Implementing Quality Management Systems In National Regulatory Authorities
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Implementing Quality Management Systems In National Regulatory Authorities
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-06-23
Implementing Quality Management Systems In National Regulatory Authorities written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-23 with Medical categories.
Implementing Quality Management Systems In National Regulatory Authorities Examples And Practices
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Author : world health organization
language : en
Publisher:
Release Date : 2022
Implementing Quality Management Systems In National Regulatory Authorities Examples And Practices written by world health organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with categories.
Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-14
Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-14 with Medical categories.
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.
Who Expert Committee On Specifications For Pharmaceutical Preparations
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2020-04-21
Who Expert Committee On Specifications For Pharmaceutical Preparations written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-21 with Medical categories.
Achieving Customer Experience Excellence Through A Quality Management System
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Author : Alka Jarvis
language : en
Publisher: Quality Press
Release Date : 2016-07-04
Achieving Customer Experience Excellence Through A Quality Management System written by Alka Jarvis and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-04 with Business & Economics categories.
A case for seeing customer experience, CX, and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies.
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-09 with Law categories.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Guidance On Implementation Of A Quality System In Blood Establishments
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-02-23
Guidance On Implementation Of A Quality System In Blood Establishments written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-23 with Medical categories.
How To Develop And Implement A National Drug Policy
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2001
How To Develop And Implement A National Drug Policy written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Law categories.
A drug policy is a crucial ingredient in every country's national health strategy as it provides a strategic framework to identify goals and commitments. This publication discusses the key components of such a policy. Issues covered include: the selection of essential drugs, affordability; finance and supply; regulation and quality assurance; rational use; research; human resources; monitoring and evaluation.
Joint External Evaluation Of The International Health Regulations 2005 Core Capacities Of Nigeria
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-11-29
Joint External Evaluation Of The International Health Regulations 2005 Core Capacities Of Nigeria written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-29 with Medical categories.
The Joint External Evaluation (JEE) team acknowledges Nigeria for volunteering for a second JEE after holding its first in 2017 and an internal mid-term JEE in 2019. This JEE uses the third edition of the JEE tool. This revised third edition of the tool incorporates relevant lessons from the ongoing COVID-19 pandemic and other public health emergencies. Nigeria’s broad efforts to prepare for and respond to emergencies have clearly facilitated its whole-of government response to the COVID-19 pandemic. The unprecedented nature, magnitude and wide societal impact of the pandemic has led to improvisation and innovation. As a result, emergency risk management stakeholders in Nigeria have been keen to combine the many lessons of the pandemic response – consolidated through intra-action reviews – and to address gaps in IHR core capacities identified through the JEE. The JEE team commends Nigeria for its efforts to monitor and improve health security with openness, transparency and goodwill.