ISO 13485:2016
In March 2016 the new edition of ISO 13485 was published. Industry is now implementing this Quality Management System due to the expectations from worldwide authorities. There is a handbook, a guidance document, replacing the TR 14969. The handbook will be covered as well. We will also discuss the benefits with ISO 13485 versus the MDSAP. Interface standards will be discussed.
About About ISO 13485:2016
Goal:
To give an understanding of the full standard. You should be qualified as internal auditor in ISO 13485 after the course.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Anette is also a member of the new task force for Annex L (high level structure).
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Program:
Two days course including a written examination (multiple choice questions)
Day 1:
Background and introduction to ISO 13485
The chapters 4 – 7.2 with exercises and workshops within policy, objectives and competence profiles. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.
Day 2:
Continue chapter 7 and 8 with workshops within the CAPA process. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.
Examination.
Venue:
The training is held in the area of Copenhagen, Denmark
About About ISO 13485:2016
Goal:
To give an understanding of the full standard. You should be qualified as internal auditor in ISO 13485 after the course.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Anette is also a member of the new task force for Annex L (high level structure).
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Program:
Two days course including a written examination (multiple choice questions)
Day 1:
Background and introduction to ISO 13485
The chapters 4 – 7.2 with exercises and workshops within policy, objectives and competence profiles. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.
Day 2:
Continue chapter 7 and 8 with workshops within the CAPA process. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.
Examination.
Venue:
The training is held in the area of Copenhagen, Denmark