Foundation Training on ISO 13485:2016 Awareness
What you'll learn
- Features, applicability and key elements of ISO 13485 standard, including the high-level structure and framework of the ISO 13485 standard.
- The benefits of implementing ISO 13485:2016.
- The quality management principles of ISO 13485 standard.
- The requirements of ISO 13485:2016 standard for system compliance and certification.
- Documentation structure for effective system implementation and ISO 13485 certification.
- The essential steps involved in obtaining ISO 13485 certification for your organization.
Requirements
- No specific prerequisites or requirements are necessary.
- Familiarity with ISO standards is helpful, but not essential.
- Understanding common terms frequently used in ISO management system standards can be beneficial.
Description
ISO 13485 Awareness training course will fulfill your need to know and learn about ISO 13485 standard and the medical devices quality management system. This training course is designed to help participants know what exactly is ISO 13485 standard, where it is applicable and what are the principles on which this standard is based. It helps to understand the relationship between ISO 13485 and ISO 9001 quality management system standards. The course will also help you know ISO 13485 quality management system requirements and the steps need to be taken by medical device companies for ISO 13485 certification. Additionally this course will be helpful to understand the meaning of documented information, the documents and records requirements of ISO 13485 standard and the key points to consider for control of quality management system documented information. All these things will be briefly but effectively covered in the ISO 13485 awareness training course. The training will provide a genuine knowledge of ISO 13485 documented information, certification process steps and ISO 13485 Medical Device Quality Management System requirements. This training will equip you with in-depth knowledge that can be immediately applied to thrive in today’s competitive medical device industry.
The ISO 13485 training program includes the following key elements:
Overview of ISO 13485:2016 Medical Devices Quality Management System
ISO 13485:2016 Requirements
Control of Documents and Records
Steps for ISO 13485:2016 QMS Installation & Certification.
Who this course is for:
- Employees in medical device organizations
- Managers of such organizations
- Entrepreneurs
- Graduate students or People looking to start a new career
- ISO 13485 Quality management consultants
Instructor
- 3.9 Instructor Rating
- 384 Reviews
- 2,805 Students
- 28 Courses
Punyam Academy Pvt. Ltd. is a certified training provider company, which offers various E-learning Training Courses, Documentation and ppt presentations, E-books and KPO services for third party and customer audits. We are a leading name in E-learning, training and certification for ISO standards and all other types of management system standards. Punyam Academy specializes in a complete range of courses on awareness, lead implementer, auditor and lead auditor courses based on ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, ISO 27001, ISO 50001, ISO 13485, ISO 20000, ISO/IEC 17024, ISO 17034, ISO 22301, NABH and other management system standards as well as training courses for Certified Calibration Engineer and management functional area improvement.
Our management have rich experience of various ISO system certification consultancies in pas tin Atira. At present our e learning courses are sold in more than 70 countries. Our team has conducted in-house and public training programs as well as online corporate training sessions in. Our courses are certified by Exemplar Global and the CPD, which are leading companies in the USA and the UK, respectively.