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    ISO 13485 LAT - Training Objective

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    documentspm8327
    This document provides information about an ISO 13485 Lead Assessor Course offered by Prinsip Mahir Sdn Bhd. It introduces the course by discussing the importance of medical device safety and the role of ISO 13485. The course objectives are to help participants gain a better understanding of ISO 13485 and its requirements to demonstrate medical device safety. The course content covers topics like quality management systems, ISO 13485 guidance, Malaysian medical device regulations, risk management, auditing standards and procedures, and conducting an audit. The goal is to train individuals to audit medical devices and ensure safety throughout the device lifecycle from design to distribution.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF or read online from Scribd

    ISO 13485 LAT - Training Objective

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    documentspm8327
    162 views2 pages
    This document provides information about an ISO 13485 Lead Assessor Course offered by Prinsip Mahir Sdn Bhd. It introduces the course by discussing the importance of medical device safety and the role of ISO 13485. The course objectives are to help participants gain a better understanding of ISO 13485 and its requirements to demonstrate medical device safety. The course content covers topics like quality management systems, ISO 13485 guidance, Malaysian medical device regulations, risk management, auditing standards and procedures, and conducting an audit. The goal is to train individuals to audit medical devices and ensure safety throughout the device lifecycle from design to distribution.

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    ISO 13485 LAT_Training Objective

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    This document provides information about an ISO 13485 Lead Assessor Course offered by Prinsip Mahir Sdn Bhd. It introduces the course by discussing the importance of medical device safety and the role of ISO 13485. The course objectives are to help participants gain a better understanding of ISO 13485 and its requirements to demonstrate medical device safety. The course content covers topics like quality management systems, ISO 13485 guidance, Malaysian medical device regulations, risk management, auditing standards and procedures, and conducting an audit. The goal is to train individuals to audit medical devices and ensure safety throughout the device lifecycle from design to distribution.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF or read online from Scribd
    Download as pdf
    162 views2 pages

    ISO 13485 LAT - Training Objective

    Uploaded by

    documentspm8327
    This document provides information about an ISO 13485 Lead Assessor Course offered by Prinsip Mahir Sdn Bhd. It introduces the course by discussing the importance of medical device safety and the role of ISO 13485. The course objectives are to help participants gain a better understanding of ISO 13485 and its requirements to demonstrate medical device safety. The course content covers topics like quality management systems, ISO 13485 guidance, Malaysian medical device regulations, risk management, auditing standards and procedures, and conducting an audit. The goal is to train individuals to audit medical devices and ensure safety throughout the device lifecycle from design to distribution.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF or read online from Scribd
    Download as pdf
    of 2

    Prinsip Mahir Sdn Bhd

    (589748-X))
    No 7B, Solok Seri Sarawak 36, Off Jalan Tun Abdul Razak,
    Taman Sri Andalas, 41200 Klang, Selangor Darul Ehsan, MALAYSIA.
    Tel : 03-3323 1126 / 1129 Fax : 03-3323 1192
    www.prinsipmahir.net

    ISO 13485 LEAD ASSESSOR COURSE


    --------------------------------------------------------------------------
    Introduction

    Today medical devices safety is a global concern. Pressure from user, patients, and legislative bodies
    affected the whole chain of medical devices. While we are considering our medical device are safe.
    Several profile cases had underlined the potential danger of devices to users, patients and brand
    value. For this reason manufacturers, distributors and service providers are now concerned more
    about the safety of the devices ever before.

    With the increase in the number of different medical device schemes, developed at Regional level,
    national level, by trade associations, medical device distributors, service providers and manufacturers
    all requiring implementation and certification to ISO 13485:2003 Medical Devices- Quality
    Management Systems to demonstrate devices safety.

    In 2003 the International Organization for Standardization (ISO) has published ISO 13485:2003
    Medical Devices- Quality Management Systems. This system had been developed to aid
    harmonization of approach to managing medical devices safety for all type of organizations that could
    impact on the safety of devices covering from Pre-market, Replacement on Market and Post Market
    phases of the device.

    Course Objective

    In February 2005, a decision was made by the Malaysia Government to regulate medical devices in
    Malaysia. The Ministry of Health Malaysia is responsible to develop and implement a regulatory
    framework for the control of medical devices. The aims of the medical devices regulation are;

    • to protect public health and safety


    • to allow patients for earlier access to new technology for early detection, diagnosis and treatment
    • to facilitate trade and to invigorate the medical devices industry

    Voluntary Registration of Medical Devices Establishments (MeDVER) registration of establishments


    and their medical devices is considered to be the most basis level of regulatory control of devices in
    the market. It will identify the devices, the responsible party and will facilitate any regulatory activity.

    This training is designed for all medical devices parties to gain a better understanding on ISO
    13485:2003 with regards to National / International requirements to demonstrate devices safety. In
    addition, the concept of application of risk management to medical devices is introduced and how it
    adds value to the organization. Internal Audit skills will be taught with reference to ISO 19011:2002
    to ensure system conformance to ISO 13485:2003 and National / International requirements. Upon
    completion of this training, individual will be able to exercise enforcement on devices safety through
    effective auditing from designing, to manufacturing and until distributing.
    Prinsip Mahir Sdn Bhd
    (589748-X))
    No 7B, Solok Seri Sarawak 36, Off Jalan Tun Abdul Razak,
    Taman Sri Andalas, 41200 Klang, Selangor Darul Ehsan, MALAYSIA.
    Tel : 03-3323 1126 / 1129 Fax : 03-3323 1192
    www.prinsipmahir.net

    ISO 13485 LEAD ASSESSOR COURSE


    --------------------------------------------------------------------------
    Course Content

    The scope of the medical devices auditing will apply to the whole life cycle of the device ranging from
    the pre-market phase, the placement-on-market phase and the post-market phase. Regulation
    activities to be covered are design and manufacturing, labeling, advertising and sales, use,
    maintenance and disposal.

    • Introduction to Quality Management System


    • ISO 13485 guidance and conformance standard
    • Recognize Malaysia Medical Devices Regulation and estimate future inquiries
    • Application of ISO 14971:2007 principles and method
    • Introduction to Quality Management System (QMS) audit
    • Auditor qualities and responsibilities
    • Audit planning and preparation
    • Managing an audit
    • Conducting the audit
    • Reporting the audit findings with non conformities categorization
    • Examination

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