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ISO 13485 training and deployment :

Introduction:

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. A successful implementation will demonstrate a company's ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices

Module 1: General Awareness Training 2 Days

To provide overview of ISO 13485:2003. Focus will be on following:-

  • History of ISO 13485 :2003

  • ISO 9001 QMS Model

  • Exposure to Regulatory requirements

  • Exposure to different categories of Process

  • Effectiveness and efficiency of the process

  • Overview of Requirements of ISO 13485

  • Overview to Good Manufacturing Practices (GMP)

  • Exposure to Corrective and preventive actions concepts

  • Exposure to Continual improvement concept

  • Requirements of Certification


Objectives of the training

Make participants to understand the requirements of ISO 13485:2003. To make aware of regulatory requirement and GMP requirements and how it impact the Certification


Module 2: Documentation and Implementation Training 3 Days

To provide in depth knowledge on ISO 13485 and GMP & Regulatory requirements in order to Establish and document ISO 13485 Quality management System in the organization. Focus will be on following:-

  • Understanding the goals & background of ISO 13485

  • Exposure to different categories of Process

  • Effectiveness and efficiency of the process

  • Exposure to Turtle concept and octopus model for defining the process

  • Understanding of ISO 13485 requirements

  • Provide Best-in-Class BMS concepts and approaches

  • To know the importance of Regulatory requirement and GMP Requirements s and how they affect the auditing of ISO 13485:2003

  • Documentation requirements of ISO 13485:2003

  • To know how to upgrade the existing QMS to meet the requirements ISO 13485:2003

  • Over view of GMP and Regulatory requirements

  • Exposure to Document and Record control

  • Exposure to Corrective and preventive actions concepts

  • Exposure to Continual improvement concept

  • ISO 13485 :2003 Certification requirements


Objectives of the training

Make participants to understand the requirements of ISO 13485 and GMP & Regulatory requirements in order effectively document, implement and continually improve the effectiveness of Business Management System


Module 3: Internal Auditor Training 3 Days

Main Highlight of Program:

A unique course designed and offered to train a pool of internal auditors who will be regularly used to measure the system compliance and effectiveness:-


  • Importance of 8 Quality management Principle

  • To recap the understanding of the requirements of the standard.

  • Capturing Regulatory requirements

  • Over view of GMP

  • To provide in-depth knowledge on the requirements of Internal Audit.

  • Documentation requirements of ISO 13485:2003


  • Different types of audit required for ISO 13485 :2003

  • Auditing techniques and the role of Auditors with various practical case studies

  • By the end of the training, the delegates would be able to

  • Plan an audit

  • Perform the audit

  • Identify nonconformities

  • Report nonconformities

  • Verify the effectiveness of corrective actions


Objectives of the training

To improve the audit skills of Internal Auditor in order to conduct effective internal audits and Value added audits in the organization.


Module 4: Lead Auditor Course 5 Days

Main Highlight of Program:

5 Days intensive internationally approved Training Course to provide valuable in depth knowledge on 8 Quality management Principles and Requirements of ISO 13485:2003.This program is done long with our strategic partners. Live case studies on various requirements of ISO 13485:2003 to enhance the Auditing skills of participants.


  • Importance of 8 Quality management Principle

  • To recap the understanding of the requirements of the standard.

  • Capturing Regulatory requirements

  • Over view of GMP

  • To provide in-depth knowledge on the requirements of Internal Audit.

  • Documentation requirements of ISO 13485:2003


  • Different types of audit required for ISO 13485 :2003

  • Auditing techniques and the role of Auditors with various practical case studies

  • By the end of the training, the delegates would be able to

  • Plan an audit

  • Perform the audit

  • Identify nonconformities

  • Report nonconformities

  • Verify the effectiveness of corrective actions

  • Live case studies

  • Exercises

Objectives of the training

The primary objective of this training course is to improve the audit skills of participants in the principles and to auditing for conformance with ISO 13485:2003, including planning and preparation of the audit, audit practices, and reporting audit findings.

Your Benefits from the program

  • To ensure effectiveness and efficiency of the process

  • To understand the roles and responsibilities of Auditor/lead Auditor

  • Able to relate various situations to appropriate requirements of the standard

  • Plan and conduct the second and Third party Audits

  • To conduct value added audit

  • To verify the effectiveness of corrective action

  • By the end of the training, the participants would be able to

  • Plan an audit

  • Perform the audit

  • Identify nonconformities

  • Report nonconformities

  • Verify the effectiveness of corrective actions

Who Should Attend the Course?

  • This course is essential for personnel of all the levels of the organization who have implemented or in the process of implementation of ISO 9001:2008 / those who carry out /plan to carry out/second and third party audit

  • Delegates must have some basic understanding of the content ,applications and implementation of ISO 9001:2008


Why EBS as Training Partner :

  • Highly experienced faculty from Exemplary Business Solutions Pvt. Ltd. will conduct this training program

  • Practical Case studies will be shared in the workshop

  • Practical application of the concept taught in class room

  • The unique blend of our Strategic and Quality Management consultancy services leading to single window solution provider.

  • Expertise in exploring the real issues confronting the business growth and identifying the hidden factory

  • Deep industry experience. We bring deep sector knowledge and informed points of view about the markets and competitors.

  • Client team feel motivated/vibrant after exchanging ideas and solutions with our strategic and quality consultants

  • Multilingual Training

  • Compatible, flexible and customer friendly approach


Module 5: Customized workshop and deployment support for ISO 13485

This is unique model of EBS group. Today every corporate is moving from standard class room training to customized deployment oriented workshop for achieving people involvement and business results to sustain growth and competitive advantage .

We have not provided detailed of our customized approach on our website to maintain confidentiality of our approaches and uniqueness of our solutions.

We will be happy to provide you full detail during our meeting or you can request same to our customer service executive at customerservices@exemplarybusiness.com or info@exemplarybusiness.com




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