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NABL

NABL. Which Laboratory you will prefer to go?. ABC. Having untrained staff Having old deviated instruments Having Expired chemicals Having poor housekeeping. XYZ. Qualified and Trained Staff Calibrated instruments Valid Chemicals Proper storage mechanism Good Housekeeping.

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NABL

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  1. NABL

  2. Which Laboratory you will prefer to go?

  3. ABC • Having untrained staff • Having old deviated instruments • Having Expired chemicals • Having poor housekeeping

  4. XYZ • Qualified and Trained Staff • Calibrated instruments • Valid Chemicals • Proper storage mechanism • Good Housekeeping

  5. What more do you expect from Good Laboratory?

  6. What is ISO?

  7. ISO: International organization for standardization, located in Geneva • Purpose: To Establish Quality Standard framework throughout the world • First released its standard ISO 9001:1987

  8. NABL National Accreditation Board for Testing and Calibration Laboratories (NABL) is the sole Laboratory Accreditation body authorised by Government of India (GOI). NABL is an autonomous body under the aegis of Department of Science & Technology (GOI). The accreditation to testing and calibration laboratories are granted in accordance with ISO/ IEC 17025: 2005 and medical testing as per ISO 15189: 2003. NABL has established its accreditation system in accordance with ISO/IEC 17011: 2004 which is followed internationally.

  9. COMPETENCE OF A LABORATORY • In evaluating the competence of a laboratory, the following methods are used: • On-the-spot assessment of the laboratory by the experts. • By evaluating the results of a particular test/measurement in a proficiency testing programme.

  10. International Standards and Guides applicable to laboratories • ISO/IEC 17000 : Conformity assessment - Vocabulary and general principles • ISO/IEC 17025: General Requirements for the Competence of Testing & Calibration Laboratories • ISO 15189 : Medical Laboratories - Particular Requirements for Quality and Competence

  11. Functions of An Accreditation Body • To promote the development and maintenance of good practice in testing and measuring • To establish and maintain international recognition for its national accreditation programmes

  12. Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing etc. Clinical Forensic Electro-Technical Mechanical Radiological Thermal & Optical Fluid-Flow etc NABL Accredits For: Testing Laboratories Calibration Laboratories

  13. Accreditation Procedure by which an authoritative body (NABL) gives formal recognition that a body (laboratory) or person (signatory) is competent to carry out specific tasks (scope) • Criteria - ISO/IEC 17025 (includes all those requirements of ISO 9001 relevant to the scope of laboratories) • Assures the client that the procedures and test results are technically valid • Recognizes the technical competence of laboratory staff • Endorses the the laboratory operates the the management system effectively

  14. BENEFITS OF ACCREDITATION • National and international recognition • Public and industry acceptance • Assurance to clients of good laboratory practice • Provides global equivalence • Provides comparability in measurements • Decision makers can rely on test results • Improves staff motivation • Ensures better support in the event of legal challenge • Saves money by getting it right at first time.

  15. Information About Laboratory Required by NABL • Testing /Calibration • In-house/Open to others /Partially open • Fixed/Mobile • Legal status • Name of the Lab

  16. 1. Lab is responsible for all legal requirements. 2. Testing and Calibration activity for - 1. Customer needs 2. Regulatory authorities. 3. Organizations providing recognition.

  17. 3. Scope of Management System • Labs Permanent facilities • At sites away from Permanent facilities • Associated temporary or mobile facilities • If the Lab is part of larger organization • -> Departments having conflicting interest do not adversely influence the interest of lab.

  18. 4. Testing Requirements • Impartial • Personnel are free from any undue commercial financial and other pressures which might influence their technical judgment • Confidential • Integrity

  19. 5. Managerial & Technical Personnel • * have authorities and resources needed to carry out their duties. * to identify the occurrences of departures from the management system or from the procedures for performing testes/ and / or calibration * to initiate actions to prevent or minimize such departures. b) Free from any internal or external pressures

  20. c) Policies and Procedures for protection of • Its customer’s confidential information • Proprietary rights • Electronic Email.

  21. Policies and Procedures for • Protection of customers confidential reports • Property rights • Protecting the electronic storage and transmission results • Having confidence in its competence, impartiality, judgment or operational integrity.

  22. Organization Chart A

  23. Organization Chart B

  24. Organization Structure • Who is Q.M. /T.M./Dy QM/Dy TM ? • Can all be one person? • What is NABL requirement for QM? • What should be responsibilities of QM and TM?

  25. Quality Manager (QM) Responsibilities • Day to day administration lab. • To maintain discipline, safety within the lab. • initiating needs for training of lab personnel. • Checking for effectiveness for testing & management systems. • Attending customer complaints and customer feedback and conducting customer satisfaction survey. • To conduct management review meetings& internal audits • Establishing, implementing & maintaining the laboratory management system as per IS/ISO 17025: 2005. • Liasioning with NABL for Laboratory accreditation and managing associated activities • Preparation of Test Report • Reports to Director on QMS as well as Branch manager. Fulfills the Requirements of Clause No.4

  26. Technical Manager (TM) Responsibility • Preparation &/ Approval of Test SOPs. • Maintenance & calibration of Lab. Equipments. • Allotment of samples to chemist • Preparation of Test Report • Liasioning with external agencies • Signing test report for final approval. Fulfills the Requirements of Clause No.5

  27. Appointment letter of QM & TM

  28. Organization and Management Structure • Its place in parent organization. • Relationship between Quality Management, Technical Operations and Support Services. • Responsibility, authority and interrelationship of all personnel managing, performing, verifying the work affecting in quality of tests/ calibration.

  29. Provide adequate supervision of testing and calibration staff including trainees- • By persons familiar with methods and procedures. • Purpose of each test and/ or calibration • Assessment of the test or calibration results.

  30.  Technical management has the overall responsibility for the technical operations and provision of resources.

  31. Appoint Quality Manager – responsible for - • Ensuring that the management system related to Quality Management is followed all times. • Have access to the highest level of management at which decision are made on Laboratory Policy or resources.

  32. Appoint deputies for key managerial personnel

  33.  Ensure that personnel are aware of their activities and contribution to Management System.

  34. 4.2 Management System 4.2.1 Laboratory shall • Establish • Implement • Maintain Management system as per scope of the activities.

  35. 4.2.1 Lab shall document its • Policies • Procedures • Systems • Programmes • Instructions Necessary to assure the quality of the test / calibration.

  36. 4.2.1 The Systems documentation shall be • Communicated • Understood • Be available • Implemented By concerned persons.

  37. 4.2.2 Quality Policy shall be defined to include • Management’s commitment to good professional practice and to the quality of its testing and calibration in servicing its customers • Managements statement of the Laboratory’s standard of service. • The purpose of management system related to quality. • All personnel concerned with testing and calibration activities with the lab familiar with the quality documentation and implement the policies and procedures in their work.

  38. Comply with this International standard and to continually improve the effectiveness of Management system. • Tests and calibration shall always be carried out as per the stated methods and customers requirements.

  39. Quality Policy A • We are committed for providing quality testing as per ISO 17025 and following best laboratory practices.

  40. Quality Policy B XYZ is committed to carry out reliable, accurate and timely testing related to Clinical Biochemistry, Clinical Pathology & Serology of samples by:- * Following Good Clinical Laboratory practices, complying with IS/ISO 17025:2005 & NABL 104. * Following requirement of national and international standards for testing. * Providing best quality of services to satisfy customer’s requirements. * Creating awareness amongst the staff about established policies and procedures * Providing training to employees to update and enhance their skills, knowledge & competence. * Ensuring effective implementation of Laboratory Management System in day to day activities. * Ensuring proper maintenance and Calibration of equipment. Monitoring, measuring and continually improving the conditions affecting the test. The Policy is communicated to all the employees and is reviewed once in year for its suitability and its effectiveness. Date: Managing Director

  41. 4.2.3 Management Commitment • For development and implementation of Management System. • Continually improving its effectiveness.

  42. 4.2.4 Communicate to the organization the importance of meeting customer requirements. • Importance of meeting statutory and regulatory requirements. • Maintain integrity of Management system when changes are planned and implemented.

  43. Quality Objectives • Quantified monitoring and measurement statements for achieving policy • SMART

  44. Examples – Which are SMART Objectives • Reduce error in sample collection & identification. • Reduce error in transportation and processing. • Generate error free examination report. • Optimize the turnaround time of all examinations. • Attend complaints promptly to enhance customer satisfaction. • Reduce equipment downtime. • Ensure control of Z Score in testing and measurement. • Ensure acceptable performance in External Quality Assessment Scheme. • Enhance skill, competency and knowledge of employees through training.

  45. 4.2.5 Quality Manual • Include or make reference to the supporting procedures including technical procedure. • Include structure of the documentation used in the management system. • Roles and responsibilities of technical management and quality manager. • Responsibilities for ensuring compliance with International Standard.

  46. Document • What is document? • (Exercise mix documents /records-which are documents) • Show cover page of Quality Manual, What do you notice? • How to identify document? • Preparing /reviewing/ approving/issuing • Document changes, how will you carry out? • Controlled/ uncontrolled • External origin document • Document structure. • What is obsolete document? • How will you ensure it is removed from point of use? • How will you distribute documents?

  47. What is document? • Documents may be in any form or type of medium which reflects in terms of information or guideline, • following examples:-         paper (“hard copy”)-         magnetic-         electronic or optical computer disc -         photograph-         master sample

  48. Examples of Documents

  49. Good Document Control • Identification & Traceability • Authorities for Preparation, Review ,Approve & Issue of document • Document Issue, Distribution & Control (To ensure Current document is available at point of Use) • Document Change & Obsolete Control • Control of External Origin Documents • Master List

  50. Identification & Traceability of Document • Name of the company & Logo • Title of document • Identification Number • Issue/ Revision Number • Issue/ Revision Date • Page Control XYZ Ltd., Nagpur Title: APEX MANNUAL Doc.No: XYZ/EnMGR/AML Issue/Rev No: 01/00 Iss/Rev.Date: 01.05.15 Page No: 1 of 2

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