11 WHAT ARE THE MAIN CHANGES IN THE 2017 VERSION? Following are the major changes in 2017 version of ISO7025 as compared to 2005 version: = The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing. = The process approach is as per ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and ). * In line with the development in technology, this version gives stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports. = The concept of risk-based thinking is introduced, = Risk based thinking in line with ISO 9001:2015 is included. = Emphasizes more on impartiality and confidentiality as clause- 4. + Compatible with ISO 9001:2015, Clause gives requirements of quality management system (QMS). = ISO/IEC 17025:2017 aligned to ISO 9001:2015 principles. = Follows the new ISO 9001 philosophy: = Requires less documented procedures and policies. certification boDr, Ramesh R Lakhe = Focuses more on the outcomes of a process. Quality Manager, Technical Manager and their deputies not required. = Emphasis on metrological traceability through clause 6.5. jer there were 5 clauses in which 4& 5 were the major clauses. = Now there are 8 clauses. = QMS focus on document data control, control of records, internal audit, , corrective action and risk analysis and + Management review, non-conforming wor management. For Government laboratories legal identity is not necessary. FocusowinroRmarion FIGHT CLAUSEINSTEADOF alles ISKBASED THINAING 4 ey [VALIDITY OF RESURTSIN ImAPARTALIY erat conioenmaury SUT EXTERNALLY PROVIDED SERVICES STEAD OF SPEOIALFEATUREINISO COMPATILEWITHISO PURCHASE SERVICES 170252017 001.2015 ‘SUPPLIERS ‘QUALITY &TECHTCAL MANAGER & THEIR DEPUTISNOTREQUIRED [ ROLES, RESPONSIBILITY 8 1 ‘AUTHORITY FOR ALL “EMPHASIS ON LABORATORY PERSONNEL METROLOGICAL TRACEABILITY ‘CONFORMITY ASSESSMENT {LEGAL STATUSFOR GOVT SCOPE REMIsED PROCESS APPRORCH ‘ABORATORY HOT REQUIRED Fig: 1.5: SPECIAL FEATURE OF ISO 17025:2017 1.12 PROCESS OF ACCREDITATION The road map for process of Lab Accreditation is given in Fig.----. The activity begins with the management commitment and decision of preparing for accreditation. Initially the Scope of accreditation is to be decided and then the preparation such as documentation, calibration, trainings, Inter lab comparison, measurement uncertainty iency testing, quality assurance, procurement of Standard reference , Management rev calculations, prof materials, Internal audi w and submission of application to 4ISO 17025:2017 Lab Quality Management System accreditation agency is to be carried out. The accreditation agency reviews the appli \ce leads to planning stage-T ands tion and provides the adequacy report. The complia ige-II audits. z aie (an mL (aceneortanion Boot) ‘OBTAIN A copy OF APPLICATION MANA oy AeCRESIATION “Sumuarr a copies oF APPLICATION TEAS Abseesony STACEL + fikeonaToRY (oY process acoins : al mecesonny I ‘ASCREDIATION (oy FIGURE1-6: ROAD MAP TO THE PROCESS OF ACCREDITATION. LEARNING ASSESSMENT: Q.1: In which year ISOMEC 17025 was first issue? Q.2: What is ISO stand for? Q.3: What is IEC Stand for? Q4: What are the main features of ISO 17025:2005 as compared to 1999 version? Q.5: Who developed ISO 17025:20172 Q.6: Explain in brief the process of laboratory accreditation? Q7: Define Laboratory quality’ Q8: What are the consequences of inaccurate result? Q.9: What is LOMS? Q.10: What is process flow? Q.11: For how much time accreditation to lab is valid?Dr, Ramesh R Lakhe Q.12: What are the objectives of ILAC? Q.13: Why Laboratory accreditation is needed?1SO 17025:2017 Lab Quality Management System Chapter-2 Plan Do Check Act (Pdea) 2.1 INTRODUCTION: PDCA forms the basis of ISO standard. It is developed by Deming as “Deming wheel” in 1951 and further modified by him as PDSA cycle. Ishikawa redefined the PDCA cycle to include determining the goals and targets at planning stage. The Deming wheel adopted by Japanese as ‘Plan , Do, Check, Act’ was integral to the Japanese for Quality Control activities. Deming introduced its Shewart cycle for learning and improvement in USA in 1986 and further developed it as PDSA cycle in 1993. All the standards of ISO are based on PDCA o 2.2 WHAT IS PDCA? PDCA is continuous improvement tool consisting of plan (What, Why), Do(Carry out), Check(Analyse), Act(Improvement Actions). It is scientific based structured approach which helps to lead toward improvement. Figure 2.1 PDCA of LeadershipDr, Ramesh R Lakhe 2.3 BENEF OF PDCA: © PDCA approach helps in streamlining of work by reducing the time «It build up the system for creating a database that helps management to take timely decisions. System helps to synchronize the work which helps individual's workload management. * With this systemized approach, organization gets avoiding the major loss. * Helps in Improvements delegations ation of deviation thereby n the organization through balanced work distribution and * Save cost, energy and un-nes sssary efforts. Methodology for PDCA is given in table 2.1. Plan Establish objectives and how they will be achieved Do Put the plan into effect Chee Verify that the process achieved the desired results, k ‘Act Analyse any differences and their causes. Take action to improve things TABLE : METHODOLOGY FOR PDCA 2.4 LAB PROCESS IMPROVEMENT USING PDCA: Plan: ‘The purpose of this phase is to investigate the current situation, fully understand the nature of any problem to be solved, and to develop potential solutions to the problem that will be tested. 1, Identify and prioritize quality improvement opportunities in the laboratory. List the tasks to be carried out, the resources required, process flows, risks associated and plan the activities of the lab. 2. Develop an objective statement considering the following questions: a, What is the purpose? b. Who is the customer? c. What is the specific, numeric measure(s) to be achieved? d. The measurable improvement objectives/indicators? 3. Describe the current process using the flow charts, value stream mapping in order to understand the value adding and non-value adding activities to identify areas for improvements 4, Collect data on the current process covering time, people, space, cost, number of steps, adverse events, and customer satisfaction using such as Pareto charts,1SO 17025:2017 Lab Quality Management System histograms, run charts, scatter plots and control charts as per the objectives of the process, 5. Identify all possible causes of the problem and determine the root cause. Brainstorming is a useful way to identify possible causes and a cause and effect/fishbone diagram and the 5 Whys are useful for determining the actual root cause. 6 Identify potential improvements to address the root cause, and agree on which one to test. 7. Develop an improvement plan indicating what needs to be done, who is responsible, and when it should be completed Do: The purpose of this phase is to implement the action plan, 1. Implement the improvement. 2. Collect and document the data. 3. Document problem gained, , unexpected observations, lessons learned and knowledge Check/Review: This phase involves analyzing the effect of the data analysis. Compare the new data(performance) to the existing data (performance) to determine whether an improvement was achieved, and whether the measures in the objective statement were met. Pareto charts, histograms, run charts, scatter plots, control charts and radar charts are all tools that can be used for this analysis. 1. Reflect on the analysis, and consider any additional information that emerged as well, Compare the results of your test against the measurable objective. 2. Document lessons learned, knowledge gained, and any surprising results that emerged. ‘Act: This phase marks the culmination of the planning, testing, and analysis regarding whether the desired improvement was achieved as decided in the objective statement. This will involve:- 1. Standardize the improvement if the measurable objective in the objective statement has been met. Run charts or control charts are two examples of tools to monitor performance. 2. The team may decide to repeat the test, gather different data, revise the intervention, or otherwise adjust the test methodology. This might occur, for example, if sufficient data weren’t gathered, circumstances have changed, or if the test results fell somewhat short of the measurable improvement goal, In this case, repeat the “Do” phase. 3. If the changes made to the process did not result in an improvement, consider lessons eared from the initial test, and return to the “Plan” pha eC.Dr, Ramesh R Lakhe 2.5 APPLICATION OF PDCA: COMPANY DESCRIPTION, ACTIVITIE, UNDER HR DEPT Planning: While Planning the HR department prepared the Organisation chart (Designation wise) along with Roles and Responsibilities for each designation. HR dept. along with CEO of the lab prepared the Authorities chart stating the delegation. HR department planned to establish the system of review of Legal compliance, HR policies such as referring to privacy, confidentiality, impartiality, customer complaints, various HR policies and schemes. For Communication of those policies to employees and other interested parties manuals, display on website, in reception and in administrative office notice board developed. For monitoring and measuring the performances of individuals, objectives, targets are set and Software Performance monitoring system has been developed. Depending on last years competency evaluation, training needs are identified and Annual Training Calendar was prepared, Do: HR as per schedule arranged the training. Reminders are sent for refresher trainings to resp. HODs. Faculties are invited. Training records are maintained. Trainings on using and maintaining system software was given. For maintaining infrastructure and work environment well, the contracts are given for AMC, Housekeeping agencies. Supervision is carried out on outsourced work for its effective execi Sanctioning of resources and follow up with respective departments for timely submission of performance is carried out on regular basis, Records of activities performed are maintained. Check: ‘The Management reviews and different audits are conducted for findings the gaps between the planned and performed activities. The Performance measurement of staff is reviewed by respective section head and gives the feedbacks to HR. The Performance of Section heads is reviewed along with the Head HR and feedback is given to top management. HR compiles the report by finding the Positive(Achievements) and negative(Not met the targets/complaints/accidents) aspects and submit the report to top management. ‘The supervisory reports of Housekeeping, Maintenance work is reviewed and the feedbacks are communicated to the agency for correction/correetive action 201SO 17025:2017 Lab Quality Management System ‘The records of trainings: Planned vs Actual conducted, Faculty feedback, feedback is reviewed and gaps/deviations are identified. Eg. Feedback rating below 80% of faculties are listed, the list of not conducted trainings are prepared. raining Act: Based on the reviews through Performance measurement system, Management Reviews, Audit findings, training feedbacks, HR conducts a meeting in consultation with (op management and takes the appropriate actions. The minutes of meeting are circulated to respective party/staff ‘The effectiveness of actions are reviewed. SELF ASSESSMENT 1. What is PDCA? 2. What are benefits of PDCA? 3. Give example of application of PDCA in: Testing of sample Competency evaluation Internal Audit Management review aege 21Dr, Ramesh R Lakhe Chapter-3 Process Approach 3.1 INTRODUCTION: Process is a series of steps or actions linked with each other to achieve an outcome. ISO 17025-2017, process approach has given the due advantage. Process approach is a strategy in which Management gets aware about its process, inputs, outputs, interactions and Risk and opportunity involved. Knowing the process is the first step of deciding the strategy to tackle with, Adopting the process approach helps the management to take the decisions related to managing and controlling process outcomes, 3.2 WHAT IS A PROCESS? A process is a series of independent tasks that transforms an input into output material of higher value for the organization. + A process has the following characteristics: + A starting point and an end point, + A defined group of activities with defined characterist + A purpose or aim for the outcome + — Rules governing the standard or quality of inputs throughout the process. + Links to other processes. + Simple and short, or complex and long. + A process consists of steps, tasks, or activities (interchangeable terms), + Each step is depicted by a rec + Inputs (and their suppliers) are depicted by parallelograms. + The primary process is made up of those steps that everyone always does. + A parallel process is a series of steps accomplished by another, simultaneous to the primary process. + Lines and arrows show the direction or sequence of the proc specifications or needs. angle. 3.3. PROCESSES IDENTIFICATION: Process takes inputs and turns them into an output using resources and being subject to controls. Almost everything we do and all activities can be considered a process. By identifying and every laboratory we have Primary and Secondary process 22a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.1SO 17025:2017 Lab Quality Management System PROCESS MAPPING From To Process ' ro | PIER | OE ag S| ie nfo] Renny wa besaiad) tra vada eaores| aR [erat | atts 9B eoacela asoronteg| RHC cers ioe | soar chien na Pemaina) wea |_| OR eas ono epterens| uk fier act Ast |aténts. "HEM speeaey | spe UR eg] MRD 5 anon ‘ons ~ wae | Sot on wma raat wt Tage ° sree] an | "wert |, | are [Pst AH Rb) Gow, | ate ‘i st |e Mt Nt | ee ae traning | regitement lS wmewa — we |rteralEter| Al depts fee Aut | Aloe, — No, of pen Nes — uRvwooe el Aut fen ‘Schedale ne cere Teak at 1a | aR eon obg eaters] an |S wn | ates |oraes PF eto | UR spas 73 | schedule per defined im: wa Table 3.1: Process Mapping 3.10 EXAMPLES OF PROCESS MAPPING THROUGH INPUT-PROCESS- OUTPUT FOR LAB ACTIVITIES: 3.10.1 CALIBRATION OF EQUIPMENT Inputs: 1, Man: — Trained, Skilled, Knowledge about calibration of the specific equipment, fitness 2, Material: Calibration details form, Checklist for verification of certificates, Certified Reference Material (CRM), Certificates. 3, Machine: Master Instruments, Tools used, Equipment, Inspection gauges. 4, Measurement: Ideal (Master instrument reading) vs actual readi + Number of calculations vs total no of calculations, + No of equipment calibrated vs total no of equipment. + No of remarks vs total no of suggestions. + No of centificates verified vs Total no of certificates. 5, Methods: 27a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Dr, Ramesh R Lakhe ‘The sources of uncertainty affecting the results may arise from several possible input data such as a. Uncertainty of Weights and Volume measures, b. Instrumental resolution. ¢. Values assigned to measurement standards and reference material 4d. Values of constant and other parameters obtained from external sources and used in data logarithm. €. Approximations and ass procedures f. Random variations. imptions incorporated in the measurement methods and A list of possible sources of uncertainty associated with the input which contributes to the value of measurement needs to be clearly identified. Further, the size of the uncertainty associated with each potential source should be considered. Procedure for calculating Uncertainty of Measurement ‘Type A uncertainty: Step-I For each parameter, testing is carried out n (at least 10 times) times on same tes Average of test item’s results(x1, x2, x3, Mean (Xbar) = Where, n is no, of times testing is carried out (here n=10) Then calculate Standard Deviation. item, xi/n = (x1 +x2tx3+. Step-II Standard Deviation=V {(xi-Xbar)2/(n-1)] Then calculate Standard Uncertainty (U1) for type-I Step-IIT Standard Uncertainty (U1) = Standard Deviation/¥n Type B Uncertainty: Step-I Identity the sources (variables) which can affect the quality of test results like measuring instruments, such as Weighing balance, Oven, Auto bomb calorimeter, CRM/SRM, furnace and other factor as required. Step-I 1. Convert the expanded uncertainties given on calibration certificate/certificate of CRM/SRM to standard uncertainty. 1821SO 17025:2017 Lab Quality Management System Accuracy of the instrument. Hygrometer. Capacitor, Thermometer Digital Frequecy meter Step V- Estimation of uncertainty due to individual sources as below. 2. Accuracy of reading = +0.01% = 0.0001 Standard uncertainty due to accuracy Considering rectangular distribution, DOF 3. Calibration uncertainty of eapacitor = +0.15% (Mention on calibration certificate) Considering confidence level 95%, DOI factorK= 1.96 Standard uncertainty due to capacitor = Us= 0.0015/1.96 = 0.00076 Calibration uncertainty of digital frequency meter +0.6 % at K=2 and confidence level 95% Us=0,006/2 = 0.003 Calibration uncertainty of hygrometer-+1.5% at K=2 and confidence level 95%. U,= 0.015/2 =0.0075 0.0001/N3 = 5.7x10 .000057 6. Calibration uncertainty of thermometers 0.2'C at 25.26°C, K=2, CL=95%. U,= 0.2 (25.26x 2) =0,00395 Step VI- Calculate combined uncertainty due to all sources as below- Combined uncertainty = V {(0.003063)*+ (5.7x10 *p + (0.00076)+ (0, 003)" 5)°) + (0.00395)"} = 0.00953 Step VIF- Calculate effective degree of freedom as given below. Ue! /(U, 940, Jack U, hot U, foot Uy 20+ U,i00) Effective degree of freedom = (0.00953)' / {(0.003063) /9 + (5.7x10°)* foo + (0.00075) /20+(0.003)"/20+(0.0075) /ao#(0.0039) Yao} 843.38 =0 Step VIII- Estimation of expanded uncertainty using coverage factor and uncertainty budget as shown in table 4.5 . Then coverage factor (k) for Ver= 2 at level of confidence of approximately 95%, K=1.96 Expanded uncertainty = 0.00953 x1.96 = +0.0186 Final result = 0.07623 + 0.0186 1851SO 17025:2017 Lab Quality Management System 8.10 ENSURING THE VALIDITY OF RESULTS. 8.10.1 INTRODUCTION: ‘The most critical for laboratory is to ensure the results obtained from its activities are accurate, precise, reliable and consistent. For this, laboratory quality control or quality assessment plan has to be prepared. This plan would help, detect the deviations at the earliest. The quality control program involves the following: Use of reference material or quality control _materials- Laboratory needs to use the standard reference materials and also standard samples to check if the equipments are functioning properly and giving the results as expected. For example, in coal testing, benzoic acid is used as a reference material while standard coal samples are used to check the gross specific value of the coal. The laboratory has to ensure that these reference materials have the valid life, traceability and are available in sufficient quantity to carry out the checks. In water testing, some of the standard reference materials used are benzoic acid ete 1, Conducting intermediate checks on measuring equipments- It is good practice to carry out intermediate checks on measuring equipments to ascertain their performance, For example, intermediate checks using thermocouple can be carried to verify the temperature outputs in bomb calorimeter. Retesting or recalibration of retained items- The test items which are retained can be tested and cross checked with earlier results. Most of the accredited laboratory has the practice of testing at least 5% of retained samples. This can be carried out monthly or with defined periodicity considering the time and cost involved. 3. Replicate test or calibration using the same or different methods- The laboratory replicate the test and compare the results 4. Periodic checking of measuring and test _equipment- The functional checks of measurement and test equipments can be carried out.For example, the pressure gauge on bomb calorimeter can be checked or calibrated to know errors if any. Use of alternative equipment: If the laboratory has other instruments or equipment which have been calibrated, then the same can be used for cross checking the results. Uses of correlation between different characteristics of an item- Researcher have established empirical relations between the parameters of the test, For example, a regression equation of Gross Calorifie Value (GCV) with ash, moisture, sulphur and volatile matter is available in literature which can be used for correlating the resulls. Laboratory ean also develop its own thumb rules for the purpose. 7. Laboratory needs to participate _in_inter laboratory comparisons and also. in proficiency testing. This helps them to evaluate their performance and also provides the data for planning the improvements. 137a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Dr, Ramesh R Lakhe purposes. In such cases, they should be stamped as ‘obsolete’ across each page of the document One copy (or the original document) is always maintained by the originator for historical record purposes. These must be retained for a period of five years from their date of issue, after marking them ‘obsolete’ boldly across each page of the document Quality Manual, Quality System Procedures are documents specifically prepared by lab personnel, These are then presented for approval to HOD Lab, Similarly, Testing Procedure, Forms & Formats are prepared by lab personnel and subsequently reviewed by Technical Manager. However, it must be kept in mind that these documents are issued & controlled by Quality manger or any other designated person. STRUCTURE OF THE DOCUMENT For a document to be ideal and reap maximum benefit and information, it is necessary that it follows a well-designed structure and framework, It must be ensured that all the documents being generated essentially have uniformity as required under the Lab Quality Management System. There are various ways to structure the document, One of the most commonly used methods is to have a document header and footer. Document Header serves as a key to identify the document name, document number, issue date, issue number, revision/amendment number and date and page mumber. Similarly, the document footer includes information of document preparation, revision, approval and issuing authority signature, A comprehensive Master list of all documents is also prepared and maintained in the lab, indicating all the documents available in the management system. Example of header and footer uses in one of the laboratory is - HEADER Helix Coal Testing Laboratory Document No.: TY NEANUAT: HCTL QUALITY MANUAL QML Issue Date: Amend | Page No.:208 of I 201 A ssue Nou0l | 95.02.16 men Date:00 | 01 208Dr, Ramesh R Lakhe are proposed, planned and implemented. This is taken care of by carrying out the changes per the document change procedure and suggested changes are discussed in the management review meeting. For management system documentation, the laboratory needs to ensure that: 1. Policies, programs and plans related to working and functioning of the laboratory approved by the concerned management are documented and implemented at all the levels of the laboratory. These should bring consistency in operation and ensure the impartiality and confidentiality of the work. These needs to be available, in the current version, to the concerned and at the appropriate level. 3. The documents to be designed in such a way as to ensure carrying out the work to achieve the objectives. 4, The documentation needs to provide the confidence about the commitment of the management to fulfil the requirements of the standard as well as lead to continual improvement. 5. The cross references of the documents needs to done to inter link them, N DOCUMENT CONTROL, A laboratory is also required to establish and maintain procedures to control all documents that form part of its management system covering both internal as well as of external origin documents. These include papers such as policy statements, procedures, specification, calibration tables, charts, text books, posters, notices, memoranda software, drawings, plans, regulati andards and other normative documents, A + list of documents can also be prepared and maintained to identify the revision status and distribution, Each document is required to be identified distinctly. ‘This includes document number, issue number, date of issue, amendment/ revision number, date of amendmeni/ revision, page numbering, total number of pages, approving authority and issuing authority. ns, m DOCUMENT PREPARATION, REVIEW, APPROVAL AND IS SUE Every document that is issued to the personnel of the lab, is a part of the Laboratory ‘Management System and thus, is required to be prepared, reviewed, and approved for use prior to its issue. Afier ensuring the above, the documents can be issued by the quality manager or any designated person, Document Data Control procedures ensures avai bility of authorized edition of documents at all relevant locations, periodic review of documents and removal of obsolete documents from all locations, The document changes are to be carried out by the person who has prepared those documents or the one 210a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Dr, Ramesh R Lakhe 9.4 CONI ROL OF RECORDS WHAT IS RECORD? “A record is a type of document.’ Records provide evidence that activities have been performed or results have been achieved. ‘They always document the past. Records can, for example, be used to show that traceability requirements are being met, that verification is being performed, and that preventive and corrective actions are being carried out”, Records are the collected information produced by the laboratory in the process of performing and reporting a laboratory test, Characteristics of records are that they need to be easily retrieved or accessed; contain information that is permanent, and does not require updatin; Some examples of records include completed forms, charts, sample logs, testing records, quality control information and test reports, Records are laboratory information, either written by hand or computer-printed. ‘They are permanent, and are not revised or modified. They should be complete, legible and carefully maintained, as they are used for many purposes, such as: Continuous monitoring—without access to all the data collected as a part of a quality system process, continuous monitoring cannot be accomplished, Tracking of samples—well-kept records allow for tracking of samples throughout the entire testing process; this is essential for troubleshooting, looking for sources of error in testing and investigating identified errors, Evaluating problems—well-kept equipment records will allow for thorough evaluation of any problems that arise. Management—good records serve as a very important management tool. Never change a record. If new information needs to be added to a record, noted as an addition, with a date, and signature or initials. Many kinds of records are produced in a laboratory. Some examples include: Sample logbook, registers; laboratory workbooks or worksheets; — instrument printouts—maintenance records; quality control data; external quality assessment or proficiency testing records; patient test reports; personnel records; results of internal and external audits; continuous improvement projects; incident reports; user surveys and customer feedback; er ns (e.g. letters from regulatory agencies, government or administrative offices within the health care system), POLICY ON CONTROL OF RECORDS ‘An example of Lab Policy related to control of records it should be al communi as follows: 2201SO 17025:2017 Lab Quality Management System “Lab management is committed towards maintaining and controlling the records pertaining 10 quality and technical activities. It will ensure the confidentiality of the records and provide appropriate protection and security to records" ‘Terms and Definition Record: Record is a type of documents which gives the information about the happening of past or document stating results achieved or providing evidence of activities performed. iated with the ease with which information Retrievability: Retrievability is a term asso can be found. Traceability: Traceability can be defined as an unbroken record of documentation (‘documentation traceability"). Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification, Identification and Control of Records: All records used in a laboratory needs to be uniquely identified, readily available when needed, and protected against unauthorized access. Confidentiality of data and records is required to be maintained. ‘A defined procedure for identification, collection, indexing, storage, retrieval, and disposal of records would help better control of records. Records must be stored such that their security, confidentiality, quality and integrity are ensured. These needs to be maintained for the required retention time. For technical records, such as test reports of analytical measurements, original observations needs be retained, along with processing parameters that will allow tracking final results back to the original observations. Record can be maintained in hard copies or electronic media, A standard operating procedure can be prepared and implemented to protect and ensure back-up of electronic records and also to prevent unauthorized access. Records can be corrected if there are mistakes. The original information should be crossed out, but still visible. The signature of authorised person carrying out the changes is required near the changes. When electronic record systems are used, the same principle applies. The laboratory needs to ensure that original records are not overwritten by the system and that corrections are recorded together with the original records. Using a system that prevents overwriting original records and stores changes in an electronic form that can be viewed and printed is highly recommended. All quality records belonging to lab management system including audit reports, management review records, corrective and preventive action records, inspection and testDr, Ramesh R Lakhe records and contract review records are to be controlled. The primary responsibility lies with the quality manager/designated person. A documented quality system procedure control of records is required to be established and maintained for identification, collection, indexing, access, storage, protection, retrieval, retention and disposal of quality records to demonstrate conformance to quality system requirements. In must be kept in mind that records need to be identified in the respective procedures and at appropriate stages in the performance of related activities. Quality records needs to be completed legibly, stored & retained to ensure ready retrieveability to protect against damage or deterioration, Records retained longer than specified period must be separately identified. Where agreed contractually, the quality records needs to be made available by lab, for evaluation by the customer or the customer’s representative for an agreed period. The records can be maintained both in hard and soft copies, and needs to be avai at the point of use. All records needs to be maintained for a defined time period. Security and confident ble yy of records needs to be maintained, Master of the record, unique identification number, storage, access, and retention time, The laboratory needs to maintain back-up of records. Records need to be protected to prevent unauthorized access. Lab needs to identify when mistakes occur in records. Each mistake needs to be only crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records needs to be signed by the person making the correction, In case of records stored electronically, equivalent measures are taken to avoid loss or change of original data. ‘The following is the records numbering system which helps in proper indexing and easy retrieveability in any laboratory - 1. Record number is generated by using the abbreviation of the lab name, then with the functions/section it is related to and followed by the “FR” for format and then with the abbreviation of record name. For example, the lab named Helix Coal Testing Laboratory conducts the supplier evaluation of its supplier by using the format namely “Supplier Evaluation Form”. The abbreviation used for the name of the organization is “HL”, followed by the abbreviation of the section of the organization ic. purchase it is “PUR” followed bythe abbreviation “FR” for format. Then for Supplier Evaluation it is “SE”, Therefore the record number of the Supplier Evaluation form will be “HL/PUR/FR/SE”. One can also give the serial number instead of using abbreviation of the record names, in that case the record number can be “HL/PUR/ER/OI” of records gives the details N = ile numbering system. The file number can follow the same pattern followed for cord system, Here one may use the abbreviation “HL” for lab name, abbreviation for section will be “TRG” for training section file, instead of Record it is a file then K Ra You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Dr, Ramesh R Lakhe ‘They can include assessments for the purpose of accreditation, customer requirements, Jegal requirements or for license purpose. Internal Audit: The audit conducted by the laboratory with its own personnel in which the laboratory conducts assessments of all its functions/processes independently and in unbiased way. The auditor will not assess its own area. Auditor: An auditor is a person who carries out audits. Auditors collect objective evidence order to evaluate how well audit criteria ie. the requirements of ISO 17025- 2017 standard are being met. ‘They must be objective, impartial, un-biased, professional, independent, and competent, ISO 19011 distinguishes between internal and external auditors, Internal auditors perform first party audits while external auditors perform second and third party aud Auditee: An Audittee is an organization or a department/function/process that is being audited. Normally the head of the department becomes the auditee. Audit evidence: Audit evidence is the factual observations of the auditor during the audit and includes records, factual statements, and other verifiable information that is related to the audit criteria being used. Audit criteria include requirements of ISO 17025- 2017 standard, manuals, policies, plans, procedures, and requirements. Audit evidence can be either qualitative or quantitative. Objective evidence is information that shows or proves that something exists or is true. Audit findings: Audit findings result from a process that evaluates audit evidence and compares it against audit criteria, Audit findings can show that audit criteria are being met (conformity) or that they are not being met (nonconformity). They can also identify best practices or improvement opportunities. Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used, Audit criteria include policies, procedures, and requirements, Audit plan: An audit plan specifies how you intend to conduct a particular audit, It describes the activities you intend to carry out in order to achieve your audit objectives. An audit is an evidence gathering process. Audit evidence is used to evaluate how well audit criteria are being met. Non-conformity: Nonconformity is the “non-fulfillment of a requirement”. It is a failure to comply with requirements. A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties. 230,1SO 17025:2017 Lab Quality Management System TYPES OF AUDIT ‘There are three types of audit namely is describe below. t party, second party and third party audit which > First Party Audit - First-party audits are often referred to as audit of the organisation conducted by its own personnel i.e. internal audit, The auditor can be an employee of the organization or someone hired by the organization to perform the internal audit. The auditor is performing the job on behalf of the laboratory rather than a customer or certification body. This type of audit is focused not only on whether the laboratory processes meet the requirements of a standard, but all policies and programs the laboratory has set for itself. ‘The audit will look for problem areas, areas where processes do not align with each other, opportunities for improvement, and the effectiveness of the lab quality management system .By design, these audits can and should be much more in depth than the other audits, since this is one of the best ways for a laboratory to find areas to improve upon. > Second Party Audit - A second-party audit is when a laboratory performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract. These requirements may include special control over certain processes (such as soldering or welding), requirements on traceability of parts (knowing which parts are used in which products), requirements for special cleanliness standards, requirements for specific documentation, or any of a host of other items of special interest to that customer. These audits can be done on-site by reviewing the processes or even off-site by reviewing documents submitted by the supplier. The customer can audit all or part of the contract — whatever they see a need to audit It is important to understand that a second-party audit is between the customer and the supplier and has nothing to do with becoming certifi ed. > Third Party Audit - A third-party audit occurs when a laboratory has decided that they want to create a lab quality management system (LQMS) that conforms to a standard set of requirements, such as ISO 17025:2017, and hires an independent accreditation agency to perform an audit to verify that the laboratory has succeeded in this endeavor. They then provide tation to laboratory that they approve. This can be used to give customers of the Accredited laboratory confidence that the LQMS meets the requirements of the chosen standard.1SO 17025:2017 Lab Quality Management System * The audits will be carried out by internal auditors or external auditors (from other organization) as required. The audit of each section is based on ~ a) The objectives determined for the section being audited and other related targets and plans. b) The requirements stated in related quality procedures and any other work instructions. ©) The requirements of the ISO 17025:2017 standard ‘The audits are conducted using a judicious mix of - a) Interviewing selected staff, including senior management. b) Selecting samples of important records generated during the interval between audits. ©) Witnessing important processes, d) Observing and reviewing housekeeping in the area, ©) Overall upkeep of the laboratory 1) Interviewing, observing and checking. ‘THE AUDITOR SHALL - a) Ensures objectivity and impartiality of the audit process. b) Use the defined plans and programs to carry out the audit, ©) Remains objective in his approach d) Ensure that the findings are based on f i) Are recorded in a clear and simple language in the designated formats. ii) Contain adequate information about any deficiency found such that it can be verified later on, Indicate why it is a deficiency or deviations, Include any positive aspects observed. Are treated in a confidential manner and discussed only with the management of the area and the QM or designated person, ©) Prepares the audit plan, notes the observation in “Audit observation report” and records the nonconformance on “Nonconformance report” £) Verifies the corrective action and prepares “Internal Audit Summary Report” and submits it to the QM or designated person along with NCR’s and “Audit observation sheet” ts and: Personnel designated for carrying out the audit process ensures that the audits are carried out as planned and reports are prepared and records maintained, ‘The sectional head and other auditee involved ensure co- operation and assistance to achieve objectivity in the audit.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.1SO 17025:2017 Lab Quality Management System ¢ Corrective Action proposed Person responsible for corrective action : ~ Date by which corrective action will be implemented: Signature of Auditee : D Verification of Corrective action proposed: Auditor Date : E Verification & closure by Quality Manager 9.5 CORRECTIVE ACTION WHAT IS CORRECTIVE ACTION? Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence. This is a reactive action that eliminates problems identified i product, service or processes and takes care of the immediate problems. Non Conformity: Nonconformity is the “non-fulfilment of a requirement”. Itis a failure to comply with requirements. A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties pDr, Ramesh R Lakhe b. Records of preventive maintenance c. Records of evaluation of suppliers 4, Records of non-conformities ¢. Training records f. Customer complaints g. Internal Audit/External Audit finding ‘The causes of non-conformities needs to be determined including potential non- conformities, Cause analysis shall be carried out to include the customer requirements, samples, methods and prok ff skills and training, consumables or equipment and. its calibration, The need for action needs to be evaluated to ensure that non-conformities do not re-occur. The probable correetive actions shall be recorded in “Corrective Action Form”. The possibilities of initiating the Corrective actions (CA) after analysis of all the causes needs to be discussed. Corrective actions are implemented on trial basis and effectiveness verilied & if required suitable changes shall be made in document. The analysis of Corrective Action needs to be taken for discussion and review Management Review Meeting. Continuous improvement activities need to be planned by the lab in their work to make the improvements in overall working Whenever any nonconformity with respect to established processes is detected it needs to be recorded in non-conformance register, immediate action to correct the nonconformity, if possible shall be taken by the quality / technical manager. Root cause analysis is carried out by technical/ quality manager or designated person where the non-conformity was detected. Depending upon the results of the analysis corrective action is initiated by the person responsible and recorded in the non- conforming register. The resources required shall be estimated and forwarded to management for approval. If the problem requires intervention of more than one department then the CA shall be circulated to the departments for finding the root cause and corrective actions. The causes of non-conformities shall determine including potential non-conformities, Cause analysis shall be carried out which include the causes like the customer requirements, materials- samples, machines, milieu, methods and procedure, staff - skills and training, consumables or equipment and its calibration and sub-cause & sub-sub causes thereof. The need for action shall be evaluated to ensure that non-conformities do not re-occur. Corrective actions details shall be shared during the management review meetings, 10 prevent the recurrence of the non-conformity due to same cause. Analysis of the same shall be carried out every year. Non conformities generated in internal / external audits shall be reviewed for their effectiveness by quality manager. The summary of non-conformances and its corrective action of internal / external audits shall be presented in management review by quality edure, 2421SO 17025:2017 Lab Quality Management System manager. make the improvements “ontinuous improvement activities shall be planned by the lab in their work to in overall working. 9.6 CASE STUDY An accredited coal testing lab M/s Rama Coal Testing Lab that conducted its internal audit as per Lab quality management system and internal audit. The lab has following parameters for accreditation like, proximate analysis of coal (Ash, Volatile Matter, and Moisture) and GCV analysis, They receive coal from various coal suppliers (who supplies coal to power station). The lab is open to others. The lab is headed by In charge of Lab as a Chief Executive of Lab. The quality and technical manager of the lab were appointed as per their appointment letter dated. 21.05.16. The lab has other staff members namely a chemist and a technician, Chemist performs the work and technician helps i preparation of coal sample for testing. The quality manager Mr. Alex looks after all the activities related to quality management system/management requirement while, Mr. Sushant the technical manager looks after all the activities related to technical requirement, They both report to Mr. Ashutosh the chief executive of lab. The Chief Executive of the lab reports to the Director/owner of the company. The lab has very well defined quality policy, quality objective, quality manual, quality system procedure, test procedure and forms and formats required for lab quality management system. The technical requirements are also in place. ‘As per the internal audit calendar the internal audit is due in the month of April-16 it was conducted in the month of June-16, They have given the work of conduction of internal audit to agency named Shreyas Management System. They have well experienced and trained auditor in the field of lab quality management as per IS 17025. ‘The two of the auditor conducted the internal audit for their management requirement and. technical requirements. Various NCR were raised during the internal audits they are, NCR-O1 List of IS standard used for the testing such as IS 1350, ps its amendments from the respective website or departments. and Il are not verified for NCR-02 List of supplier is not updated for its current available supplier list. Example M/s Shyamlal Agency who supplied oxygen cylinder to the lab is not enlisted in the list of supplier (QMR/FR/LOS).a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Sr. No. NCR. No. 1SO 17025:2017 Lab Quality Management System NOR Details Corrective Action 7 List of IS standard used for the testing such as IS 1350, part-| and Il are not verified for its amendments from the respective website or departments. The lab will verified the amendment number from the respective departments and from the website. List of supplier is not updated for its current available supplier list. Example M/s Shyamlal Agency who supplied oxygen oylinder to the lab is not enlisted in the list of supplier (QMR/FRILOS). Lab conduct the measurement of uncertainty calculations on yearly basis particularly after the calibration but it is evident that no raw data book is prepared for all Mis Shyamlal agency will be incorporated in the list of supplier. The Raw data book for all the parameters will be prepared onwards either for MU. calculation or ILC analysis and record of the same will be the repeatability conducted for | maintained. MU estimation Calibration status of the} Calibration status of the equipment’s is not displayed on the equipment. equipment's will be displayed on the equipment. &Dr, Ramesh R Lakhe ‘Non-Conformance Compliance Report SNo |” NCNo, & Non-Compliance Raised T | i: Procedures mentioned in QM. tobe separated to MSP (Management System Procedures. The MSP needs oe developad into mania format covering all rocedures connected 10 QM. Some procedures like Recruitment and ‘raningevauation of taining, UM procedure, Handing of test items, equipment maintenance tobe developed Corrective Action Taken By The Laboratory And present status of Some procedures refered in QM. were separately documented and remaining were inched in QI. tse Now all the procedures mentioned in QM. have been separated and “Procedure Manual" overing these procedures along withthe atonal procedures as suggested during asessment ha been developed. The revised Quality Mangal and Procedure Manual ae enclosed 2: The Lab, should wainain reeonls of evolution ‘of eiticalchemicals'consomables to asure their compliance with standard specifications Earlier deals of ll emicals including their batch no. received in Lab. were maintained, The critical chemicals are now being checked for der spevified sandands before puting into use. An extract of checking register is prepared 3 _| 3: ahoraty should mainin a regisier covering root cause analysis and comective actions on customer complaints, Non conformities observed during the working, NCS Foul during adits and preventive ations and contol it fr belping improvement purpose ‘The record of all NCS was Being maintained earlier ina ‘consolidated form, Separate registers are now maintained ‘covering rot cause analysis and corrective aetons on cexstomer complains, Non-conformities observed during the working, NCs found during audits and preventive aesions and control thereof. The specimens ofthese registers are enclosed. These registers willbe maintained forall tue NCs observed during the working and ints 7 Te ammo atone wae ba mda 1) canner isc Reco ofasmer | trol ethack fos ad wor compton repr Cpt i Recltcatomet | ih wu gcd MMs ance sea Fanaa ‘would be taken, However in view of NCs raise following oF test nok manta action is initiated: Rel f elite eulome 1) Thecsome visited hs en ind eceters and thei feedback is being studied. The 2) Rico of anys som stacks Ata ede eat he peromsne of The esece eed Reo of Raw Tes Dat poet Ui tenga rine en como. care any rion ented daring eng ws etd on Dts ey, Now ; tera est dat being maine by sig ute honey tos hich wl eet Th eiene oftheisendoed 6 Environmental monitoring Equipment to be | The environmental equipment i.e. Sling Hygrometer provided in each segmented area of permanent he, which was being used earlier is being replaced now with wet and dry bulb hydrometers. Each ofthese equipment isbeing provided in each of segments. The evidence to this effet is enclosed 3Dr, Ramesh R Lakhe Risk: A probability or threat of damage, injury, liability, loss, or any other negative ‘occurrence that is caused by external or internal vulnerabilities, and that may be avoided through pre-emptive action. 9.7 MANAGEMENT REVIEW WHAT IS MANAGEMENT REVIEW? ‘Management review is a formal meeting of top management with the purpose of reviewing and evaluating the effectiveness of the quality management system. Policy on Management Review “Lab management is committed to review the performance of the all processes of the laboratory and associated functions during the management review once in six months to ensure the continuing suitability and effectiveness of laboratory’s management system for its testing activities to introduce necessary changes and improvements, Plant Head or Vice President (O&M) will chair the meeting while Quality Manager will co-ordinate the meeting. All the members of the Senior Management having overall responsibility for implememation of laboratory's. management system will be the members of the management review committee and will participate in the meeting. Management is committed to provide the necess agreed time period”. ary resources and implement the actions planned in Terms and Definition: ‘Management Review: Management review is a formal meeting of top management with the purpose of reviewing and evaluating the effectiveness of the lab quality management system. Management Committee: A group of people who are chosen by the organization to make decisions about how an organization is run and to make sure that particulars jobs are being done. Agenda: An agenda is a list of meeting activities in the order in which they are to be taken up, beginning with the call to order and ending with adjournment. It usually includes one or more specific items of business to be acted upon. It may, but is not required to, include specific times for one or more activities Minutes of Meeting : Meeting minutes keep an official account of what was done or talked about at formal meetings, including any decisions made or actions taken, They are taken during a formal meeting of the board of directors or shareholders of a corporation, such as initial and annual meetings. 248a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.ISO 17025:2017 Laib Quality Mana -ment System Chapter-11 REPORTING RESULTS Learning Objectives: This chapter covers: = Requirement for the preparation of report; = Specific requirement for test report; = Specific requirement for calibration certificate; + Reporting requirement related to sampling; atement and report; = Reporting requirement related to opinion and interpretation; = Method of amending the report, + Decision rules related to conformity s 11.1 INTRODUCTION: Test report is a document of utmost importance not only for the laboratory, but for the customer as well, It presents information about the test performed and test results obtained, thereby becoming the final document for decision making. It is, therefore, required to be prepared with maximum care, clarity and accuracy so that there is no ambiguity in its interpretation. It must also provide for objectivity in decision making. 1SO 17025:2017 standard disseminates guidance regarding the information to be included in reporting along with the results which can be used for preparing for the final format for the report. The following points must be observed while preparing the test report: 1, It must specify information about the laboratory performing the test; including its name, address, location, contact person, telephone number and email so. that anybody can contact the laboratory easily. 2. It should provide all the information about sampling, test method, reference standard used, customer name and contact detail, identification number, environmental conditions, equipments used and standard reference data, date of testing, person testing and authorization, This will ensure traceability in future, 3. The reports needs fo be clear, accurate and needs to be approved by authorized person, Details to be included in the test reports are given in figure 11.1a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.ISO 17025:2017 Lab Quality Management System 783 ‘STATEMENT OF CONFORMITY: DECISION RULES ENVIRONMENTITEST CONDITIONS UNCERTAINTY MEASUREMENTS [ oPwions! TesTREPoRTS —_, —~|_ SAMPLING INTERPRETATIONS | SPECIFIC REQUIREMENTS |__| cuSTOMER ——- INSTRUCTIONS FIGURE-11.8: TEST REPORT CONTENT Itis crucial to include various bits of information required by the customer (as stated in the agreement) and all such information is required for interpretation purpose. The report needs to also indicate test method applied for conducting the analysis. The teste ence, to avoid any further inconvenience and maintained as a techni bration report issued to customer is required to be retained as a refe record. Sometimes test reports are called ‘test certificates’ and ‘calibration reports’ Laboratories may generate and release these test/calibration reports either in the form of a hard copy or as a soft copy (electronic means) but all care must be taken to ensure that lab follows the requirements of this standard i.e, ISO 17025:2017. In accordance with the terms agreed with the customer, lab may generate a simplified version of report. Care needs to be taken to ensure that, any information required to be made available as per requirement is not provided (tested) in the report then it must be specified in report. Every report generated by the laboratory must have the following information, unless and until it is having any reason for not including the same so to avoid any misuse or misunderstanding: a) Title of test or calibration report such as “test report” and “calibration certificate”. b) Proper and complete address of the lab. ) It is necessary to mention the location of lab where the activities are being performed. Details must be provide separately for activities carried out within the lab, those which are performed at customer site or away from the lab permanent facility, mobile facility ete. d) It should have a unique identification number clearly mentioned at the end of the report. ©) Customer name, contact detail must be added. 1) Reference method or identification procedure used.a You have either reached 2 page thts unevalale fer vowing or reached your ievina tit for his book.Dr, Ramesh R Lakhe ANNEXURE A QUESTIONNAIRE FOR QUALITY MANAGER/FOR IN-CHARGE QUALITY MANAGEMENT SYSTEM AS PER ISO 17025:2017 Questionnaire 1. NABL, IEC and ISO stand for? 2. Who are Quality manager & Dy. Quality Manager? Who is your Technical Manager & Dy. Technical manager? 3. Which date letter of appointment prepared? In which clause of IS/ISO/EC 17025 appointment of Quality manager is mentioned? 4, Who are the Authorized Signatory? 5, What are the documents designed for NABL system? 6. What is the Quality Policy? Explain any two? 7. What are the Quality Objectives 8 9. I 1 What is the Performance Report? List down any four Quality System Procedure required as per IS 17025? 0. Which clause states about control of documents? 1. Which clause state about document change and what is the document no. of format or forms? 12. Which clause of ISO 17025:2005 is not applicable/ excluded and which document it is mentioned? 13. Complaint procedure is described in which quality system procedure? As per which clause of 17025 it is prepared? 14, What is meant by correction, corrective action and preventive action? 15. What is the difference between document and record? 16. What is the frequency set for internal audit as per Quality Manual 17. Note down any four points that should be discussed in review meeting? As per which NABL documents it is revised? What is the frequency of Management Review Meeting? 18. Which clause stated that test and calibration equipments (including both software and hardware) shall be safeguarded from adjustment? 19. Who are the customers of the lab?35. 31. 38. . Is the Evaluation of supplier ear 1 ). List down the total staff list available in coal testing section? How many? 1SO 17025:2017 Lab Quality Management System Is the How Index is calculated? Which system is adopted for making changes in documents? Which changes are made in the documents so far? The copies of document change note in above respect. The obsolete copies of same. The respective changes in Master List of Document. ‘The new document distribution list. What are the external origin documents? uustomer satisfaction survey is carried out? What is the frequency of . Who are the certified internal auditors mentioned in the list . Which are the recognized training institute for the training Lab management system and internal audit as per IS 17025:2005 and Measurement uncertainty calculation? What are the criteria mentioned in competence matrix of the organization? . How many Non conformity rose in Stag-I audit? How many suppliers are there for supplying consumables and other services? dout? down the staff available particularly for testing only? How many? Who has attended four days training program on IS 17025 and on MU calculation? . How many training program as per internal training calendar is design? . Which are the training faculties enlisted? . How do you ensure impartiality, confidentiality and operational integrity in your laboratory? Which document is available with you to show legal status of your laboratory’? . Where is your organization chart? Who is the head of the laboratory? What are the responsibilities of the Quality manager, Dy. Quality manger, Technical Manager And Dy. Technical manager? 39. 40. Al. 42, 43. 44, 45. 46. 47. 48. What is the documentation structure for your laboratory? Which is the reference standard used by your laboratory for testing? What is the process of maintaining obsolete document? How do you carry out evaluation of supplier? What is the frequency of management review meeting? What points are discussed in management review meeting? What is the purpose of internal audit? When will you carry out additional audit? What is the methods use in internal audit? When is the internal audit report reviewed and discussed?Dr, Ramesh R Lakhe ANNEXURE B QUESTIONNAIRE FOR TECHNICAL ASPECTS AS PER ISO 17025:2017 Questionnaire 1. NABL, IEC and ISO stand for? Who are Quality manager & Dy. Quality Manager? Who is your Technical Manager & Dy. Technical manager? 3. Which date letter of appointment prepared? In which clause of IS/ISO/EC 17025 appointment of Quality manager is mentioned? Who are the Authorized Signatory? What are the documents designed for NABL system? What is the Quality Policy? Explain any two? What are the Quality Objectives? What is the Performance Report? List down Quality System Procedures required particularly in Clause 5 as per IS 17025? 10, What is the scope of the lab? OR Which test you have applied for? 11. Have you written test procedure for it? 12. Have you calculated Z the acceptable range for Z score 3. If yes, on what basis you decided the acceptance? 14, What is meaning & significance of Z score? 15, Have you taken any training related to 1. Technical, 2.NABL 16. Which precaution have you taken while carrying out the test? 17. Which are the indicators based on which you evaluate- whether the result is accepted retested rejected? 18, What is repeatability & reproducibility? When & why you carryout these tests? 19. How you carry out the maintenance of your equipments? What is the QSP for Maintenance of equipments? 20. What is the calibration frequency of the lab? 21. Who is the agency calibrated the equipments? Is the scope of calibration lab is checked? 22. Calibration certificate is checked or verified? ws eens core for this test & whether it is in accepted range? What are1SO 17025:2017 Lab Quality Management System 23. What are the environmental conditions required for carrying out this test? 24, What is the procedure for receipt of sample? 25. How is the process of corrective and preventive action? 26. Which are the external QC? What is the action when the test 27. List down the name of three laboratories currently taking part in ILC? 28. Who is the authorized person for handling non conforming of testing work? 29. How is traceability ensured in lab? 30. Is the Quality Assurance Plan existing in the lab? Which are the points covered in it. 31. Is the Measurement of Uncertainty calculated for ils? ich parameter? 32. What are the frequency of checking housekeeping checklist who is authorized to do so? 33. Is the daily environmental condition is checking if checking what are those? 34, Which is the format used for Preventive Maintenance of equipment 35. How many repeatability test to be conducted monthly?Dr, Ramesh R Lakhe ANNEXURE C ISO 17025-2017 As Name: Designation: Contact No. & email: Answer the following questions. Clause -1 QI: What is Lab Accreditation? Q2: What are the changes in accreditation proce: Q.3: When was ISO 17025-2017 was introduced? Q4: How many clauses are there in ISQ1705-2017? Q5: List any five major differences between 2005 version and 2017 version of ISO 17025-2017? Clause-4 Qc: What is meant by impartialit Q.2: What are the factors affecting impartiality? Q.3: List few ways to ensure impartiality? Q4: What is confidentiality? Q5: Who is responsible for maintaining confidemtality at work place? Q6, What actions are required to ensure confidentiality? Clause -5 Q.1: What does the clause -5 of ISO 17025-2017 states? Q.2: Which is the document which shows legal entity of the lab? Q.3: How laboratory represents its management structure? Q.4: Mention any two responsibilities and authorities of HOD of laboratory? Q5: Whether government lab needs to get any legal entity? Clause-6 A. Qu: Define competency. Q.2: What are the factors which affect competency of a person working in a laboratory? Q.3: What are the various tasks in laboratory which require authorization? Q44: How would enhance the competency of personnel? B.Q.1: What equipments are available in your lab? List any three, How do you ensure the maintenance of these equipments?Dr, Ramesh R Lakhe Document Data Control/Quality Manager (Quality assurance Plan’ Quality Indicator chart Document distribution list Document change not if any master list of docuemnts master list of records wlolula|w lela List of quality system procedure List of internal auditor document review report 10 List of external origin document 11 Content of firs aid box 12 List of Files 13. List of Register 14) List of Manuals 15 Corrective and preventive faction form. Internal Audit Internal audit calender Internal audit schedule internal audit observation record NCR (Wih Signature and Corrective Action) Internal audit summary Report List of Internal auditors Manaj ement Review Meeting Formation of Management Committee Circular for Management Review Management review meeting minutes with action plan »1SO 17025:2017 Lab Quality Management System ae inter Laboratory Comparision? F a [otters smeetive oF »Dr, Ramesh R Lakhe AUTHOR’S PROFILE Dr. R. R. LAKHE Dr. R. R. LAKHE, is presently working as Director , Shreyas Quality Management System, SQMS , Nagpur. He is registered Sr. Consultant for IS09001-2015 QMS and ISO 17025 LQMS with Quality Council of India and is recognized Lean consultant. He persues both academic & professional interest. Deeply interested in learning, he has completed, in addition to his PhD in Industrial Engineering, Masters in Management, Sociology, Public Administration, Training & Development. He is Qualified Lead Assessor for ISO9001 QMS, ISO14001EMS,ISO 50001ENMS & OHSAS 18001. He is Master Black Belt Six Sigma. Academically he has guided 14 PhD scholar in both Nagpur & Amaravati University. He is member of RRC in Mumbai University. He is Co-author of Two books; “Handbook of Total Quality Management’ & “Total Quality Management for Service Sector’ (Published by JAICO Publication). He is reviewer for International Journals published by Emerald, Taylor & Francis, Inderscience etc. He is on advisory boards of number of engineering colleges. Professionally he has provided training & consultancy to more than 200 nisations at national & International level on various performance improvement aspects such as Quality Award, IS09000, IS014000, ISO50001 ENMS,OHSASI 8000, 1$022000,1SO17025, 5 S, Kaizen, Six Sigma, NABL accreditation, FAMI-QS,BIFMADr, Ramesh R Lakhe Prakash Harihar Bhave Shri Praksha Harihar Bhave is retired from Ministry of Communications and IT, Govt. of India; “Electronics Regional Test Laboratory (ERTL), Mumbai as Senior Director. He is basically B.Tech. (Electrical) from IIT, Mumbai. He has more than 35 years of experience in the field of Quality Assurance and Laboratory management, Testing and Products Certification; Calibration of electro technical parameters and process parameters; Reliability evaluation, International compliance certification schemes such as CE marking and Safety mark. He has provided assessment services for ISO 17025; ISO 9001 and ISO 27001,and Schools Governance (QCI Standard). He has done more than 100 NABL accreditation assessment as a Lead Assessor and Technical Assessor, assessed more than 15 school for accreditation as per QCI and many more assessment of ISO 9001. He is providing training and conducted many training program for 4 days awareness and internal audit training programs for IS01702 for laboratory personnel. He has been associated with many professional organization such as he was Chairman Quality Forum , Mumbai, Ex President - International Society of Reliability Engineers (India chapter),Fellow of Institution of Engineers and Chartered Engineer, Fellow of Institution of Electronics and Telecom Engineers.image not availableimage not availableISO 17025:2017 Lab Quality Management System Requirements, Interpretation and Implementation Laboratory accreditation has assumed immense importance in recent years because of the need to assure the customer that the laboratory is capable of providing the valid test results reliably. ISO 17025:2017 Lab Quality Management System has become part of the requirement of all the laboratories, small to large. Over the years, ISO 17025:2017 Lab Quality Management System has evolved, as per the laboratory and customer requirements, and has become very important for improving laboratory systems and processes in order to sustain competitive advantages. This book focuses on requirements and key features of ISO 17025:2017 Lab Quality Management System such as risk-based thinking, PDCA approach, process management, and continual improvement. The readers would find it easier to understand the standard requirements and implement these in their work place. Salient features 1. Each Clause and sub Clause is illustrated through block diagram for easy understanding. 2. Evidences required for compliance to the clause are provided. 3. Numerous examples, case examples and case studies from different laboratories are included for the benefit of the readers. 4, Standard requirements expressed through process approach. 5. Pedagogical tools such as chapter objectives, audit questions, flow diagrams, and learning assessments have been used, Special focus on risk based thinking and documented information provided. Management discussions to illustrate the Clause requirements are included for better understanding and readability. The forms and formats, key performance indicators/objectives, standard operating procedures and audit requirements are included No You may reach author at: A samssixsigma@gmail.com 0] EDUCREATION Wi NN PUBLSHING