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Effective Implementation Techniques | ISO 13485:2016

Effective Implementation Techniques
ISO 13485:2016

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QSE: 27+ Years of Experience in Consulting, Auditing, & Training

Objectives of Training

ISO 13485:2016 is a standard covering the requirements for Medical Devices whether in contact with Humans or animals or without any contact. The medical devices are said to be in contact if the device remains in contact with the human or animal for more than 24 hours. These could be like dental implants or pacemakers, and other similar aids. Whereas items like crutches, wheelchairs, dental chairs etc. Are considered as non-contact medical devices since the contact with these items has no bearing on the health of Humans or animals and is not continuous.

This one-day interactive session provides clear concepts, terminology and fundamentals to effectively implement the standard. Cost effective implementation techniques and process approach in conducting audits for bottom-line results, are emphasized.

It may be remembered that although this standard was revised in 2016 the standard, the technical committee of writers for ISO 13485:2016 have chosen not to revise this standard for high level 10 element structure in line with ISO 13485:2016, instead they have chosen to continue with ISO 9001:2008 as their base principle of quality standards. Consequently, the standard has retained the need for producing documented processes which is not the case with ISO 13485:2016.

Including the Medical Devices Quality Management System is a thoughtful selection by any management, based on their needs. Objectives, the type of products provided, the processes required, size and structure of the organization. The standard does not insist that all managements follow a uniform quality management system, nor a uniform documentation system.

Finally, the course emphasizes the effective methods of documented information and the advantages of a simplified and comprehensive one level documentation. This one level documentation is an evidence-based system which offers proof of implementation for the standard’s requirements. This 1-day on site implementation training course includes explanations on Terms, Concepts and Principles covered in revised ISO 13485:2016 standard.

  • Practitioners of Quality Management System as a part of certification to ISO 13485:2016
  • Persons interested in becoming Trained Internal auditors for ISO 13485:2016 Standard
  • ISO Manager or Quality Manager Designates
  • Quality Assurance Managers who are responsible for implementing ISO 13485:2016 quality management systems in their facilities
  • Internal manufacturing and nonmanufacturing process knowledge
  • Intention to improve and passion to work with people
  • Working knowledge about ISO 13485:2016 desirable but not essential
  • Working knowledge about nature of products and levels of application in use, in terms of extent of contact with Humans or animals
  • Working knowledge about regulatory requirements about their products and services
  • ISO 13485:2016 and related standards for exclusive use in training program
  • Cross Reference Table between ISO 13485:2016 and ISO 9001:2008
  • Student Workbook
  • Intent Comprehension of the Standard
  • Terms, Definitions, Concepts and Principles
  • Format of new 13485:2016 Standard
  • Direct comparison of ISO 9001:2008 to ISO 13485:2016
  • Major changes from previous revision, differences, and relationships.
  • Understand Linkages between 13485 and cGMPs
  • Process Approach and System Approach concepts
  • Understand the role of management during Implementation
  • Powerful Implementation Techniques to minimize implementation difficulties
  • This 1- day course involves state of the art audio visual presentation,
  • Training through interactive lectures and Quiz at the end of the day
  • The course would be interactive and provides for question/ answer session each day and methods to interpret for normal day to day work
  • Student materials with space for making notes and using during the question answer session
  • Provides explanation on the templates and forms to be used
  • Discusses the advantages of using comprehensive single level simplified documentation system
  • Discusses all the documented processes required for certification
  • Participants learn how to apply the process approach in auditing and leave the training with perfect templates to apply a process approach in auditing
  • Participants fully understand Risk Based Thinking (RBT) and leave with an effective tool to apply this concept and learn how to list, mitigate and assess Risk to realize the desired results
  • Learning how to develop simplified documentation system is another take away to the attendees along with a clear understanding of newly introduced term entitled documented information
  • With this training, the participants learn the intent of ISO 13485:2016 standard
  • Participants learn critical terms, concepts and principles and can apply these in auditing to maximize audit effectiveness
  • Participants learn the techniques for writing documented processes
  • ISO 13485 allows your organization to meet the customer requirements in the production of medical equipment
  • ISO 13485:2016 helps you to understand and meet regulatory conditions and reporting conditions
  • Training on ISO 13485 explains the need and importance of sterilizing techniques for medical devices in contact with humans or animals
  • Participants benefit by understanding the intent of the standard and the techniques of using Medical Devices Quality Management Systems for continual improvement of their products and services
  • Organizations benefit by understanding the standard to use as a powerful marketing tool
  • Provides necessary ideas to standardize quality management in the medical equipment fields.
  • Critical in providing a competitive edge for your organization
  • Students get additional points to mention on their resume

This intensive, one -day course presents an in-depth analysis of the ISO 13485:2016 standard requirements.

This interactive course is highly motivational. The course not only covers the entire intent of the international standard ISO 13485:2016 but also provides clarifications required to explain terms principles and concepts involved in the standard.

Participants will learn and develop implementing skills to function as management review team members.

After this training one can assist organizations in implementing the standard more effectively.

During this course QSE provides a summary at the end of the day to help participants recap what they learned during the day

There will be a quiz at the end of each day to help participants understand the gist of the course covered for the day.

  • Please send a proposal request
  • Maximum permissible participants in each session not to exceed 15
  • One day of instruction, discussion, and quiz


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Frequently Asked Questions​

Trainer is a highly experienced lead auditor. He is a member of ISO/USTAG TC 176 and ISO/US TAG TC 207 the technical committees responsible for writing the ISO 9001 and ISO 14001 standards. He has over 40 years’ experience in the field of quality and is in consulting for last 27 years in medical device quality management systems

ISO 9001 is the basic Quality standard and ISO 13485 append it with additional requirements for medical devices. ISO 9001:2008 is applicable for ISO 13485:2016.

QSE has a unique, comprehensive, single level, simplified documentation system which permits additional of other standards with minimal addition of documentation. The systems developed by QSE are very lean, easily understood and highly manageable.

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Bhaskar Kotte

Baskar Kotte

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