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ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, 2/Ed > 의용공학

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ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, 2/Ed
판매가격 150,000원
저자 Itay Abuhav
도서종류 외국도서
출판사 CRC
발행언어 영어
발행일 2018-5
페이지수 878
ISBN 9781138039179
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    도서 상세설명

    Table of Contents

    Scope, Normative References. Terms and Definitions. Context of the Organization. Understanding the Organization and its Context. Understanding the Needs and Explanations of Interested Parties. Determining the Scope for the Quality Management System. Quality Management System and its Processing. Leadership. General Customer Focus. Policy. Establishing the Quality Policy. Communicating the Quality Policy. Organizational Roles, Responsibilities and Authorities. Planning. Actions to Address Risks and Opportunities. Qualty Objectives and Planning to Achieve Them. Planning of Changes. Support. Resources. General. People. Infrastructure. Environment for the Operation of Processes. Monitoring and Measuring Resources. Organizational Knowledge. Competence. Awareness. Communication. Documented information. General. Creating and Updating. Control of Documented Information. Operation. Operational Planning and Control. Requirements for Products and Services. Customer Communication. Determining the Requirements for Products and Services. Review of Their Requirements for Products and Services.Changes to Requirements for Products and Services. General. Design and Development Planning. Design and Development Inputs. Design and Development Controls. Design and Development Outputs. Design and Development Changes.
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