Mdd Compliance Using Quality Management Techniques
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| Author | : Ray Tricker |
| Publisher | : Taylor & Francis |
| Total Pages | : 608 |
| Release | : 2012-04-27 |
| Genre | : Business & Economics |
| ISBN | : 1136378758 |
The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal "Eurospeak" into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 786 |
| Release | : 2012-08-21 |
| Genre | : House & Home |
| ISBN | : 0415526876 |
Now in its third edition, this book is a complete guide to the requirements of the 17th Edition of the IEE Wiring Regulations (including Amendment no. 1), BS 7671 and Part P of the Building Regulations. Wiring Regulations in Brief explains complex IEE Wiring Regulations in plain English. Organized by areas of working practice, readers can quickly lay their hands on whatever they need to know, from any section of the regulations. The book also incorporates requirements from other regulations and standards that apply to electrical installation, making it an essential reference for anyone working with UK electrical systems.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 1058 |
| Release | : 2013-05-02 |
| Genre | : Technology & Engineering |
| ISBN | : 113648292X |
The most popular and trusted guide to the building regulations, Building Regulations in Brief is updated regularly to reflect constant changes. Now in its seventh edition, it has sold over 28,000 copies since its first publication in 2003. This new edition includes the latest on all the significant amendments to Building Regulations, Planning Permission and the Approved Documents that occurred in October 2010 and includes changes to Parts F and L, as well as Approved Documents A, C, and J. There are also changes reflecting the consolidation of the building regulations included. The no-nonsense approach has made it a firm favourite with all involved in the building industry including designers, building surveyors and inspectors, students and architects. A ready reference giving practical information, it enables compliance in the simplest and most cost-effective manner possible. Building Regulations in Brief cuts through the confusion to explain the meaning of the regulations, their history, current status, requirements, associated documentation and how local authorities view their importance, as well as emphasizing the benefits and requirements of each regulation. It's an essential purchase for anyone needing to comply with the building regulations.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 614 |
| Release | : 2014-01-21 |
| Genre | : Business & Economics |
| ISBN | : 1134504373 |
Small businesses face many challenges today, including the increasing demand by larger companies for ISO compliance. Compliance is a challenging task for any organisation and can often be time consuming and costly, particularly for small businesses who are unlikely to have quality assurance experts on the payroll. However, it is still possible to achieve compliance without the need for expensive consultancy or training that takes you out of the office! Ray Tricker has already guided hundreds of businesses through the challenge and this, the 5th edition of his life-saving ISO guide, has been rewritten and refined following 5 years' field use of working with the standard. The one area that an organisation (particularly a small business) always wants to know is ‘how much is it going to cost to implement and operate a QMS compliant with ISO 9001: 2008 – and is it going to be worth the trouble?!’ Due to popular demand, Edition 5 now includes a brand new chapter on the cost of implementing ISO 9001:2008. This edition provides: Relevant examples that put the concepts and requirements of the standard into a real-life context Down to earth explanations to help you determine what you need to work in compliance with and/or achieve certification to ISO 9001:2008 An example of a complete, generic, Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Work Instructions Access to a free, software copy of this generic QMS files (available from the author) to give you a starting-point from which to develop your own documentation. ISO 9001:2008 is the most widely followed quality management standard and the rewards can be great, opening up new business opportunities, as well as bringing real improvements to your processes and outputs.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 302 |
| Release | : 2019-11-05 |
| Genre | : Business & Economics |
| ISBN | : 1000728129 |
This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 633 |
| Release | : 2016-10-04 |
| Genre | : Business & Economics |
| ISBN | : 1317685679 |
Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards. ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes: down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001:2015; a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards; a detailed description of the structure of ISO 9001:2015 and its compliance with Annex SL; coverage of the new requirements for Risk Management and Risk Analysis; a guide to the costs involved in implementing ISO 9001:2015 and advice on how to control costs; an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation. This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 341 |
| Release | : 2006-08-11 |
| Genre | : Business & Economics |
| ISBN | : 1136391088 |
In order to meet the recommendations, requirements and specifications of ISO 9001:2000, organisations must undertake an audit of their own quality procedures and those of their suppliers. Likewise, when supplying ISO 9001:2000 accredited customers, suppliers must be prepared to undergo a similar audit. Revised, updated and expanded, ISO 9001:2000 Audit Procedures describes the methods for completing management reviews and quality audits, and outlines the experiences of working with 9001:2000 since its launch in 2000. It also includes essential new material on process models, generic pocesses, the requirements for mandatory documented procedures, and detailed coverage of auditors questionnaires.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 540 |
| Release | : 2005 |
| Genre | : Business & Economics |
| ISBN | : 075066617X |
Small and medium-sized companies face many challenges today including the demand by larger customers for ISO 9000 compliance. Four years into the current version of ISO 9000, the new edition of this life-saving book incorporates the hard-won field experience of actually working with the standard. Along with a thoroughly updated and customisable generic Quality Manual with audit checklists for developing a complete Quality Management System, the book provides valuable advice on: Compatibility and Inter-Relationship between other Management Standards; Basic Requirements to Set Up an Integrated Management System; and, The Eight Principles of Management, among others.
| Author | : Rozz Algar |
| Publisher | : Routledge |
| Total Pages | : 934 |
| Release | : 2010-05-04 |
| Genre | : Technology & Engineering |
| ISBN | : 1136367209 |
Scottish Building Standards in Brief takes the highly successful formula of Ray Tricker's Building Regulations in Brief and applies it to the requirements of the Building (Scotland) Regulations 2004. With the same no-nonsense and simple to follow guidance but written specifically for the Scottish Building Standards it's the ideal book for builders, architects, designers and DIY enthusiasts working in Scotland. Ray Tricker and Roz Algar explain the meaning of the regulations, their history, current status, requirements, associated documentation and how local authorities view their importance, and emphasises the benefits and requirements of each one. There is no easier or clearer guide to help you to comply with the Scottish Building Standards in the simplest and most cost-effective manner possible.
| Author | : Ray Tricker |
| Publisher | : Routledge |
| Total Pages | : 283 |
| Release | : 2016-06-23 |
| Genre | : Business & Economics |
| ISBN | : 1317685628 |
ISO 9001: 2015 In Brief provides an introduction to quality management systems for students, newcomers and busy executives, with a user friendly, simplified explanation of the history, the requirements and benefits of the new standard. This short, easy-to-understand reference tool also helps organisations to quickly set up an ISO 9001:2015 compliant Quality Management System for themselves at minimal expense and without high consultancy fees. Now in its fourth edition, ISO 9001:2015 In Brief consists of a number of chapters covering topics like: What is Quality? – An introduction to the requirements and benefits of quality, quality control and quality assurance What is a QMS? – The structure of a Quality Management System and associated responsibilities. Who produces Quality Standards? – An opportunity to see how interlinked the various Standards Bodies are today. What is ISO 9001:2015? - The background to this particular standard, how it has grown and developed over the years and what ‘Annex SL’ is all about. What other standards are based on ISO 9001:2015? – Details of other standards that replicate or are broadly based on ISO 9001:2015. What to do once your QMS is established – Process improvement tools, internal auditing and the road to ISO 9001:2015 certification. This is supported by: Annex A – A summary of the requirements of ISO 9001:2015 - including an overview of the content of the various clauses and sub clauses, the likely documentation required and how these would affect an organization. A cross-reference to the previous ISO 9001:2008 Clauses is also provided as well as a complete bibliography and glossary.
