MDD Compliance Using Quality Management Techniques [NOOK Book]

Overview

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...
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MDD Compliance Using Quality Management Techniques

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Overview

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

Audience: Professional market - Medical appliance users and manufacturers - e.g. dental laboratory owner or laboratory equipment manufacturer, quality managers, engineers, production managers/engineers. Student market - Dental technologist courses used by the Institute of Quality Assurance, Health and Safety Courses.

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Editorial Reviews

Booknews
The Medical Devices Directive (MDD) passed by the EEC in June 1998 requires manufacturers of medical devices and/or associative equipment to have in place a fully auditable quality management system. This guide assists small and medium sized in meeting this requirement, and also can be useful for ISO 9000 quality certification. It describes the 20 elements that make up ISO 9001:1994 and the additional quality management requirements which are specifically required to comply with MDD. The author provides a purpose designed, generic quality manual consisting of quality policies, quality procedures and work instructions for companies to use as a template. The CD-ROM contains a copy of the example quality manual. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

  • ISBN-13: 9781136378751
  • Publisher: Taylor & Francis
  • Publication date: 4/27/2012
  • Sold by: Barnes & Noble
  • Format: eBook
  • Pages: 608
  • File size: 10 MB

Meet the Author

Ray Tricker is the Principal Consultant of Herne European Consultancy Ltd - a company specialising in ISO 9000 Management Systems - and is also an established author. He served with the Royal Corps of Signals (for a total of 37 years) during which time he held various managerial posts culminating in being appointed as the Chief Engineer of NATO's Communication Security Agency (ACE COMSEC). Most of Ray's work since joining Herne has centred on the European Railways. He has held a number of posts with the Union International des Chemins de fer (UIC) (e.g. Quality Manager of the European Train Control System (ETCS)) and with the European Union (EU) Commission (e.g. T500 Review Team Leader, European Rail Traffic Management System (ERTMS) Users Group Project Co-ordinator, HEROE Project Co-ordinator) and currently (as well as writing books!) he is busy assisting small businesses from around the world produce their own auditable Quality and/or Integrated Management Systems to meet the requirements of ISO 9001:2008, ISO 14001 and OHSAS standards. He is also a UKAS Assessor for the assessment of certification bodies for the harmonisation of the trans-European high speed railway network.

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Table of Contents

Part One: The Medical Devices Directive: Background; The Medical Devices Directive; Aim of the MDD; Structure of the MDD; MDD - Basic principles; The Requirements of the Council Directive; Essential Requirements; Gaining MDD Accreditation; Annexes where a QMS is directly required for MDD compliance; Annex where a QMS is indirectly required for compliance; Classification criteria; Clinical Evaluation; Criteria to be met for the designation of Notified Bodies. Part Two: Quality Specifications and Requirements: What is quality? The demand for standardization of Quality Management Systems; Interoperality of standards; ISO 9000:1994; Choosing the relevant part of ISO 9000:1994; QS 9000; Assistance in the UK for obtaining a QM System; Assistance in setting up a QM System in America; ISO 14 000; EMAS. Part Three: ISO 9000:1994 and the MDD Requirements: Management responsibility; Quality Management System; Contract review; Design control; Document and data control; Purchasing; Customer supplied product; Product identification and traceability; Process control; Inspection and testing; Inspection, measuring & test equipment; Inspection and test status; Control of non-conforming product; Corrective action; Handling, storage, packaging and delivery; Quality records; Internal quality audits; Training; Servicing; Statistical techniques. Part Four: Quality Management System Requirements: QMS principles; Basic requirements of a QMS; Quality control and quality assurance; Quality Assurance during a product's life cycle; Benefits and costs of quality assurance; Costs of quality failure; QMS reliability; Quality Manual; Quality plan; Quality records; Quality organizational structure; Other considerations. Part Five: Generic MDD Quality Management System: Annex A - Riddiford Medical Devices - Organization and Responsibilities; Annex B - RMD Forms; Annex C - Quality Procedures; Annex D - Work Instructions; Annex E - Cross reference list to ISO 9000:1994.
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