Global Harmonization Task Force SG3 Comments and Recommendations ISO/DIS 9001: 2000 and ISO/DIS 9000: 2000 And Revision of ISO and 13488
|
|
- Jeffrey Merritt
- 5 years ago
- Views:
Transcription
1 Page 1 of 6 Global Harmonization Task Force SG3 ISO/DIS 9001: 2000 and ISO/DIS 9000: 2000 And Revision of ISO and GENERAL COMMENTS The Global Harmonization Task Force Study Group Three (GHTF SG3) is providing these comments and suggestions to ISO TC 176 and ISO TC210 WG1 for consideration. As described in the Memorandum of Understanding between the GHTF and ISO TC210, the members of SG3 look forward to working closely with WG1 to develop a revised set of standards which meet the needs of the regulated medical device community. GHTF SG3 will also be making these comments and suggestions available to other organizations, such as national standards bodies, medical device regulatory agencies and the medical device community in an effort to communicate concerns regarding the ISO revision and the need to revise ISO and ISO 9001: 2000 has been drafted by ISO TC 176 to accommodate a wide community of users. These users have desired an update of the previous version of ISO 9001 which was largely based on a need for a contract between a supplier and a customer and the need of the customer to be assured of the quality of the purchased product. The revisions in ISO 9001: 2000 are intended to extend this concept to facilitate a third party assessment and certification of quality systems to a wide range of organizations, including manufacturers, service organizations and others. ISO TC 176 has stated The ISO 9001: 2000 quality management systems requirements has been specifically developed to be applicable to any type of generic product (hardware, software, services and processed materials), to be applied by any size of organization and can be implemented by any sector of industry or commerce without the need for guidance. Also, the intent is to be compatible with the environmental management system standard (ISO 14001). Whereas the objective of TC 176 may be met by these revisions, many of the revisions make the use of ISO 9001: 2000 inappropriate for the regulated medical device industry. As a tool for an industry in which the quality system is regulated, a standard must be precise in its requirements, capable of being objectively audited and limited to those quality system requirements which assure safety and performance of products. The major concerns with the ISO 9001: 2000 DIS continue to be: The process model diagram (figure 1) adds no value to the description of the process approach: the text in the second paragraph of 0.2 Process approach is clear. Currently, the figure adds confusion leading some assessment organizations to add additional requirements beyond those in the standard. We suggest that the figure and the related text in 0.2 be eliminated.
2 Page 2 of 6 Permissible exclusions allow the reduction of certain requirements by particular organizations. The regulated medical device industry must have clearly identified requirements that cannot be reduced by individual organizations. The permissible exclusion provision is open to too many interpretations and does not consistently accomplish the tiering of the current ISO 9001, 9002 and 9003 structure. Whereas customer satisfaction is key for commercial success, it is not a quality system requirement in the medical device industry. The medical device quality system requirements are aimed primarily at providing safe medical devices that perform as intended. Customer satisfaction belongs to the psychological domain, which is very subjective. Current quality assurance standards are in the logical domain that can be objectively evaluated. Customer satisfaction may at times be in direct conflict with safety and performance concerns. Reuse of single use devices is an example of this situation. The concepts of continual improvement and quality improvement: (ISO/DIS 9000: Quality improvement - part of quality management focused on increasing effectiveness and efficiency. Note: The term continual quality improvement is used when quality improvement is progressive and the organization actively seeks and pursues improvement opportunities. ) are pervasive throughout ISO/DIS 9001:2000 i.e., 5.4.1, 5.4.2, 8.5.1, and go beyond the baseline quality assurance requirements of 9001:1994. Regulators in the medical device industry, for public health purposes, must be concerned with product quality and improvement through corrective and preventive actions to ensure product safety and performance. Regulators are not and should not be regulating business performance, quality efficiency, or improvements of the management system outside of corrective and preventive actions. Several requirements in ISO 9001: 1994 contain more detail, (for example internal audit, control of nonconforming product, and the corrective action); much of this detail should be retained. ISO/DIS 9001: 2000 has been generalized, and this specificity has been deleted. As such, the standard is less prescriptive and instructive which will result in inconsistency in the application and assessment of the standard. Various sections of ISO/DIS 9001: 2000 DIS are poorly worded and constructed. Some structures are in conflict with ISO Directives in that requirements are included in notes and definitions. Some examples of these are noted in the detailed comments below. RECOMMENDATIONS TO ISO/TC 210 WG1 ISO/DIS 9001: 2000 is a complete revision of the 1994 version of ISO This will outdate the current ISO and GHTF SG3 recommends that:
3 Page 3 of 6 ISO/DIS 9001: 2000 combines ISO 9001, 9002, 9003: 1994 into a single standard. ISO TC210 WG1 should revise both ISO and to maintain the tiering of requirements that fit many existing medical device regulatory schemes. The level and nature of the requirements should remain essentially the same. ISO and should be revised to be as similar as possible to the format and terminology of ISO 9001: This will allow organizations to meet the requirements of both ISO 9001: 2000 and ISO or with one quality system. Specific comments as detailed below should be considered in the revised ISO and SPECIFIC COMMENTS Requirement The term requirement as used throughout ISO/DIS 9001: 2000 is not always qualified, and can be misleading in intent. The term requirement is a broad based concept which should be qualified in the revised ISO and This qualification may be quality system requirement, customer requirement, standard requirement, etc. Documentation Throughout ISO DIS there are references to documentation and requirements for documentation and records. These requirements are often not clear. A distinction for documented procedures is identified in section 4.2 a) that is not continued through the rest of ISO DIS. For example, the last sentence of section 5.3 of ISO DIS uses the term controlled which may or may not be interpreted as documented. ISO , and are more precise regarding requirements for documentation and records. The revised ISO and should maintain the precision and consistency in requirements for documentation and records. Process Model The process model in 0.2 of ISO DIS should not be included in the revised ISO and This model is theory and inappropriate for a requirements standard. It would be misleading to organizations and assessment bodies, which may interpret it as a justification to add additional requirements on a case-by-case basis to tailor the standard to a specific organization. Additional requirements for the medical device sector should be debated and applied in an open public forum to assure a level playing field of requirements and enforcement.
4 Page 4 of 6 Customer Satisfaction Customer satisfaction is included in 1.1(b), 5.2 and various other sections of ISO DIS. Although customer satisfaction is essential for a successful commercial enterprise, it is inappropriate as a regulatory requirement. Aspects of customer satisfaction should not be included in the revised ISO and Section of ISO DIS specifically requires monitoring of customer satisfaction. This should be replaced with the concepts from the existing ISO and 13488, which supplements ISO in section These concepts require a documented feedback system to provide early warning of quality problems. Permissible Exclusions Section 1.2 of ISO DIS allows for exclusion of quality system requirements. This is inappropriate for regulatory purposes. The revised ISO and should not include the provision for permissible exclusions, but should rather include the tiering of and as described above. Continual Improvement Section 4.1 of ISO DIS requires continual improvement of the organization. This requirement is carried forward in many other sections of the DIS. Continual improvement may be a key element of success for some commercial enterprises, but it is inappropriate as a regulatory requirement. The revised ISO and should continue to include requirements for compliance with customer, safety, performance and regulatory requirements. However any reference to continual improvement should be not be included in the revised ISO and Quality Policy Section 5.3 d) of ISO DIS requires that only appropriate levels of the organization should receive and understand the quality policy. ISO requires all levels to understand the quality policy. ISO and should be revised to include all levels. Quality Planning Section 5.4 of ISO DIS includes enhanced requirements for quality planning. The enhancements clarify what was previously a confusing requirement. The revised ISO and should include these enhancements. Reporting Relationships Section of ISO DIS does not include the requirement that the management representative and the quality function have the organizational freedom as described in of ISO
5 Page 5 of The revised ISO and should include the requirement for the same level of organizational freedom as ISO Work Environment Section 6.4 of ISO DIS includes requirements for the work environment. This section should be deleted from the revised ISO and Requirements such as employee cleanliness and health should be included in sections 6.2 and 6.3 of the revised ISO and as appropriate. Realization Section 7.0 of ISO DIS is titled Product and/or service realization. The term realization is confusing in this context and may not be appropriately translated. The revised ISO and should use a more appropriate term. Design and/or Development Section 7.3 in ISO DIS is captioned Design and/or development. This is confusing and misleading. The issue is particularly significant because medical device regulations make a distinction between activities that precede formally establishing design input requirements and subsequent activities. The section should be reverted back to Design control and design control concepts carried through the rest of section 7.3. The definition for design and development in ISO DIS should not be adopted, but rather a more appropriate definition for design control should be added to the revised ISO and The flow of activities in Section 7.3 of ISO DIS is poorly worded and confusing. The imprecise use of the term requirement and the use of various elements for design inputs and review should be clarified in the revised ISO and Distinctions between design control for new or custom products should be clarified from contract review and routine orders for existing products. In section of ISO DIS a requirement for development validation is inappropriate and should be deleted in the revised ISO and Process Validation Section of ISO DIS includes new requirements for process validation. The complex issue of output that cannot be verified is clarified in the DIS. The revised ISO and should include these new and clarified requirements. Software Validation The wording in ISO DIS in section 7.6 regarding software validation is unclear and should be reworded in the revised ISO and
6 Page 6 of 6 Control of Nonconformity Section 8.3 of ISO DIS allows only one disposition of nonconforming product: correction and re-verification. The three other possible dispositions from ISO , Section should also be available in the revised ISO and Improvement Section 8.5 of ISO DIS is titled Improvement. The revised ISO and section 8.5 should be titled Corrective and Preventive Action. Paragraph of ISO DIS should be deleted in the revised ISO and
a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210
a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210 for SMEs a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210 Copyright protected document All rights reserved.
More informationa practical guide Medical Devices Advice from ISO/TC 210 This is a free 11 page sample. Access the full version online.
NSAI/ISO Guide to ISO 13485:2016 Medical Devices a practical guide Advice from ISO/TC 210 NSAI/ISO Guide to ISO 13485:2016 This Guide is the NSAI adoption of and is technically identical to the English
More informationIAASB Main Agenda (March 2005) Page Agenda Item. DRAFT EXPLANATORY MEMORANDUM ISA 701 and ISA 702 Exposure Drafts February 2005
IAASB Main Agenda (March 2005) Page 2005 579 Agenda Item 13-F DRAFT EXPLANATORY MEMORANDUM ISA 701 and ISA 702 Exposure Drafts February 2005 Introduction This memorandum provides some background to, and
More informationGeneral Chapter/Section: <232> Elemental Impurities - Limits Expert Committee(s): General Chapters Chemical Analysis No.
General Chapter/Section: Elemental Impurities - Limits Expert Committee(s): General Chapters Chemical Analysis No. of Commenters: 18 Editorial changes suggested by commenters have been reviewed by
More informationn version of 22 may 2017 Implementing ISO and transition from OHSAS 18001
Implementing ISO 45001 and transition from OHSAS 18001 Implementing ISO 45001 and transition from OHSAS 18001 1 We at SCCM are convinced and our experience has proven that any organization, large or small,
More informationWelcome to presentation By Sanjay Punjabi Lead Auditor for ISO 9001, ISO 14001, OHSAS & BS 7799
Welcome to presentation By Sanjay Punjabi Lead Auditor for ISO 9001, ISO 14001, OHSAS 18001 & BS 7799 NETPECKERS CONSULTING (P) LTD. An ISO 9001:2000 compliant organization On Advantages, importance &
More informationUALITY SYSTEMS STANDARDS
UALITY SYSTEMS STANDARDS VICTOR DORMAN-SMITH ABBOTT IRELAND Singapore 2002/05/17 BASIC STANDARDS ISO 9001, 2 & 3:1994 ISO 9001:2000 EN 46001, 2 :1993 Revised in 1996 ISO 13485 & 8:1996 DIS 13485:2002 =(ISO
More informationCommitted to Environment, Health and Safety
Committed to Environment, Health and Safety Environment, Health and Safety Management System and Policy of GCP Applied Technologies Inc. SEPTEMBER 1, 2017 The GCP Environment, Health, and Safety Management
More informationANSI/ASNT CP-189 Inquiries
ANSI/ASNT CP-189 Inquiries ANSI/ASNT CP-189: Standard for Qualification and Certification of Nondestructive Testing Personnel was developed and coordinated using American National Standards Institute (ANSI)
More informationISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations
Agenda Item 1-A ISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations Introduction 1. Since the September 2016
More informationQuality Management System Certification. Understanding Quality Management System (QMS) certification
Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality
More informationFiona Campbell. ISA 315 (Revised) Responding to Comments to the Exposure Draft. Deputy Chair of the IAASB and Chair of the ISA 315 Task Force
ISA 315 (Revised) Responding to Comments to the Exposure Draft IAASB Meeting March 12 th, 2019 Fiona Campbell Deputy Chair of the IAASB and Chair of the ISA 315 Task Force Responses to ED-315 Broad concerns
More informationFDA issues long-awaited final guidance on when a device modification requires a new 510(k)
FDA issues long-awaited final guidance on when a device modification requires a new 510(k) November 2, 2017 Six years after its first attempt to update its 20-year-old guidelines for when modifications
More informationNANDTB-F012 Rev 0 Audit Checklist
NANDTB-F012 Rev 0 Audit Checklist 1. Foreword Minimum Requirements for the Structured Training of Non-Destructive Testing Institutes This document is based upon CEN Technical Report 25108:2006, which is
More informationQuality Assurance Policy. for the. Procurement of HIV Point-of-Care Technology. under the UNITAID Grant
Quality Assurance Policy for the Procurement of HIV Point-of-Care Technology under the UNITAID Grant UNICEF Supply Division Quality Assurance Centre and Health Technology Centre Revisions Version Date
More informationCommitted to Environment, Health, & Safety
Committed to Environment, Health, & Safety Environment, Health, and Safety Management System and Policy of W. R. Grace & Co. November 8, 2018 The Grace Environment, Health, and Safety Management System,
More informationBasis for Conclusions: ISA 230 (Redrafted), Audit Documentation
Basis for Conclusions: ISA 230 (Redrafted), Audit Documentation Prepared by the Staff of the International Auditing and Assurance Standards Board December 2007 , AUDIT DOCUMENTATION This Basis for Conclusions
More informationQuality Assurance Standard. Implemented 1991 Revised Version 3.0
Implemented 1991 Revised 2006 Version 3.0 IQPP Contents I. Introduction... 3 II. Definitions... 4 III. PPTA Source Quality Assurance Principles... 4 IV. Audits and Compliance Verification... 5 Page 2 IQPP
More informationCOMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES
COMPETENT AUTHORITY (UK) 10 EC MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES (CUSTOM MADE DEVICES) Updated March 2008 CONTENTS PAGE Introduction 3 Definition of dental
More informationINTERNATIONAL STANDARD ON ASSURANCE ENGAGEMENTS 3000 ASSURANCE ENGAGEMENTS OTHER THAN AUDITS OR REVIEWS OF HISTORICAL FINANCIAL INFORMATION CONTENTS
INTERNATIONAL STANDARD ON ASSURANCE ENGAGEMENTS 3000 ASSURANCE ENGAGEMENTS OTHER THAN AUDITS OR REVIEWS OF HISTORICAL FINANCIAL INFORMATION (Effective for assurance reports dated on or after January 1,
More informationliterature that drug combinations containing butalbital should not be used in treatment of chronic pain and are not appropriate for long term routine
ACTION: Original BIA p(111397) pa(192459) d: (446870) DATE: 09/16/2013 2:14 PM print date: 04/02/2019 9:58 PM 1. Limit reimbursement for sedative hypnotic agents to the following medications: zolpidem
More informationOHSAS Project Group. Implementation Guidance for migrating from OHSAS 18001:2007 to ISO 45001:2018 CONTENTS 1.0 INTRODUCTION
OHSAS Project Group Implementation Guidance for migrating from OHSAS 18001:2007 to ISO 45001:2018 CONTENTS 1.0 INTRODUCTION 2.0 BACKGROUND ON ISO 45001 DEVELOPMENT PROCESS 3.0 USER GROUPS 4.0 IMPLEMENTATION
More information15 May 2017 Exposure Draft. Response Due Date 23 June Exposure Draft
15 May 2017 Exposure Draft Response Due Date 23 June 2017 Exposure Draft Proposed Application Material Relating to: (a) Professional Skepticism Linkage with the Fundamental Principles; and (b) Professional
More informationISO and the Delivery of Competent NDT Services
ISO 17025 and the Delivery of Competent NDT Services Brett Hyland Delivery of Competent NDT Services OH&S legislation places responsibility on those appointing subcontractors/suppliers to ensure their
More informationResponsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA.
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51) Document issued on: May 27, 2001 U.S. Department of Health
More informationJICPA comments on the IESBA Exposure Draft, Proposed Revisions to the Code Pertaining to the Offering and Accepting of Inducements
The Japanese Institute of Certified Public Accountants 4-4-1 Kudan-Minami, Chiyoda-ku, Tokyo 102-8264, Japan Phone: 81-3-3515-1130 Fax: 81-3-5226-3355 Email: international@sec.jicpa.or.jp December 8, 2017
More informationComparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome
Comparability and quality of experimental data under different quality systems S. Caroli Istituto Superiore di Sanità Rome Programme of this presentation Part I. Background information Part II. Key aspects
More informationExposure Draft, ISA 720 (Revised) The Auditor s Responsibilities Relating to Other Information
Tel +44 (0)20 7694 8871 8 Salisbury Square Fax +44 (0)20 7694 8429 London EC4Y 8BB sylvia.smith@kpmgifrg.com United Kingdom Technical Director International Auditing and Assurance Standards Board International
More informationAugust 3, RE: Specially Designed Definition (Federal Register Notice of June 19, 2012; RIN 0694-AF66)
August 3, 2012 Mr. Timothy Mooney Regulatory Policy Division Bureau of Industry and Security U.S. Department of Commerce 14 th Street Pennsylvania Ave., N.W. Washington, D.C. 20230 RE: Specially Designed
More informationDate Supersedes document
COMMITTEE DRAFT ISO/CD 18841-1 Date 2014-11-21 Supersedes document Reference number ISO/TC 37 / SC 5 N 0125 WARNING: This document is not an International Standard. It is distributed for review and comment.
More informationITIL v3 Service Management as a Practice
ITIL v3 as a Practice 1 as a Practice ITIL = IT Infrastructure Library Set of books giving guidance on the provision of quality IT services Common language Best practices in delivery of IT services Not
More informationRE: IESBA s Exposure Draft Proposed Revisions Pertaining to Safeguards in the Code Phase 1
31 March 2016 Mr. Ken Siong Technical Director International Ethics Standards Board for Accountants (IESBA) International Federation of Accountants (IFAC) 529 Fifth Avenue, 6 th Floor New York, New York
More informationSterilization of health care products Radiation. Part 3: Guidance on dosimetric aspects of development, validation and routine control
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 11137-3 Second edition 2017-06 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation
More informationAchieving Effective and Reliable NDT in the Context of RBI
Achieving Effective and Reliable NDT in the Context of RBI S Smalley, Royal & SunAlliance & B W Kenzie, TWI 1. SCOPE Plant owners/operators are now managing the integrity of their plant and planning inspection
More informationAlignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference
Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference Donald Kautter US Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food
More informationISO 13485:2016 MEDICAL DEVICES QMS TRANSITION GUIDE
ISO 13485:2016 MEDICAL DEVICES QMS TRANSITION GUIDE ISO 13485, OVERVIEW ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services.
More informationIAF Mandatory Document. Requirements for the Migration to ISO 45001:2018 from OHSAS 18001:2007 (IAF MD 21:2018)
IAF Mandatory Document Requirements for the Migration to ISO 45001:2018 from OHSAS 18001:2007 Issue 1 (IAF MD 21:2018) Issue 1 Requirements for the Migration to Page 2 of 12 The (IAF) facilitates trade
More informationMedidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer
Nano-Tera.ch 05 February 2015 part 4 Intro ISO GMP - GLP Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 Introduction to ISO 13485, cgmp s and GLP s Context
More informationFood Safety Modernization Act - Impacts on the Grain and Feed Industry
Food Safety Modernization Act - Impacts on the Grain and Feed Industry NGFA 117th Annual Meeting and Convention March 17, 2013 San Francisco, California David Fairfield, NGFA Vice President of Feed Services
More informationAuditing Standards and Practices Council
Auditing Standards and Practices Council Philippine Standard on Assurance Engagements 3000 (Revised) ASSURANCE ENGAGEMENTS OTHER THAN AUDITS OR REVIEWS OF HISTORICAL FINANCIAL INFORMATION PHILIPPINE STANDARD
More information2017 FDA Food Code. FDA/CFSAN Retail Food Policy Team
2017 FDA Food Code FDA/CFSAN Retail Food Policy Team The FDA Food Code: Provides FDA s current thinking on food safety and sanitation in the retail food sector. Can be uniformly adopted as a statute, regulation
More informationCOUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893
COUNCIL OF THE EUROPEAN UNION Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DLEG 51 CODEC 893 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Common Position with
More informationIAASB Exposure Draft, Proposed ISAE 3000 (Revised), Assurance Engagements Other Than Audits or Reviews of Historical Financial Information
Tel +44 (0) 20 7694 8871 Fax +44 (0) 20 7694 8429 8 Salisbury Square DX 38050 Blackfriars London EC4Y 8BB sylvia.smith@kpmgifrg.com United Kingdom Technical Director International Auditing and Assurance
More informationQuality Assurance Documents
Non-Destructive Testing Society ( Singapore) Quality Assurance Documents SCHEME MANUAL EN 4179:2017 - Qualification & Certification of NDT Personnel engaged in Aerospace Industries Prepared By: Reviewed
More informationRe: Docket No. FDA D Presenting Risk Information in Prescription Drug and Medical Device Promotion
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org August 25, 2009 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville,
More informationJoint ICTP-IAEA School of Nuclear Energy Management August The IAEA Safety Standards. Dominique Delattre IAEA, Vienna Austria
2257-51 Joint ICTP-IAEA School of Nuclear Energy Management 8-26 August 2011 The IAEA Safety Standards Dominique Delattre IAEA, Vienna Austria HISTORY, PROCESS AND CURRENT STATUS OF THE IAEA SAFETY STANDARDS
More informationResearch on the Administrative Rules of APIs, Pharmaceutical Excipients and Auxiliary Materials Master File. Translation version
Research on the Administrative Rules of APIs, Pharmaceutical Excipients and Auxiliary Materials Master File Division of Pharmaceuticals Department of Drug Registration Hou Renping Translation version Main
More informationFFI Report Review: Final Rule for FSMA Preventative Controls Regarding Food Fraud and EMA
FFI Report Review: Final Rule for FSMA Preventative Controls Regarding Food Fraud and EMA By Spink & Moyer SUMMARY (150 word brief): This is the MSU Food Fraud Initiative review of the Food Safety Modernization
More informationMEMORANDUM. NFPA Technical Committee on Explosion Protection Systems. NFPA 69 First Draft TC FINAL Ballot Results (F2013 Cycle)
National Fire Protection Association 1 Batterymarch Park, Quincy, MA 02169-7471 Phone: 617-770-3000 Fax: 617-770-0700 www.nfpa.org MEMORANDUM To: From: NFPA Technical Committee on Explosion Protection
More informationNuclear energy, nuclear technologies, and radiological protection Vocabulary. Part 4: Dosimetry for radiation processing
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 12749-4 First edition 2015-08-15 Nuclear energy, nuclear technologies, and radiological protection Vocabulary Part 4: Dosimetry for radiation processing
More informationGuidance for Industry
MEDICAL DEVICES SECTOR Guidance for Industry Format and Content of Proposed Bundling/Grouping Criteria for Medical Devices DRAFT GUIDANCE This guidance document is being distributed for comment purposes
More informationISO INTERNATIONAL STANDARD. Non-destructive testing Qualification of personnel for limited applications of non-destructive testing
INTERNATIONAL STANDARD ISO 20807 First edition 2004-03-01 Non-destructive testing Qualification of personnel for limited applications of non-destructive testing Essais non destructifs Qualification du
More informationEUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. PHARMACEUTICAL COMMITTEE 21 October 2015
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, European Medicines Agency PHARM 689 PHARMACEUTICAL COMMITTEE 21 October 2015
More informationTRANSLATION. Montreal, April 11, 2011
TRANSLATION Montreal, April 11, 2011 Technical Director International Auditing and Assurance Standards Board 545 Fifth Avenue, 14 th Floor New York, New York 10017 USA Dear Madam/Sir: Please find enclosed
More informationGROCERY MANUFACTURERS ASSOCIATION. Science Forum. Connecting Sound Science and Responsible Solutions
GROCERY MANUFACTURERS ASSOCIATION Science Forum Connecting Sound Science and Responsible Solutions FSMA Implementation Michael M. Landa Director, Center for Food Safety and Applied Nutrition Food and Drug
More informationMDEP VICWG-02. Technical Report
MDEP Related to: Vendor Inspection Cooperation Working Group Activities Survey on quality assurance program requirements 1 1) Background: The survey was prepared using the requirements of Appendix B to
More informationTOBACCO PRODUCT OR MEDICAL PRODUCT?
TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:
More informationFinal Rule for Preventive Controls for Animal Food
Final Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Background Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
More informationFORUM FOR AEROSPACE NDT BOARDS
FORUM FOR AEROSPACE NDT BOARDS An overview of the activities of the Forum for National Aerospace NDT Boards ANDTBF/04; Rev: 2010-06-08 What is a NANDTB? EASA regulations part 145 (covering NDT in maintenance)
More informationATTACHMENT A AdvaMed Comments Draft-Guidance for Industry and FDA Staff -510(k) Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device Line(s) No. Line or lines numbers of the
More informationAssurance Engagements Other than Audits or Review of Historical Financial Statements
Issued December 2007 International Standard on Assurance Engagements Assurance Engagements Other than Audits or Review of Historical Financial Statements The Malaysian Institute Of Certified Public Accountants
More informationEnvironmental, Health and Safety
Environmental, Health and Safety Codes of Practice The Environmental, Health and Safety (EHS) Codes of Practice set forth Zimmer EHS requirements for our business functions and facilities worldwide. In
More informationLEAF Marque Assurance Programme
Invisible ISEAL Code It is important that the integrity of the LEAF Marque Standard is upheld therefore the LEAF Marque Standards System has an Assurance Programme to ensure this. This document outlines
More informationImpact Summary: Therapeutic Products Bill Personal Import of Medicine by mail/courier
Impact Summary: Therapeutic Products Bill Personal Import of Medicine by mail/courier Section 1: General information Purpose The Ministry of Health is solely responsible for the analysis and advice set
More informationInternational Framework for Assurance Engagements
FRAMEWORK March 2015 Framework International Framework for Assurance Engagements Explanatory Foreword The Council of the Malaysian Institute of Accountants has approved this International Framework for
More informationIMPLEMENTATION COURSE (MODULE 1) (ISO 45001:2016 AVAILABLE ON REQUEST) COURSE DURATION: 3 DAYS FOR OHSAS 18001:2007 OR ISO 45001:2016
OHSAS 18001:2007 IMPLEMENTATION COURSE (MODULE 1) (ISO 45001:2016 AVAILABLE ON REQUEST) COURSE DURATION: 3 DAYS FOR OHSAS 18001:2007 OR ISO 45001:2016 Course Summary: The implementation course provides
More informationSoftware as a Medical Device (SaMD)
Software as a Medical Device (SaMD) Clinical Evaluation IMDRF/SaMD WG (WD2)/N41R1: 2016 Bakul Patel, USA FDA Chair SaMD Working Group Scope NWIE Proposal - Software as a Medical Device (SaMD): Clinical
More informationTGA: the current regulatory reform agenda
TGA: the current regulatory reform agenda ASMI 2012 Conference: 13 November 2012 Future proofing the consumer healthcare industry Dr John Skerritt, National Manager The Therapeutic Goods Administration
More informationJOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON CONTAMINANTS IN FOODS 12 th Session Utrecht, The Netherlands, March 2018 PROPOSED
E Agenda Item 9 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON CONTAMINANTS IN FOODS 12 th Session Utrecht, The Netherlands, 12-16 March 2018 CX/CF 18/12/9-Add.1 PROPOSED DRAFT CODE OF PRACTICE
More informationReferences to people who are obese in weight loss advertising
References to people who are obese in weight loss advertising CAP and BCAP s regulatory statement on their decision to allow certain providers to make references to obesity Contents 1. Executive Summary...
More informationMedical - Combined Medical Devices Guideline
Medical - Combined Medical Devices Guideline V 2.0- EFFECTIVE: 1ST OF AUG 2016 Medical - Combined Medical Devices Guideline 1 2 Medical - Combined Medical Devices Guideline Title TABLE OF CONTENTS Definitions
More informationCARIBX (UK) LIMITED. Environmental, Health and Safety Management System. Revision: 00 APRIL 2011
CARIBX (UK) LIMITED Environmental, Health and Safety Management System Revision: 00 APRIL 2011 Document Details and Issue Record Rev No. Details Date Author Checked Text 00 Draft 01/04/2011 CJMD Calcs
More informationCMA response to TGO 92- Standards for the labels of non-prescription medicines
CMA response to TGO 92- Standards for the labels of non-prescription medicines Proposed Requirement TGO 92 Text size Text size equivalent to Arial font has been removed from TGO 92. The definition for
More informationComment response document for NPA
Comment response document for NPA 145-11 A total of 20 commnets were received from 4 JAA-NAAs, 1 JAA Central Division, 2 Euro Associations, 8 JAR145 organisations, 1 USA Manufacturer and 1 European Operator.
More informationOverhauling The 510(k) Process
Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Overhauling The 510(k) Process Law360, New York (August
More informationNA LEVEL 3 TECHNICAL QUALIFICATION RECOGNITION
NA-019 - LEVEL 3 TECHNICAL QUALIFICATION RECOGNITION Introduction This procedure reflects the adoption of the EN4179-2014 wording as Australian Standard AS3669, and describes the NANDTB processes when
More informationEHR Developer Code of Conduct Frequently Asked Questions
EHR Developer Code of Conduct Frequently Asked Questions General What is the purpose of the EHR Developer Code of Conduct? EHR Association (the Association) members have a long tradition of working with
More informationCertification of NDT Personnel: Current Perspective & Future Outlook
Certification of NDT Personnel: Current Perspective & Future Outlook P.K. Yuen Manager - NRCan/CGSB NDT Personnel Certifying Agency CANMET Materials Technology Laboratory Natural Resources Canada - Government
More informationLegislative Report: 5010/ICD-10 --------------------------------- WEDI EHR Work Group: Electronic Health Record Product and Vendor Profile Site (Draft) Robert M. Tennant MGMA Co-chair, WEDI EHR WG HR 4157
More informationWORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI. Ethical Principles for Biomedical Research Involving Human Beings
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Biomedical Research Involving Human Beings WMA Review of the Declaration of Helsinki Consultation Response of the PHG Foundation
More information11 September Tower Old Broad Street London EC2N 1HQ United Kingdom t + 44 (0) f + 44 (0)
11 September 2007 Jim Sylph International Auditing and Assurance Standards Board 545 5th Avenue, 14th Floor New York, New York 10017 USA Edcomments@ifac.org Tower 42 25 Old Broad Street London EC2N 1HQ
More informationWTO Agreement on Trade Facilitation The WCO s Role and the Customs Community in Implementing the TFA
WTO Agreement on Trade Facilitation The WCO s Role and the Customs Community in Implementing the TFA 16 June 2014 Dublin Resolution WCO Instruments and Tools 1 What is the WCO? The WCO represents 179 Customs
More informationDarwin Marine Supply Base HSEQ Quality Management Plan
Darwin Marine Supply Base HSEQ Quality Management Plan REVISION SUMMARY Revision Date Comment Authorised 0 29.9.13 Initial input JC 1 12.1.15 General Review JC 2 3 4 5 6 7 8 9 Revision Log Revision No
More informationAlberta Alcohol and Drug Abuse Commission. POSITION ON EMPLOYMENT-RELATED ALCOHOL AND DRUG TESTING November 2006
Alberta Alcohol and Drug Abuse Commission POSITION ON EMPLOYMENT-RELATED ALCOHOL AND DRUG TESTING POSITION The Alberta Alcohol and Drug Abuse Commission (AADAC) does not recommend alcohol and drug testing
More informationTACKLING WITH REVIEWER S COMMENTS:
TACKLING WITH REVIEWER S COMMENTS: Comment (a): The abstract of the research paper does not provide a bird s eye view (snapshot view) of what is being discussed throughout the paper. The reader is likely
More informationAKA Good Manufacturing Practice (GMP) Certification Program
AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements
More informationC 178/2 Official Journal of the European Union
C 178/2 Official Journal of the European Union 29.7.2003 Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (2003/C
More informationEuropean Federation of Statisticians in the Pharmaceutical Industry (EFSPI)
Page 1 of 14 European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) COMMENTS ON DRAFT FDA Guidance for Industry - Non-Inferiority Clinical Trials Rapporteur: Bernhard Huitfeldt (bernhard.huitfeldt@astrazeneca.com)
More informationThe Role of the WCO Implementing the WTO Agreement on Trade Facilitation
The Role of the WCO Implementing the WTO Agreement on Trade Facilitation Ulaanbaatar, Mongolia 2-3 June 2014 Changsheng Li Compliance and Facilitation Directorate World Customs Organization Changsheng.li@wcoomd.org
More informationVintage and Nonconforming Amendments to Salt Lake City s Sign Ordinance
BRIEFING MEMO PLANNING DIVISION DEPARTMENT of COMMUNITY and NEIGHBORHOODS ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
More informationPsychotherapists and Counsellors Professional Liaison Group (PLG) 30 September 2010
Psychotherapists and Counsellors Professional Liaison Group (PLG) 30 September 2010 Information for organisations invited to present to meetings of the Psychotherapists and Counsellors Professional Liaison
More informationBusiness Impact Analysis
ACTION: Original DATE: 05/01/2018 10:55 AM Business Impact Analysis Agency Name: Ohio Department of Health Regulation/Package Title: Chapter 3701-52 Smoke Free Workplace Rule Number(s): 3701-52 Date: November
More informationCurrent through Chapter 199 and Chapters of the 2015 Legislative Session
26-21-101. Short title. 26-21-101. Short title This article shall be known and may be cited as the "Colorado Commission for the Deaf and Hard of Hearing Act". Cite as C.R.S. 26-21-101 History. L. 2000:
More informationIS0 INTERNATIONAL STANDARD. Ostomy collection bags - Part 2: Poches de recueil pour stomie - Parfie 2: Prescriptions et m&hodes d essai
INTERNATIONAL STANDARD IS0 8670-2 Second edition 1996-12-15 Ostomy collection bags - Part 2: Requirements Poches de recueil pour stomie - and test methods Parfie 2: Prescriptions et m&hodes d essai Reference
More informationCalifornia Environmental Protection Agency
California Environmental Protection Agency OCTOBER 2004 ENVIRONMENTAL JUSTICE ACTION PLAN TABLE OF CONTENTS 1. INTRODUCTION...2 1.1 Purpose... 2 1.2 Development and Update...3 2. OBJECTIVES...4 2.1 Develop
More informationHealth informatics Digital imaging and communication in medicine (DICOM) including workflow and data management
INTERNATIONAL STANDARD ISO 12052 Second edition 2017-08 Health informatics Digital imaging and communication in medicine (DICOM) including workflow and data management Informatique de santé Imagerie numérique
More informationUse of Standards in Substantial Equivalence Determinations
Guidance for Industry and for FDA Staff Use of Standards in Substantial Equivalence Determinations Document issued on: March 12, 2000 U.S. Department Of Health And Human Services Food and Drug Administration
More informationGOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE. Working Group Chair: Melissa Torres US Food and Drug Administration
GOOD REGULATORY REVIEW PRACTICES WORKING GROUP UPDATE Working Group Chair: Melissa Torres US Food and Drug Administration GOALS The Good Regulatory Review Practices working group has focused efforts on
More informationIntroduction to HACCP for the Agri Feed/ Food Supply chain
April 2016 Contents 1 What is HACCP?... 2 1.1 HACCP History... 2 1.2 HACCP in the Agri Feed/ Food Supply Chain today... 2 1.3 HACCP Principles... 3 1.4 The Steps in the HACCP Process... 4 2 How HACCP can
More information