Quality Assurance International standards (ISO/CLSI) Susanne Karlsmose DTU Food, Denmark
|
|
- Isabel Davis
- 5 years ago
- Views:
Transcription
1 Quality Assurance International standards (ISO/CLSI) Susanne Karlsmose DTU Food, Denmark
2 Definition A quality management system can be defined as: Coordinated activities to direct and control an organization with regard to quality - ISO and CLSI defintion DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
3 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 3 3 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
4 Scope of ISO General requirements for competence tests calibrations sampling to confirm or recognize competence testing / calibration laboratories Quality Administrative Technical systems Does not cover compliance with regulatory and safety requirements for laboratory operations Assessment: 4 DTU Food, Norms Technical University and of Accreditation-Module Denmark 4
5 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 5 5 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
6 Scope of ISO Based on ISO 17025:1999 & 9001:2000 Medical Laboratory Particular requirements for quality & competence to confirm or recognize competence Laboratory quality management Technical processes Quality Administrative Technical systems 6 DTU Food, Technical University of Denmark Assessment: Norms and Accreditation-Module
7 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 7 7 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
8 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 8 8 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
9 Standardization Bodies International organizations include: ISO CLSI CEN WHO Assessment: Norms and Accreditation-Module 9 DTU Food, Technical University of Denmark 11 9
10 International Organization for Standardization world's largest developer and publisher of international standards standards are applicable to many kinds of organizations including clinical and public health laboratories Uses consensus process in developing standards Assessment: Norms and Accreditation-Module 10 DTU Food, Technical University of Denmark 11 10
11 Clinical and Laboratory Standards Institute global, nonprofit, standards-developing organization detailed; standards apply specifically to medical laboratories promotes the development and use of voluntary consensus standards and guidelines documents are developed by experts working on subcommittees or working groups (consensus process) Assessment: Norms and Accreditation-Module 11 DTU Food, Technical University of Denmark 11 11
12 European Committee for Standardization founded by the national standards bodies in the European Economic Community and associated countries general terms include openness and transparency, consensus, and integration Assessment: Norms and Accreditation-Module 12 DTU Food, Technical University of Denmark 11 12
13 World Health Organization has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles Assessment: Norms and Accreditation-Module 13 DTU Food, Technical University of Denmark 11 13
14 Self-developed standards Many agencies, organizations, or regions develop their own accreditation requirements rather than using internationally recognized standards. Advantages: optimized for local use, recognized local strengths and weaknesses can be developed in progressive steps can lead to full international recognition Weaknesses: may be narrow or biased may not be recognized by other organizations Assessment: Norms and Accreditation-Module 14 DTU Food, Technical University of Denmark 11 14
15 To assure quality Def.: Coordinated activities to direct and control an organization with regard to quality A quality management system includes all aspects of the laboratory operation, i.e.: Organizational structure Processes Procedures The entire process of managing a sample must be considered: sample collection reporting and saving of results all processes in between DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
16 Organization Personnel Equipment Purchasing & Inventory Documents & Records Process Control Occurrence Management Information Management Assessment Twelve Quality System Essentials Quality management system model developed by CLSI (QMS01-A4) (and is fully compatible with ISO standards) Process Improvement Customer Service Facilities & Safety DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
17 Organization Personnel Equipment Purchasing & Inventory Documents & Records Process Control Occurrence Management Information Management Assessment Twelve Quality System Essentials Set of coordinated activities that function as building blocks for quality management Process Improvement Customer Service Facilities & Safety Management commitment is crucial! DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
18 Responsibilities Laboratory Director implements international or national standards seeks information about appropriate norms and standards seeks information about accreditation and certification processes uses outcomes to provide better service Technician aware of requirements contributes to meeting standards aware of assessment processes helps prepare for assessment Assessment: Norms and Accreditation-Module DTU Food, Technical University of Denmark Quality Manager explains the process for meeting standards to staff organizes the laboratory in preparation for assessments 18
19 Standardization Standardized and quality assured methods Reliable and reproducible data DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
20 Standards/guidelines International standards describe the methods (DD and MIC) in detail: media, inoculum, incubation, etc. Standards: - ISO documents - Some CLSI documents (approved standard) Guidelines: - Some CLSI documents (approved guideline) - EUCAST (The European Committee on Antimicrobial Susceptibility Testing DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
21 Standardization our world All AST methods are extremely sensitive to variations Factors that influence the result of AST: - Size of inoculum - Contents and acidity (ph) of the broth or agar - Incubation time and temperature - Reading procedures Moreover, for the diffusion methods: - Diffusion rate of the antimicrobial into the agar - Depth of the agar - Dryness of the agar - Growth rate of the bacteria DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark
22 Personnel human resources job qualifications job descriptions training competency assessment professional development continuing education 22 Introduction DTU Food, Technical Laboratory University of Denmark Quality Management 22
23 Equipment Monitor temperatures of: incubators refrigerators freezers Perform function checks for: pipettes autoclaves ph meter weights and measures Maintain records Management assures: Responsibility assigned Relevant training of personnel 23 DTU Food, Technical University of Denmark 23
24 Occurrence Management complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions 24 DTU Food, Technical University of Denmark 24
25 What went wrong? The organism was misidentified A typo/clerical error was made Switch of strains/samples The wrong test was ordered The sample was not preserved properly Contamination Growth Inoculation Incubation Media Etc 25 QC Antimicrobial DTU Food, Technical University Susceptibility of Denmark Testing - Module 8 25
26 Laboratory Assessment Internal External Proficiency testing (EQA) Inspections Accreditations 26 DTU Food, Technical University of Denmark 26
27 Questions arise Does the laboratory need certification/ accreditation? Which standards should the laboratory use? Which regulation is relevant? Assessment: Norms and Accreditation-Module 27 DTU Food, Technical University of Denmark 11 27
28 Definitions Certification (ISO/IEC 17000) Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements. Examples of certification standards: - ISO 9001: ISO Accreditation (ISO 15189) Procedure by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks. Examples of accreditation standards: - ISO ISO Assessment: Norms and Accreditation-Module 28 DTU Food, Technical University of Denmark 11 28
29 Approved Knowledgeable Competent staff Certification and Accreditation Bodies Standardsbased Objective Assessment: Norms and Accreditation-Module 29 DTU Food, Technical University of Denmark 11 29
30 Accreditation outcomes strength and integrity of the quality system are measured continual monitoring of the quality system recognition for efforts recognition as delivering accurate and reproducible results recognition of compliance with the quality standards and norms used for the assessment Awarded to Quality Lab 2013 Assessment: Norms and Accreditation-Module 30 DTU Food, Technical University of Denmark 11 30
31 Also, accredited labs tend to - perform better on proficiency testing - are more likely to have a working quality management system BUT 31 Accreditation does not guarantee success, it is only one step along the quality journey Continual improvement is necessary! Assessment: Norms and Accreditation-Module 31 DTU Food, Technical University of Denmark 11
32 Summary Standards form the basis for quality practices. They are developed by organizations. A method standard is a method standard. If modified, the standard was not followed. Method guidelines may be adjusted/modified. Accreditation and certification are processes that recognize that a laboratory meets the designated standards. Accreditation is an important step in the continual improvement of the quality management system. Assessment: Norms and Accreditation-Module 32 Assessment: DTU Food, Technical Norms University and Accreditation-Module of Denmark
33 Implementing Quality Management does not guarantee an ERROR-FREE Laboratory But it detects errors that may occur and prevents them from recurring 33 Introduction DTU Food, Technical Laboratory University of Denmark Quality Management 33
34 Laboratories not implementing a quality management system guarantees UNDETECTED ERRORS 34 DTU Food, Technical University of Denmark
35 Ref.: and further information, see: Thanks for your attention! 35 DTU Food, Technical University of Denmark 35
Accreditation Bodies in other
Accreditation Bodies in other WHO Regions Jeanette Twell 6July2011 Overview ILAC Accreditation International Standards vs Guidance Auditing (NATA) EQAS/Proficiency Testing Take home message 2 International
More informationISO/IEC Accreditation: The Big Picture and Getting Started
ISO/IEC 17025 Accreditation: The Big Picture and Getting Started John Szpylka, Ph.D. Scientific Affaires Director, Chemistry N.A. AAFCO 2017 Midyear Meeting Takeaways Accreditation versus Certification
More informationLaboratory Accreditation Building Confidence on Testing Quality
Laboratory Accreditation Building Confidence on Testing Quality Dr. George Anastasopoulos, Director (Conformity Assessment) & Prasanth S Ramakrishnan, MS, LEED-AP (Principal Staff & Program Manager) ASME
More informationBetter Regulatory Outcomes & the CASCO Toolbox
2011/SOM1/SCSC/CON1/013 Session 8 Better Regulatory Outcomes & the CASCO Toolbox Submitted by: Underwriters Laboratories 6 th Conference on Good Regulatory Practice Washington, D.C., United States 1-2
More informationACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES ACCREDITATION SCHEME MANUAL Document Title: Document Number: Various Accreditation Schemes ACCAB-ASM-7.0 CONTROLLED COPY Revision Number Revision
More informationACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES ACCREDITATION SCHEME MANUAL Document Title: Document Number: Various Accreditation Schemes ACCAB-ASM-7.0 CONTROLLED COPY Revision Number Revision
More informationNATIONAL COMMISSION ON FORENSIC SCIENCE
NATIONAL COMMISSION ON FORENSIC SCIENCE Recommendation for the Accreditation of Digital and Multimedia Forensic Science Service Providers 1 Subcommittee Date of Current Version 25/02/16 Accreditation and
More informationACCAB. Accreditation Commission For Conformity Assessment Bodies
ACCAB Accreditation Commission For Conformity Assessment Bodies ACCAB Platinum Plus Accreditation For Certification Bodies, Inspection Bodies, Testing & Calibration Laboratories and Medical Laboratories
More informationOverview of conformity assessment programs and ASTM International s related activities
Overview of conformity assessment programs and ASTM International s related activities African Organization for Standardization 21 June 2016 Tim Brooke Vice President Certification Training, and Proficiency
More informationAccreditation: Assuring Competence
Accreditation: Assuring Competence Outline Background of SAC SAC Accreditation Programmes Accreditation Process What is conformity assessment? What is accreditation? Proof of Accreditation Benefits of
More informationEOQ personal certificates
EOQ personal certificates The European Organization for Quality (EOQ) has introduced an umbrella organization of national quality associations of all European countries a scheme for the qualification,
More informationFrequently Asked Questions
Frequently Asked Questions ISO 15189 Accreditation Program cap.org Contents ISO and the International Organization for Standardization What does ISO stand for? (page 3) What is the International Organization
More informationACCAB. Accreditation Commission For Conformity Assessment Bodies
ACCAB Accreditation Commission For Conformity Assessment Bodies ACCAB Platinum Plus Accreditation For Certification Bodies, Inspection Bodies, Testing & Calibration Laboratories and Medical Laboratories
More informationPRESENTATION OVERVIEW
ITU Regional Seminar for the Africa Region on Conformance and Interoperability Testing Centre(s) Accra (Ghana), 4-6 July 2011 Accreditation Bodies Presented by Andrew Kwan ITU Consultant 1 PRESENTATION
More informationIntroduction to UKAS Accreditation Fire Scene Development Programme. David Compton November 2017
Introduction to UKAS Accreditation Fire Scene Development Programme David Compton November 2017 What is UKAS Accreditation? Procedure by which an authoritative body gives formal recognition that a body
More informationMODULE B - PROCESS SUBMODULES B1.
Slide 1 MODULE B - PROCESS SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects
More informationIAS Accreditation Overview. Mark Johnson, ICC
IAS Accreditation Overview Mark Johnson, ICC What We Will Cover IAS Background Overview of IAS Programs IAS Accreditation and Building Codes IAS Laboratory Accreditation Program 2 About IAS: Company Profile
More informationInternational Laboratory Accreditation Cooperation. The ILAC Mutual Recognition Arrangement. global trust. Testing Calibration Inspection
International Laboratory Accreditation Cooperation The ILAC Mutual Recognition Arrangement Enhancing the acceptance of products and services across national borders Removing barriers to global trade Accreditation
More informationFORENSIC LABORATORY DEVELOPMENT AND MANAGEMENT: INTERNATIONAL BEST PRACTICES BY AGWEYE, BENEDICT HEAD OF FORENSICS, EFCC
FORENSIC LABORATORY DEVELOPMENT AND MANAGEMENT: INTERNATIONAL BEST PRACTICES BY AGWEYE, BENEDICT HEAD OF FORENSICS, EFCC DISCLAIMER THIS PAPER IS NOT A LEGAL ADVISE OR OPINION IT DOES NOT SPEAK FOR OR
More informationTURKISH ACCREDITATION AGENCY. Training, Promotion and Information Directorate
TURKISH ACCREDITATION AGENCY Training, Promotion and Information Directorate About us... Main field of activity of the Training, Promotion and Information Directorate (TPID) is organizing the training
More informationGlobal Wind Organisation CRITERIA FOR THE CERTIFICATION BODY
Global Wind Organisation CRITERIA FOR THE CERTIFICATION BODY December 2015 (Version 3) 1 Contents 1. Introduction... 5 2. Criteria for approval of a Certification Body... 5 3. Selection of audit team members
More informationPROTERRA CERTIFICATION PROTOCOL V2.2
PROTERRA CERTIFICATION PROTOCOL V2.2 TABLE OF CONTENTS 1. Introduction 2. Scope of this document 3. Definitions and Abbreviations 4. Approval procedure for Certification Bodies 5. Certification Requirements
More informationISO Certification For Laboratory Accreditation. Dr Amadou TALL Consultation
ISO 17025 Certification For Laboratory Accreditation Dr Amadou TALL Consultation ISO 17025 Certification ISO/IEC 17025 Global quality standard for testing and calibration laboratories. It is the basis
More informationA COMPARISON OF TNI s ACCREDITATION STANDARD TO
A COMPARISON OF TNI s ACCREDITATION STANDARD TO ISO/IEC 17025 WHO IS TNI? A 501(c)3 non-profit organization. A member organization managed by a Board of Directors. A voluntary consensus standards development
More informationISO 9001 Auditing Practices Group Guidance on:
International Organization for Standardization International Accreditation Forum Date: 13 January 2016 ISO 9001 Auditing Practices Group Guidance on: Expected Outcomes The expected outcomes documents (given
More informationAquaculture Certification
Aquaculture Certification Rohana Subasinghe FAO, Rome Aquaculture Certification Guidelines Fifth Session of the COFI/AQ (2010):... the Sub-Committee adopted the draft guidelines and requested the Committee
More informationAccreditation of Forensic Science Service Providers
Accreditation of Forensic Science Service Providers Laurel J Farrell Senior Accreditation Manager ANSI-ASQ National Accreditation Board Quality Matters Topics Accreditation what it is and what it is not
More informationThe Role of SANAS in Support of South African Regulatory Objectives. Mr. Mpho Phaloane South African National Accreditation System
The Role of SANAS in Support of South African Regulatory Objectives Mr. Mpho Phaloane South African National Accreditation System Outline of Presentation INTRODUCTION STATUS OF SANAS TECHNICAL INFRASTRUCTURE
More informationPRODUCT CERTIFICATION SCHEME FOR METROLOGY SYSTEM
Ref No: RACS/PCS/20 Page 1 of 8 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) that Metrology System
More informationPRODUCT CERTIFICATION SCHEME FOR ENERGY DRINKS
Ref No: RACS/PCS/11 Page 1 of 6 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) that Energy Drinks
More informationACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES. Advisory Document on Tenders For Systems, Processes & Product Certifications
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES CAB Accreditation Advisory Document Document Title: Document Number: Advisory Document on Tenders For Systems, Processes & Product Certifications
More informationITU Asia-Pacific Centres of Excellence Training on Conformity and Interoperability. Session 2: Conformity Assessment Principles
ITU Asia-Pacific Centres of Excellence Training on Conformity and Interoperability Session 2: Conformity Assessment Principles 12-16 October 2015 Beijing, China Keith Mainwaring ITU Expert Agenda 1. Context
More informationConference for Food Protection. Standards for Accreditation of Food Protection Manager Certification Programs. Frequently Asked Questions
Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs Frequently Asked Questions Q. What was the primary purpose for the Conference for Food Protection
More informationMaster degree program Technical legislation, standardization and quality management
The experience of the Technical University of Sofia in education about standardization Master degree program Technical legislation, standardization and quality management Opened in 2007 at the Faculty
More informationPersonnel Certification
Personnel Certification Facilitating the Growth of a Global Economy Roy A. Swift, Ph.D. Senior Director, Personnel Credentialing Accreditation Programs American National Standards Institute Building a
More informationConformity Assessment Schemes and Interoperability Testing (1) Keith Mainwaring ITU Telecommunication Standardization Bureau (TSB) Consultant
Conformity Assessment Schemes and Interoperability Testing (1) Keith Mainwaring ITU Standardization Bureau (TSB) Consultant Moscow, 9-11 november 2011 Contents The benefits of conformity assessment Conformity
More informationKENYA ACCREDITATION SERVICE
KENAS-GUD-010 01 22/06/2013 22/07/2013 GUD 1 of 9 Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this Document. Name Job Title / Role Signature
More informationAccreditation Body Evaluation Procedure for AASHTO R18 Accreditation
Accreditation Body Evaluation Procedure for AASHTO R18 Accreditation Final August 9, 2016 Page 1 of 12 Section Number Table of Contents Title of Section 0 Purpose 1 Scope 2 References 3 Objectives 4 Criteria
More informationEUROPEAN ACCREDITATION LEGAL FRAMEWORK
EUROPEAN ACCREDITATION LEGAL FRAMEWORK ECIBC Plenary 2016 Ed Wieles 24 November 2016 CONTENTS European model on Accreditation Requirements for Accreditation bodies Harmonised standards for accreditation
More informationVaccine data collection tool Oct Functions, Indicators & Sub-Indicators
data collection tool Oct. 2011 A. National Regulatory System RS01: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function RS01.01: Legislation or and
More informationIntroduction to Conformity Assessment and ISO/CASCO Tool Box
www.aeconformity.com Introduction to Conformity Assessment and ISO/CASCO Tool Box Alex Ezrakhovich Co-convener of APG & AAPG Sydney, Australia 5th International Conference on Quality Management October
More informationDAkkS Who we are. Attesting competence, Assuring quality, Creating confidence.
DAkkS Who we are Attesting competence, Assuring quality, Creating confidence. What is accreditation? Reliability through conformity assessment The demands on the quality of goods and services are growing
More informationWorkshop Item 1 - ISO 9001: 2008 migration
Workshop Item 1 - ISO 9001: 2008 migration Joint IAF-ISO Communiqué on migration to ISO 9001: 2008 ISO 9001: 2008 does not contain any new requirements Accredited Certification to ISO 9001:2008 shall not
More informationSPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF FOOD SAFETY MANAGEMENT SYSTEMS
BELAC 2-405-FSMS Rev 1-2017 SPECIFIC PROVISIONS FOR THE ACCREDITATION OF CERTIFICATION BODIES IN THE FIELD OF FOOD SAFETY MANAGEMENT SYSTEMS The only valid versions of the documents of the BELAC management
More informationPRODUCT CERTIFICATION SCHEME FOR MILK AND DAIRY PRODUCTS
Ref No: RACS/PCS/16 Page 1 of 8 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) to assure that Milk
More informationIMPLEMENTATION COURSE (MODULE 1) (ISO 9001:2008 AVAILABLE ON REQUEST)
ISO 9001:2015 IMPLEMENTATION COURSE (MODULE 1) (ISO 9001:2008 AVAILABLE ON REQUEST) COURSE DURATION: 3 DAYS Course Summary: The implementation course provides the participant with an in-depth level of
More informationNational Cooperation for Laboratory Accreditation Annual General Meeting International versus National Recognition: A Comparison
National Cooperation for Laboratory Accreditation Annual General Meeting International versus National Recognition: A Comparison August 2011 1 Purpose of International Recognition Simply put, the purpose
More informationThe International Laboratory Accreditation Cooperation (ILAC) & The International Accreditation Forum (IAF)
The International Laboratory Accreditation Cooperation (ILAC) & The International Accreditation Forum (IAF) Perspectives on ILAC & IAF Multilateral Mutual Recognition Arrangements Peter Unger, ILAC Chair
More informationLaboratory Setup vis-a-vis NABL ACCREDITATION
Laboratory Setup vis-a-vis NABL ACCREDITATION National Accreditation Board For Testing and Calibration Laboratories (NABL) An Autonomous body under the aegis of Department of Science & Technology, Government
More informationInternational Accreditation Forum, Inc. User Advisory Committee UAC
International Accreditation Forum, Inc. User Advisory Committee UAC UAC Position Paper UAC- N018 Users Expectations of Accreditation, of the Multilateral Recognition Arrangement (MLA) between Accreditation
More informationPart 5: Requirements for ABs FOOD SAFETY SYSTEM CERTIFICATION Part V: Requirements for Accreditation Bodies
Part 5: Requirements for ABs FOOD SAFETY SYSTEM CERTIFICATION 22000 Part V: Requirements for Accreditation Bodies Version 4.1: July 2017 Part V: Requirements for Accreditation Bodies Contents 1 Purpose...
More informationReport of analysis of training programs in the field of QMS from EU partners - POLAND
Improvement of Partnership with Enterprises by Enhancement of a Regional Quality Management Potentials in WBC University of Montenegro, Cetinjska 2, 81000 Podgorica, Montenegro www.ucg.ac.me e-mail: rektorat@ac.me,
More informationWhen Recognition Matters WHITEPAPER ISO SUPPLY CHAIN SECURITY MANAGEMENT SYSTEMS.
When Recognition Matters WHITEPAPER ISO 28000 SUPPLY CHAIN SECURITY MANAGEMENT SYSTEMS www.pecb.com CONTENT 3 4 4 4 4 5 6 6 7 7 7 8 9 10 11 12 Introduction An overview of ISO 28000:2007 Key clauses of
More informationProcess for the Evaluation and Acceptance of Building Products in the USA
Process for the Evaluation and Acceptance of Building Products in the USA Rick Okawa, P.E. Deputy Vice President of Global Services and Business Development An Integrated Building System Product Certification
More informationISO/IEC INTERNATIONAL STANDARD. General requirements for the competence of testing and calibration laboratories
INTERNATIONAL STANDARD ISO/IEC 17025 Second edition 2005-05-15 General requirements for the competence of testing and calibration laboratories Exigences générales concernant la compétence des laboratoires
More informationInspection and Certification for Individual Farms, Smallholder Group Certification S S R A N A S R S C I E N T I S T
Inspection and Certification for Individual Farms, Smallholder Group Certification S S R A N A S R S C I E N T I S T What is Certification? Organic certification system is a quality assurance initiative,
More informationGUIDELINE. of the European Committee for Welding of Railway Vehicles (ECWRV) ( ) PART 1
GUIDELINE of the European Committee for Welding of Railway Vehicles (ECWRV) (2016-05-10) PART 1 Procedure for the application of EN 15085 and certification of welding manufacturers for welding railway
More informationIVDR Breakout. Copyright 2017 BSI. All rights reserved.
IVDR Breakout 1 IVDR Classification and conformity assessment 2 Classification- IVDR 3 Classification of IVDs Re-classification of IVDs will mean 80-90 % will no longer be able to self certify conformity
More informationR103 - GENERAL REQUIREMENTS: PROFICIENCY TESTING FOR ISO/IEC LABORATORIES
Page 1 of 8 R103 - GENERAL REQUIREMENTS: PROFICIENCY TESTING FOR ISO/IEC 17025 2018 2018 by A2LA All rights reserved. No part of this document may be reproduced in any form or by any means without the
More informationACCREDITATION: A BRIEFING FOR GOVERNMENTS AND REGULATORS
ACCREDITATION: A BRIEFING FOR GOVERNMENTS AND REGULATORS Accreditation is continuously gaining recognition as an important technical tool in the delivery of objectives across an increasing range of policy
More informationDiscontinuing the Metallic Handcuffs Compliance Testing Program and Request for
This document is scheduled to be published in the Federal Register on 09/14/2016 and available online at https://federalregister.gov/d/2016-22057, and on FDsys.gov Billing Code: 4410-18 DEPARTMENT OF JUSTICE
More informationCEN and CENELEC Position Paper on the draft regulation ''Cybersecurity Act''
CEN Identification number in the EC register: 63623305522-13 CENELEC Identification number in the EC register: 58258552517-56 CEN and CENELEC Position Paper on the draft regulation ''Cybersecurity Act''
More informationPRODUCT CERTIFICATION SCHEME FOR MECHANICAL-CUSTOMIZED VEHICLES
Ref No: RACS/SOP/57 Page 1 of 6 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) that Mechanical Customized
More informationTR TECHNICAL REQUIREMENTS FOR CERTIFICATION BODIES IN THE FIELD OF ROAD TRANSPORT MANAGEMENT SYSTEMS. Approved By:
TECHNICAL REQUIREMENTS FOR CERTIFICATION BODIES IN THE FIELD OF ROAD TRANSPORT MANAGEMENT SYSTEMS Approved By: Chief Executive Officer: Ron Josias Senior Manager: Mpho Phaloane Author: Project Manager:
More informationFood safety and trading in ASEAN
Regulations and Requirements for import and export of Food In ASEAN Panadda Silva Deputy Director, NIMT and Co-Chair of ASEAN Testing Laboratory Committee 18 January 2016 Food safety and trading in ASEAN
More informationACCREDITATION CRITERIA FOR MANAGEMENT SYSTEM CERTIFICATION BODIES ISSUE NO : 01 ISSUE DATE : 17/01/2015 PREFACE
International Standards Accreditation Council No.14, M.T.H Road, Opp to Vivekananda School, Vivekananda Nagar, Ambattur, Chennai 600 053. Tamil Nadu, India. Tel : 044 65554660 Email : info@isacglobal.org
More informationWith the successful completion of this course the participant will be able to:
ISO 13485:2016 INTRODUCTION COURSE COURSE DURATION: 1 DAY Course Summary: The introduction course provides the participant with an oversight on the requirements of ISO 13485:2016 standard. Our course is
More informationThe Value of ANSI Accreditation. Top 10 Advantages. of accredited third-party conformity assessment
The Value of ANSI Accreditation Top 10 Advantages of accredited third-party conformity assessment The American National Standards Institute (ANSI) offers highly recognized accreditation programs globally
More informationThe Benefits of Accreditation Using Developed Standards
The Benefits of Accreditation Using Developed Standards Chris Gunning Environmental Sciences Program Manager A2LA California State Water Resources Control Board August 10, 2015 Contents Who is A2LA? The17025:2005
More informationThe U.S. Government s Role in Standards and Conformity Assessment
The U.S. Government s Role in Standards and Conformity Assessment ASTM International-Russian Federation on Technical Regulating and Metrology Coordinated Program Mary Saunders Chief, Standards Services
More informationPRODUCT CERTIFICATION SCHEME FOR ORGANIC PRODUCTS
Ref No: RACS/SOP/36 Page 1 of 6 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) to assure that Organic
More informationANSI-CFP Accredited Food Protection Manager Certification Programs Education Outreach. Benefits of the ANSI-CFP Accredited Certification Programs
ANSI-CFP Accredited Food Protection Manager Certification Programs Education Outreach Benefits of the ANSI-CFP Accredited Certification Programs ANSI-CFP Accredited Food Protection Manager Certification
More information2 ACCREDITED AUDITORS
2 ACCREDITED AUDITORS 2.1 Auditor Accreditation 2.1.1 IBAC will issue auditor accreditation and appropriate credentials to individuals that apply for such accreditation and who meet the requirements established
More informationPARTNERING WITH THE REGULATORS: The Role for 3rd Party Accreditation in Food Safety
PARTNERING WITH THE REGULATORS: The Role for 3rd Party Accreditation in Food Safety Roger Brauninger American Association for Laboratory Accreditation (A2LA), Frederick, Maryland Topics Role of Accreditation
More informationInter American Accreditation Cooperation. IAAC, IAF and ILAC Resolutions Applicable to IAAC MLA Peer Evaluations
IAAC, IAF and ILAC Resolutions Applicable to IAAC MLA Peer Evaluations CLASSIFICATION This document is classified as an IAAC Mandatory Document. AUTHORIZATION Issue Nº: 07 Prepared by: MLA Committee and
More informationQMS in the ISO World: ISO 9001 and ISO Certification and Accreditation. Quality Confab. 3 November, Dan Tholen, M.S.
QMS in the ISO World: ISO 9001 and ISO 15189 - Certification and Accreditation Quality Confab 3 November, 2010 Dan Tholen, M.S. A2LA Presentation topics ISO 9001 vs 15189 In a nutshell Conformity Assessment
More informationPRODUCT CERTIFICATION SCHEME FOR FOOD-HONEY PRODUCTS
Ref No: RACS/PCS/14 Page 1 of 7 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) to assure that Honey
More informationBenefits of Accreditation and Conformity Assessment for Business
2008/SOM3/SCSC/CONF/032 Benefits of Accreditation and Conformity Assessment for Business Submitted by: APLAC 7 th Conference on Standards and Conformance Cusco, Peru 10-11 August 2008 Benefits of Accreditation
More informationLaboratory Capacity Building
Laboratory Capacity Building Presented by LIU Hanxia Chinese Academy of Inspection and Quarantine June 13, 2013 Outline I. The role of food testing in ensuring food safety II. Lab Accreditation in China
More informationISO/IEC INTERNATIONAL STANDARD. Conformity assessment Requirements for bodies certifying products, processes and services
INTERNATIONAL STANDARD ISO/IEC 17065 First edition 2012-09-15 Conformity assessment Requirements for bodies certifying products, processes and services Évaluation de la conformité Exigences pour les organismes
More informationCURRENT DEVELOPMENT AND NEW SERVICES IN MANAGEMENT SYSTEM CERTIFICATION
UPDATES & NETWORKING SESSION 2018 CURRENT DEVELOPMENT AND NEW SERVICES IN MANAGEMENT SYSTEM CERTIFICATION 1 NOVEMBER 2018 PRESENTED BY SIRIM QAS INTERNATIONAL SDN BHD MANAGEMENT SYSTEM CERTIFICATION DEPARTMENT
More informationRef No: RACS/PCS/10 Page 1 of 7. Revision No: 00 Revision Date: October 1, 2018 PRODUCT CERTIFICATION SCHEME FOR ELECTRICAL EQUIPMENT
Ref No: RACS/PCS/10 Page 1 of 7 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology (ESMA) to assure that Electrical
More informationAccreditation of Product Certification Scheme for Construction Materials By Ir C K Cheung Hong Kong Accreditation Service
Accreditation of Product Certification Scheme for Construction Materials By Ir C K Cheung Hong Kong Accreditation Service 1. Overview of HKAS Originated as an accreditation scheme called HOKLAS in 1985
More informationPRODUCT CERTIFICATION SCHEME FOR WATER PRODUCTS
Ref No: RACS/SOP/31 Page 1 of 6 1. Objective: This procedure describes the criteria implemented by RACS as Notified Body of Emirates Authority of Standardization and Metrology(ESMA) to assure that Water
More informationFederal Communication Commission (FCC) Office of Engineering and Technology (OET) Program Accreditation Procedure
PJLA offers third-party accreditation services to Conformity Assessment Bodies (i.e. Testing and/or Calibration Laboratories, Reference Material Producers, Field Sampling and Measurement Organizations
More informationLL-C (Certification) Services Overview
LL-C (Certification) Services Overview Who is LL-C (Certification)? LL-C (Certification) is an international certification body operating in more than 40 countries with experience in the field. Provides
More informationCertification Requirements Qualification-based Medical Device (ISO 13485:2016) Auditor Certification Program
Certification Requirements Qualification-based Medical Device (ISO 13485:2016) Auditor Certification Program Exemplar Global Personnel Certification Programs Exemplar Global is accredited by the Joint
More informationGRADUATE CERTIFICATE IN MANAGEMENT SYSTEMS ADMINISTRATION
GRADUATE CERTIFICATE IN MANAGEMENT SYSTEMS ADMINISTRATION If you are looking to develop expertise in a specialized area and broaden your knowledge base, but time and cost limitations are interfering with
More informationCertification Requirements Qualification-based Internal Auditor Certification Program
Certification Requirements Qualification-based Internal Auditor Certification Program Exemplar Global Personnel Certification Programs Exemplar Global is accredited by the Joint Accreditation System of
More informationPOSITION DESCRIPTION
UNCLASSIFIED IT Security Certification Assessor POSITION DESCRIPTION Unit, Directorate: Location: IT & Physical Security, Protective Security Wellington Salary range: H $77,711 - $116,567 Purpose of position:
More informationNational Accreditation Scheme
National Accreditation Scheme Rules of Procedure on the Preparation of Accreditation Audit Cycle NAR-25 Edition 3 Version 1 Approved by: Csaba Bodroghelyi Deputy Director General Responsible for preparation:
More informationSubsea Performance Bolt Workshop
Subsea Performance Bolt Workshop API Spec Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry, 9 th Edition API Spec
More informationStrengthening International Systems of Conformity Assessment
2011/SOM1/SCSC/CON1/014 Session 8 Strengthening International Systems of Conformity Assessment Submitted by: International Laboratory Accreditation Cooperation (ILAC) 6 th Conference on Good Regulatory
More informationISO/IEC TS Conformity assessment Guidelines for determining the duration of management system certification audits
TECHNICAL SPECIFICATION ISO/IEC TS 17023 First edition 2013-08-01 Conformity assessment Guidelines for determining the duration of management system certification audits Évaluation de la conformité Lignes
More informationS. Scholz / K. Meyer / J.E. Nielsen / Harald Drück/J.Fernández/E.Prado/L.Nelson Page 1 of 7
Global Solar Certification Network Working Rules Annex A. Requirements for Certification Bodies and their subcontracted laboratories, inspection bodies and inspectors Date: 2017/03/07 Document number:
More informationChina s Certification System for ICT Equipment. Mr. Dabing Ling TL Certification Institute, CAICT
China s Certification System for ICT Equipment Mr. Dabing Ling TL Certification Institute, CAICT 2017-10-30 1 Course Objectives 1 Introduce China s certification system for ICT equipment 2 Provide reference
More informationGovernmental acceptance supported by accredited certification. Presentation to the GLOBALG.A.P SUMMIT 2012
Governmental acceptance supported by accredited certification Presentation to the GLOBALG.A.P SUMMIT 2012 Thomas Facklam INTERNATIONAL ACCREDITATION FORUM, INC. Certified once-accepted everywhere 1 Content
More informationMinimum Scheme Requirements to Certify Criminal Justice Restraints Described
This document is scheduled to be published in the Federal Register on 07/13/2017 and available online at https://federalregister.gov/d/2017-14638, and on FDsys.gov Billing Code: 4410-18 DEPARTMENT OF JUSTICE
More informationUSDA ISO Guide 65 Program Accreditation for Certification Bodies
Page 1 of 6 USDA ISO Guide 65 Program Accreditation for Certification Bodies 1 Purpose This document provides the requirements to be met in designing a USDA ISO Guide 65 Program. It also provides the requirements
More informationFood Safety Modernization Act
Food Safety Modernization Act Allan González, M.Sc. Analista Regulatorio Internacional Oficina Regional para Latinoamérica Administración de Alimentos y Medicamentos (FDA) Embajada EEUU, San José, Costa
More information