• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Présentation charki-sharebiotech
 

Présentation charki-sharebiotech

on

  • 1,519 views

 

Statistics

Views

Total Views
1,519
Views on SlideShare
1,299
Embed Views
220

Actions

Likes
0
Downloads
50
Comments
0

4 Embeds 220

http://leblogdesqsf-o.blogspot.com 179
http://leblogdesqsf-o.blogspot.fr 35
http://leblogdesqsf-o.blogspot.be 3
http://blogqsfo.wordpress.com 3

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Présentation charki-sharebiotech Présentation charki-sharebiotech Presentation Transcript

    • Management Quality Systems in Life Sciences (ISO/IEC 17025, ISO 15189, etc.) A. Charki University of Angers Abderafi.charki@univ-angers.fr 16th December 2011 / Nantes - France International Days for Biotech Quality Management
    • Pyramid of Conformity Assessmentwww.ilac.orgILAC - International LaboratoryAccreditation Cooperation ILACwww.european-accreditation.org EAEA - European cooperationfor Accreditation Accreditation Bodies Certification Bodies Industries Consumers 26th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Context ? Products, Services, Processus Personal Certification Certification « Label rouge », NF, Food Products, Protected Designation Diagnosis, auditors of quality of Origin (PDO), Organic farming, systems management, etc. International Food Standard (IFS), etc. ISO/IEC 17024ISO/IEC 65NF EN 45011 Quality systems Certification ISO 9001, ISO 14001, ISO 22000, etc. ISO/IEC 17021 36th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Context ? Inspection Bodies Laboratories Food, Health, environment, etc. Food, Health, environment, Testing, calibration, etc.ISO/IEC 17020 ISO/IEC 17025 GPE / GPL ISO 15189 (BML) « Good Practice of Expérimentation (1)»/ « Good Practice of Laboratory(2) » ( 1)(2) Regulation of chemical industry, * Direction Générale de LAB BPE REF 02* (2) Pharmaceutical, comestic l’Alimentation / Sous Directive 91/414/CEE, and veterinary products Directive 2004/10/CE Direction de la Qualité et de la Protection des Végétaux http://www.cofrac.fr 46th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Case of Laboratories Focus on accreditation according to ISO/IEC 17025 and ISO 15189 Suitable Management Systems for Life Sciences 56th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • ISO/IEC 17025 and ISO 15189 66th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • CASCO Communiqué http://www.iso.org “A medical laboratorys fulfilment of the requirements of ISO 15189 : 2007 means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid test results. The management system requirements in ISO 15189 (Section 4) are written in a language relevant to a medical laboratories operations and meet the principles of ISO 9001:2008 Quality management systems - Requirements and are aligned with it pertinent requirements.” September 2009 76th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • CASCO Communiqué http://www.iso.org “A laboratorys fulfilment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results and calibrations. The management system requirements in ISO/IEC 17025:2005 (Section 4) are written in language relevant to laboratory operations and meet the principles of ISO 9001:2008 Quality Management Systems — Requirements and are aligned with its pertinent requirements.” January 2009 86th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation of a laboratory : A good challenge! What is « accreditation »? Important steps in preparing for the accreditation process : • quality management requirements • and technical requirements An overview during the full assessment (ISO 15189 as example) of Managment Quality System 96th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? Accreditation is not certification and inspection ! Accreditation means that evaluators i.e. testing and calibration laboratories, certification and inspection bodies have been assessed against internationally recognized standards to demonstrate their competence, impartiality and performance capability. Certification and inspection bodies cannot use the ISO/IEC 17025 ISO 15189, ISO 45011 , ISO/IEC 17020, ISO/IEC 17021 and ISO/IEC 17024 standards 106th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? Not all laboratories are the sameMedical A laboratory of many integrated procedures Community intended for diagnosis, confirmation, Hospital documentation of human health information Public HealthTesting A laboratory of limited stand-alone Manufacturing procedures intended to confirm conformity Electrical of a product to its expected target or goal Water Food Public HealthCalibration A laboratory of a very limited range of All industries, testing procedures intended to ensure traceability and other laboratories of equipment or material to highest level (Reference) possible. 116th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? How do accreditation bodies evaluate the competence of accredited laboratories? On-site evaluation to the requirements of ISO/IEC 17025 and ISO 15189 Only accreditation bodies can use the ISO/IEC 17025 and ISO 15189 standards www.ilac.org ILAC - International Laboratory Accreditation Cooperation www.european-accreditation.org EA - European cooperation for Accreditation 126th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • COFRAC ? As an organization which is mandated by public authorities, COFRAC = Comité français d’accréditation (the French accreditation committee) is officially recognized as national accreditation body. 136th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • COFRAC ?Cofrac has been designated as the sole national accreditation bodyby the Decree of 19 December 2008,thus recognizing accreditation as a public authority activity.Cofrac’s mission is to prove the skills and perfectorganization of conformity assessment bodies: laboratories,certification bodies and inspection bodies.Cofrac, a non-profit association under the law of July 1901, wascreated in 1994. All interested parties are represented withinits governing bodies (Board of Administrators and Section’scommittees): accredited bodies, professional groupings andcompanies, major associations of purchasers and consumersand public authorities. 146th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • COFRAC ?Accreditation goes further than ISO 9001 certification byproviding more than just recognition that a quality systemcomplies with a reference guide or standard. It providesrecognition the reliability of their results and of the skills,especially the technical skills, of the personnelorganization concerned by using quality assessors,assessors and technical experts. 156th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • COFRAC ? 166th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • COFRAC ? Case 1 Case 2 Case 3 Certified Quality System Accredited Quality and Technical System Accredited Quality System Case 4 Case 4 176th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? Laboratory types concerned ?Main Laboratory: A laboratory (organization) that maintains a single location onlyPermanent Laboratory: A laboratory erected on a fixed location. This is thelaboratory location (address) denoted on the scope of accreditationBranch Laboratory [multi-location system]: A laboratory system that consists oftwo or more laboratories owned and operated by the same organization, utilizingthe same management systemMobile Laboratory: Fully equipped, self-contained, transportable testing orcalibration laboratory capable of performing tests or calibrations undercontrolled environmental conditions. Mobile laboratories are subject to the sameterms of accreditation as a field laboratory 186th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? What do you essentially need for accreditation? • Scope of accreditation : proposed scope of testing or calibration in terms of field(s) of testing or calibration, testing or calibration technologies, methods and relevant standards, and measurement uncertainty budgets if applicable (always required for calibration); • Organization structure; • Technical competence of the personnal of laboratory; • Reliability of measurement (equipments, methods and laboratory environment checked, validated, adapted to the activities,…); • Proficiency testing results. 196th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? Scope of accreditation? 206th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Accreditation? Scope of accreditation?For tests, the scope of accreditation is normally identified in termsof standard test methods prepared by national, international, andprofessional standards writing bodies.If a laboratory wishes accreditation for the use of its ownmethods (good for research), then it must provide thefollowing information to the assessor(s) before assessment:- Origin of method;- Comparison with the standard methods they replaceincluding any departures from the standard (if applicable);- Reasons for and effects;- Validation data (per Section 5.4.5 of ISO/IEC 17025). 216th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Quality Management Part• Ensure the competence of persons of the laboratory (training, capability,experiments, ...)•Create and implement a Quality Manual and Management System policies andprocedures that meets ISO/IEC 17025:2005 or ISO 15189 requirements andaccreditation body requirements as well .•Perform a self-assessment (internal audit) to verify compliance with allrequirements, standards and the laboratory’s own management system andapplicable test or calibration methods and document the results.It is important to seek feedback from all the applicable individuals to get the mostcomprehensive evaluation of the organization.•Perform a management review in accordance with section 4.2.2 and 4.15 of ISO/IEC17025 and document the results. 22 6th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Quality Management Part• Identify an individual to assume responsibility of upholding the accreditation requirements and make available the relevant resources.• Identify the person in charge of the management system (e.g., the Quality Manager).An effective management system functions as such with the supportand commitment from the top management (as required in ISO/IEC17025). In a large organization, the coordination of these activities maybe too large a task for the top manager and it is imperative that theindividual(s) decide how to handle this important subsidiary function.Top management may need assistance from an individual(s) who wouldbe responsible for the development and maintenance of thedocumented quality system. 236th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Quality Management Part The laboratory should ensure that there are records demonstrating compliance with all of the Quality Management System (QMS). The QMS includes: Organization and Management, Document Control. Contracting, Services and Supplies, Customer Feedback, Nonconformance, Corrective and Preventive actions, Continuous Improvement, Quality and technical records, Internal Audits, Management Reviews, Personnel Qualifications, Responsibilities, training and competency, Accommodations and Environment, Laboratory Equipment System, Measurement Traceability Methods validation Pre-examination, examination and post-examination procedures (ISO 15189) Result reporting 246th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Technical Part All calibrations and verifications of measuring and test equipment and reference standards, be conducted by: - a calibration laboratory accredited to ISO/IEC 17025 by a mutually recognized Accreditation Body; - or a recognized National Metrology Institute (NMI) including designated institutes. Recognition of the NMI is based on the Institute or designated institute being a signatory to the CIPM (Comité International des Poids et Mesures) MRA (Mutual Recognition Arrangement) and supporting the measurement comparison activities of the CIPM. A listing of these recognized Institutes can be found at http://www.bipm.org/en/cipm-mra/participation/signatories.html 256th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • 266th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Technical Part The in-house laboratory must have and apply procedures for evaluating measurement uncertainty. An in-house calibration system ensures that all measuring and test equipment used in a company is calibrated regularly against its own reference standards. The in-house calibration system shall ensure traceability of measurement by having its reference standards calibrated at an accredited calibration laboratory or a national metrology institute. 276th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Technical Part Proficiency testing is a process for checking actual laboratory testing performance, usually by means of interlaboratory test data comparisons. For many tests and calibrations, results from proficiency testing are very good indicators of competence. Proficiency testing programs may take many forms and standards for satisfactory performance can vary depending on the field. 286th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Technical PartDEFINITIONS (refer ISO/IEC Guide 43-1)(laboratory) proficiency testing: -“determination of laboratory testing performance by means ofinterlaboratory comparisons” The aim is to test the laboratory’s ability to calibrateequipment within its claimed accuracy Secondary aims: TEST ITEM Reference value assigned by the coordinating laboratory- interpret documentary standards LAB 1 LAB 2 LAB 3 LAB N- calculating results and uncertainties N 2- reporting the results Ref Value 1 3 = Uncertainty Range 296th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • Important steps in preparing for the accreditation : Technical PartThe laboratory must also be able to explain when proficiency testing isnot possible for certain testing and this explanation must be included inthe plan.When inter-laboratory comparisons (ILCs) are not available or relevantto the scope of accreditation, internal performance-based data inaccordance with clause 5.9 of ISO/IEC 17025 are acceptable.Internal performance-based checks (or data or evaluations) include (butare not limited to) the following types of activities: regular use ofcertified reference materials and/or internal quality control usingsecondary reference materials; replicate tests or calibrations using thesame or different methods; retesting or re-calibration of retained items;and correlation of results for different characteristics of an item. 306th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment The full assessment generally involves: - An entry briefing with laboratory management; - Interviews with also technical staff; - Demonstration of selected tests or calibrations including, as applicable, tests or calibrations at representative field locations; - Examination of equipment and calibration records; - Audit of the management system to verify that it is fully operational and that it conforms to all sections of ISO/IEC 17025 or ISO 15189, including documentation; - Evaluation of your laboratory’s compliance with the accreditation body requirements documents (Policy on Estimating Measurement Uncertainty for Testing Laboratories, on Proficiency Testing for ISO/IEC 17025 Laboratories, etc.); - A written report of assessor findings; - An exit briefing including the specific written identification of any deficiencies. 316th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessmentDuring the assessment, assessors may observe deficiencies. Adeficiency is any nonconformity to accreditation requirementsincluding:- a laboratory’s inability to perform a test, type of test, orcalibration for which it seeks accreditation;- a laboratory’s management system does not conform to a clauseor section of ISO/IEC 17025 or ISO 15189, is not adequatelydocumented, or is not completely implemented in accordancewith that documentation;- a laboratory does not conform to any additional requirements ofthe accreditation body or specific fields of testing or programsnecessary to meet particular needs. 326th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example ISO 15189:2007 Medical Laboratories – particular requirements for quality and competence. 336th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Management Requirements Technical Requirements 1. Organization 1. Personnel 2. Quality Management System 2. Accommodation / environment 3. Document Control 3. Laboratory Equipment 4. Review of Contracts 4. Pre-examination procedures 5. Referral Laboratories 5. Examination procedures 6. External Services and Supplies 6. Assuring quality of examinations 7. Identification and control of 7. Post-examination procedures non-conformities 8. Reporting Results 8. Corrective Actions 9. Preventive Actions 10. Continual Improvement 11. Quality and Technical Records 12. Internal Audits 13. Management Review 346th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • Organization – A medical laboratory shall be a legal entity. – Medical laboratories shall be designed to meet patient needs. – Laboratory personnel responsibilities shall be defined. – Laboratory management shall provide personnel with the resources and authority to perform their duties. – Laboratory policies and procedures shall protect confidential information. – The laboratory shall appoint a quality manager. – The laboratory shall have technical management for overall responsibility of technical operations and the provision of resources needed to ensure the required quality of laboratory procedures. 356th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • The laboratory shall be directed by a person or persons having executive responsibility and the competence to assume responsibility for the services provided. (note: competence is the product of basic, academic, postgraduate, continuing education, and training and experience of several years in a medical laboratory). • The laboratory director shall be responsible for professional, scientific, consultative or advisory organization, administrative and educational matters. • The laboratory director need not perform all responsibilities personally. However it is the laboratory director who remains responsible for the overall operation and administration of the laboratory, for ensuring quality services provided for patients. 366th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • Laboratory management shall review the laboratory’s quality management system and all of its medical services, including examination and advisory activities to ensure their continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements. • The results of the review shall be incorporated into a plan that includes goals, objectives and action plans. • The typical period for conducting a management review is once every twelve months. • Management review shall take into account, follow-up of previous review, status of corrective actions, reports from managers and supervisors, internal audits, assessments of external bodies, quality indicators, feedback (complaints), non-conformities, continual improvement processes, evaluation of suppliers. 376th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • Laboratory management shall have an organization plan, personnel policies and job descriptions that define qualifications and duties for all personnel. • Laboratory management shall authorize personnel to perform particular tasks. • Personnel shall have training specific to quality assurance and quality management for services offered. • There shall be a continuing education program available to staff at all levels. • Employees shall be trained to prevent or contain the effects of adverse incidents. • The competency of each person to perform assigned tasks shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary. 386th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • The laboratory shall appoint a quality manager with delegated responsibility and authority to oversee compliance with the requirements of the quality management system. • The quality manager shall report directly to the level of laboratory management at which decisions are made on laboratory policy and resources. • The quality manager shall plan, organize and conduct internal audits. 396th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • The laboratory shall design internal quality control. • It is important that the control system provide staff with clear and easily understood information. • The laboratory shall determine the uncertainty of results where relevant and possible. • A programme for calibration of measuring systems and verification of trueness shall be designed and performed so as to ensure that results are traceable to SI units • The laboratory shall participate in a suitable inter-laboratory comparison. • The laboratory shall use suitable reference materials, certified to indicate the characterization of the material. • For those examinations performed using different procedures or equipment at different sites, there shall be a defined mechanism for verifying the comparability of results throughout the clinically appropriate intervals. 406th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements • Internal audits shall address all elements of the system, both management and technical, and emphasize areas critically important to patient care. • Audits shall be planned, organized and carried out by the quality manager • Procedures of the audits shall be documented and carried out within an agreed upon time. • The main elements of the quality system should be subject to internal audit once every 12 months. • The results of internal audits shall be submitted to laboratory management for review. 416th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Continuous Improvement Let’s see some requirements • Laboratory management shall have a policy and procedure to be implemented when it detects that any aspect of its examinations does not conform with its own procedures or the agreed upon requirements of the quality management system, or the requesting physician. • Procedures for corrective action shall include an investigative process to determine the underlying cause or causes of the problem. • Corrective action shall be appropriate to the magnitude of the problem and commensurate with the risk. • These shall lead, where appropriate to preventive actions. 426th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Let’s see some requirements …. • All operational procedures shall be systematically reviewed by laboratory management at regular intervals in order to identify potential sources of non-conformance. • Action plans for improvement shall be developed, documented and implemented. • After the action has been implemented, management shall evaluate the effectiveness of the action. • Management shall implement quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care. • When opportunities for improvement are detected, management shall address them regardless of where they occur. 436th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr
    • During the full assessment ISO 15189 as example Don’t forget ! Establish Mechanisms of Detection Investigate for: Impact – Underlying Cause - Risk REMEDIAL CORRECTIVE PREVENTIVE EVALUATE EFFECTIVENESS MANAGEMENT REVIEW 446th December 2011 / Nantes - France International Days for Biotech Quality Management Abderafi.charki@univ-angers.fr