Implementing Quality Management Systems In National Regulatory Authorities PDF Download
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Author | : |
Publisher | : World Health Organization |
Total Pages | : 64 |
Release | : 2021-06-23 |
Genre | : Medical |
ISBN | : 9240022376 |
Download Implementing quality management systems in national regulatory authorities Book in PDF, ePub and Kindle
Author | : world health organization |
Publisher | : |
Total Pages | : 0 |
Release | : 2022 |
Genre | : |
ISBN | : |
Download Implementing Quality Management Systems in National Regulatory Authorities: Examples and Practices Book in PDF, ePub and Kindle
Author | : Ilkka Juuso |
Publisher | : CRC Press |
Total Pages | : 331 |
Release | : 2022-03-20 |
Genre | : Business & Economics |
ISBN | : 1000550680 |
Download Developing an ISO 13485-Certified Quality Management System Book in PDF, ePub and Kindle
Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 272 |
Release | : 2023-11-14 |
Genre | : Medical |
ISBN | : 9240076964 |
Download Manual for performance evaluation of regulatory authorities seeking designation as WHO-listed authorities Book in PDF, ePub and Kindle
This manual provides operational and technical details for the performance evaluation (PE) exercise that must be conducted for a regulatory authority (RA) to achieve listing as a WHO-listed authority (WLA) in relation to each regulatory function. The PE manual should be read in conjunction with the Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities (“The Operational Guidance”). For the purposes of this document the term regulatory authority (RA), unless otherwise stated, may refer to either a national regulatory authority (NRA) or a regional regulatory system (RRS). The basis for designation as a WLA is provided by the Global Benchmarking Tool (GBT), which is complemented by a series of PE activities designed to establish a detailed picture of how the regulatory system performs on relevant regulatory processes, including how consistently it adheres to quality procedures and how well it delivers the desired regulatory outputs in accordance with good regulatory practices.
Author | : |
Publisher | : World Health Organization |
Total Pages | : 350 |
Release | : 2021-05-10 |
Genre | : Medical |
ISBN | : 9240020241 |
Download WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems of medical products, revision VI Book in PDF, ePub and Kindle
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 345 |
Release | : 2020-04-21 |
Genre | : Medical |
ISBN | : 9240001824 |
Download WHO Expert Committee on Specifications for Pharmaceutical Preparations Book in PDF, ePub and Kindle
Author | : |
Publisher | : World Health Organization |
Total Pages | : 355 |
Release | : 2021-04-08 |
Genre | : Medical |
ISBN | : 9240022805 |
Download WHO Drug Information Book in PDF, ePub and Kindle
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 1354 |
Release | : 2024-01-31 |
Genre | : Business & Economics |
ISBN | : 9240086080 |
Download Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection Book in PDF, ePub and Kindle
The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
Author | : Magd, Hesham |
Publisher | : IGI Global |
Total Pages | : 378 |
Release | : 2021-09-17 |
Genre | : Education |
ISBN | : 1799880877 |
Download Global Perspectives on Quality Assurance and Accreditation in Higher Education Institutions Book in PDF, ePub and Kindle
Quality accreditation in higher education institutions (HEIs) is currently a buzzword. The need to maintain high-quality education standards is a critical requirement for HEIs to remain competitive in the market and for government and regulatory bodies to ensure the quality standards of programs offered. From being an implicit requirement that is internally addressed, quality assurance activities become an explicit requirement that is regularly audited and appraised by national and international accreditation agencies. HEIs are voluntarily integrating quality management systems (QMS), institutional and program-specific, in response to the political and competitive environment in which it exists. Through its higher education department or by creating non-profitable accreditation bodies, many governments have implemented a quality framework for licensing HEIs and invigilates its adherence based on which accreditation statuses are granted for HEIs. Global Perspectives on Quality Assurance and Accreditation in Higher Education Institutions provides a comprehensive framework for HEIs to address quality assurance and quality accreditation requirements and serves as a practical tool to develop and deploy well-defined quality management systems in higher education. The book focuses on the critical aspects of quality assurance; the need to develop a concise and agile vision, mission, values, and graduate attributes; and to develop a system that effectively aligns the various activities of the HEI to the attainment of the strategic priorities listed in the institutional plans. The chapters each cover the various facets of the quality assurance framework and accreditation agencies' requirements with practical examples of each. This book is useful for HEI administrators, quality assurance specialists in HEIs, heads of academic departments, internal auditors, external auditors, and other practitioners of quality, along with stakeholders, researchers, academicians, and students interested in quality assurance and accreditation in higher education.
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 350 |
Release | : 2023-05-26 |
Genre | : Medical |
ISBN | : 9240074481 |
Download WHO Expert Committee on Biological Standardization Book in PDF, ePub and Kindle
The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.