Category: Uncategorized

Quality Management Systems – Requirements for Regulatory Purposes

Overview

ISO 13485 sets regulatory requirements or, customer specific requirements (if specified) for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems.

ISO 13485 is a quality management system designed specifically for the Medical Devices industry regardless of the type or size of the organization.

The ISO 13485 standard follows the ISO 9001 process approach to quality management and adds additional requirements like compliance with statutory and regulatory requirements. It focuses on what manufacturers must do to provide safe and effective medical devices to the end users.

For more information on ISO 13485 certification, Training contact any of our branch near you or call us now +91-9723766248 or email info@eurotechworld.net

Benefits of ISO 13485 to an organization:

The benefits of ISO 13485 Certification include:

• Demonstration of regulatory compliance and more effective risk management.
• Compliance to national or international regulatory requirements.
• Certification also confirms to customers, suppliers and other stakeholders that the organization is in a state of control over its operations.
• Provides assurance that appropriate regulatory requirements are implemented within your organizational processes
• Provides confidence that best practice validation and GMP have been implemented and evaluated
• Provides confidence of quality risk management and good manufacturing practices throughout the medical device product life cycle

ISO 13485:2016 Revision

The International Organization for Standardization (ISO) published the updated ISO 13485 medical devices quality management systems standard on March 1, 2016. ISO 13485:2016 can be used by organizations involved in the production, post-production, storage, distribution, installation, servicing, final decommission and disposal of medical devices. There is also a provision for services associated with the medical device industry.

Few highlights from the 2016 version:

• Improved alignment with regulatory requirements & enhanced transparency of requirements.
• Expansion of the standard’s applicability to include all organizations involved in the life cycle of the product.
• Greater focus on post-market surveillance (including complaint handling)
• More emphasis on implementing the appropriate infrastructure, particularly for the production of sterile medical devices
• and many More..

Understanding, Implementing & monitoring ISO 13485

Every Organization involved in the production, storage, distribution, installation, servicing, final decommission and disposal of medical devices needs to have ISO 13485 certification in order to sell their products to various countries as a mandatory requirement.

Here, it becomes very important to understand the ISO 13485. We Eurotech Assessment and Certification Pvt. Ltd. bring different level of ISO 13485 Training Courses i.e.

• Awareness Training for professionals and organization are new to ISO 13485, didn’t have implemented ISO 13485 in place at the moment and looking for formal training to enhance the understanding of ISO 13485.
• Internal Auditor Training for the professionals and organizations have already implemented or at the early stages of implementation, aiming to develop management system monitoring team in house, clearing any doubts regarding, interpreting Standard’s requirements, documentation, Audits etc
• Lead Auditor Training courses for those who have already implemented ISO 13485 and aim to enhance the performance of the Quality management system in order to ensure that they have effective system in-place, ensuring the compliance to Regulations and national and international standards.
• Transition Training Course for the professionals and organizations looking to update their knowledge and already implemented system to recently published standard. ISO 13485:2016 is the latest version of Medical Devices Standard.

Kindly Visit Training Courses page for complete details of required training course.

About Course:

This Classroom Based two full days course aims to provide participants, the skills required to conduct internal audits, using interactive training by experienced medical device lead auditors for ISO 13485.

Delegates will learn the principles and practices of effective quality management system, process audit in accordance with the ISO 13485 and ISO 19011.

Course delivery will comprise presentations, workshops, and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 certified industries.

Course type: Classroom Based

Timing: 16 Hours/ Two Day

Assessment By: Examination

Learning Objectives:

* Understanding the ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide

* Understanding the auditing principles with ref to ISO 19011

* Understanding how to Plan an internal audit and the responsibilities of an Auditor

* Types of audit, Checklist development & internal audit objectives

* How to conduct opening and closing meetings

* Conduct an audit based on process identification

* How to write nonconformities & Audit report, follow-up on corrective actions

* Medical devices, quality and auditing terminology

* Structure & intent of the medical devices standard ISO 13485:2016

* Planning, preparation and management of audits

* Internal audit scope and criteria

* The audit process

*Roles and responsibilities of the internal auditor

* Interviewing skills

Who should attend?

*Medical device quality professionals having knowledge of quality management systems and ISO 13485

*Management Representatives

*Internal auditors

*Individual Consultants

What you will get?

All delegates will get:

*Hard copy of Study Material (includes copy of ISO 13485 and ISO 19011 Standards subject to return to EACS on completion of Course)

*Notes for Training

*Lunch & Refreshments (as per season)