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Objectives of Training
ISO 14001:2015 is an Environmental Management System Standard. Achieving a balance between the environment, society and the economy are considered essential to meet the needs of the present without compromising the ability of future generations to meet their needs. Sustainable development as a goal is achieved by balancing the three pillars of sustainability. Societal expectations for sustainable development, transparency and accountability have evolved with increasingly stringent legislation, growing pressures on the environment from pollution, inefficient use of resources, improper waste management, climate change, degradation of ecosystems and loss of biodiversity. This has led organizations to adopt a systematic approach to environmental management by implementing environmental management systems with the aim of contributing to the environmental pillar of sustainability. 0.2 Aim of an environmental management system The purpose of this International Standard is to provide organizations with a framework to protect the environment and respond to changing environmental conditions in balance with socioeconomic needs. It specifies requirements that enable an organization to achieve the intended outcomes it sets for its environmental management system. A systematic approach to environmental management can provide top management with information to build success over the long term and create options for contributing to sustainable development by:
- Protecting the environment by preventing or mitigating adverse environmental impacts
- Mitigating the potential adverse effect of environmental conditions on the organization
- Assisting the organization in the fulfillment of compliance obligations
- Enhancing environmental performance
- Controlling or influencing the way the organization’s products and services are designed, manufactured, distributed, consumed and disposed by using a life cycle perspective that can prevent environmental impacts from being unintentionally shifted elsewhere within the life cycle
- Achieving financial and operational benefits that can result from implementing environmentally sound alternatives that strengthen the organization’s market position
- Communicating environmental information to relevant interested parties
- This international standard, like other international standards, is not intended to increase or change
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 effective.
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
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.