Sign Up
{{userName}}
Account Settings Log Out

ISO 13485:2016

Teacher
Calitop
Category:
ISO Certification

OBJECTIVES:

  • Application of quality management principles in the medical device industry
  • Familiarizing students with the terminology used in quality management standards for medical devices
  • Understanding the additional requirements for a quality management system implemented in medical device manufacturing organizations
  • Understanding of risk management requirements
  • Acquiring skills in identifying and establishing processes and their indicators
  • Preparing the participants to update the QMS with the additional requirements in their own organizations

WHO SHOULD ATTEND

  • Top management
  • Quality managers
  • Managerilor de nivel operaţional
  • Anyone interested in knowing the standards related to the quality management system for medical devices

PREREQUISITE KNOWLEDGE

  • Knowledge of ISO 9001

COURSE AGENDA

  • Identification of customers and products/services provided by student organizations
  • Presentation of terms and definitions (ISO 13485)
  • Comparative presentation of requirements for SMC (ISO 9001 + ISO 13485)
  • Theoretical presentations are alternated with practical examples of how to fulfill the requirements
  • It is exemplified with ways of approaching risk management
  • Conclusions and feedback

1
Presentation

Module 1 Introduction

1
1. Course structure - Specifications
2
2. Course objectives
3
3. Acronyms and abbreviations
4
4. Bibliography

Module 2: ISO 13485 - General

1
1. ISO Family - Current Guidance Guide
2
2. Other standards for QMS
3
3. ISO 13485 – Historic fact
4
4. To whom is it addressed?
5
5. ISO 13485 vs. ISO 9001
6
6. Main differences
7
7. Regulatory requirements
8
8. EU regulatory requirements
9
9. EU directives transposed into laws
10
10. How can we keep informed ?
11
11. Harmonised standards
12
12. Process-based approach
13
13. ISO 13485 - Scope
14
Brief Knowledge Check
5 questions

Module 3: General terms and definitions

1
1. Terms and definitions
2
2. ISO 9000:2015
3
3. ISO 9000:2015
4
4. ISO 9000:2015
5
5. ISO 9000:2015
6
6. ISO 9000:2015
7
7. ISO 13485:2016 and GD 54/2009
8
8. ISO 13485:2016 and GD 54/2009
9
9. ISO 13485:2016 and GD 54/2009
10
10. ISO 13485:2016 and GD 54/2009
11
11. ISO 13485:2016 and GD 54/2009
12
12. ISO 14971:2012
13
13. ISO 14971:2012
14
Brief Knowledge Check
5 questions

Module 4: Context of the organization

1
1. Presentation
2
2. - 4. Context of the organization
3
3. - 4.1 Understanding the organization and the context in which it operates AND 4.1 General requirements 5.6 Management review
4
4. - 4.2 Understanding the needs and expectations of stakeholders AND 4.1 General requirements
5
5 . - 4.3 Determination of the QMS scope AND 1. Scope
6
6. - 4.3 Determination of the scope of the QMS AND 4.2.2 Quality manual
7
7. - 4.4 QMS and its processes AND 4.1 General requirements 4.2.2 Quality manual
8
8. - 4.4 SMC and its processes AND 4.1.2 General requirements
9
9. - 4.4 QMS and its processes AND 4.1.2 General requirements
10
10. - 4.4 QMS and its processes AND 4.1 General requirements
11
11. - 4.4 QMS and its processes AND 4.1.5 General requirements
12
12. - 4.4 QMS and its processes AND 4.1 General requirements
13
Brief Knowledge Check
5 questions

Module 5 Leadership

1
1. Presentation
2
2. - 5.1.1 Leadership and commitment AND 5.1 Management commitment
3
3. - 5.1.1 Leadership and commitment AND 5.1 Management commitment
4
4. - 5.1.2 Customer orientation AND 5.2 Customer orientation
5
5. - 5.2.1 Quality policy setting AND 5.3 Quality policy
6
6. - 5.2.2 Communication of quality policy AND 5.3 Quality policy
7
7. - 5.3 Organisational roles, responsibilities and authorities AND 5.5.1 Responsibility and authority
8
8. - 5.3 Organizational roles, responsibilities and authorities AND 5.4.2 QMS Planning
9
9. - 5.3 Organisational roles, responsibilities and authorities AND 5.5.2 Management representative
10
Brief Knowledge Check
5 questions

Module 6. Planning

1
1. Presentation
2
2. - 6.1 Actions to address risks and opportunities AND 5.4.2 QMS Planning 8.5.3 Preventive actions
3
3. - 6.1 Actions to address risks and opportunities AND 8.5.3 Preventive actions
4
4. - 6.2 Quality objectives and planning for their achievement AND 5.4.1 Quality objectives
5
5. - 6.2 Quality objectives and planning for their achievement AND 5.4.2 QMS Planning
6
6. - 6.3 Change planning AND 5.4.2 QMS Planning
7
Brief Knowledge Check
5 questions

Module 7. Support

1
1. Presentation
2
2. - 7.1.1 Resources – General AND 6.1 Ensuring resources
3
3. - 7.1.3 Infrastructure AND 6.3 Infrastructure
4
4. - 7.1.4 Environment for process operation AND 6.4.1 Work environment
5
5. - 6.4.2 Contamination control
6
6. - 7.1.5.1 Monitoring and measurement resources 7.1.5.2 Traceability of measurement AND 7.6 Control of monitoring and measurement equipment
7
7. - 7.1.5.2 Traceability of measurement AND 7.6 Control of monitoring and measurement equipment
8
8. - 7.1.5.2 Traceability of measurement AND 7.6 Control of monitoring and measurement equipment
9
9. - 7.1.5.2 Traceability of measurement AND 7.6 Control of monitoring and measurement equipment
10
10. - 7.1.6 Organizational knowledge AND 6.2 Human resources
11
11. - 7.2 Competence AND 6.2 Human resources
12
12. - 7.2 Competence AND 6.2 Human resources
13
13. - 7.3 Awareness AND 6.2 Human resources 5.1 Management commitment
14
14. - 7.4 Communication AND 5.5.3 Internal communication
15
15. - 7.5.1 Documented information – General AND 4.2.1 Documentation requirements – General
16
16. - 7.5.1 Documented information – General AND 7.5.1 Documented information – General
17
17. - 4.2.3 Medical device file
18
18. - 7.5.2 Create and update AND 4.2.4 Document control
19
19. - 7.5.3 Control of documented information AND 4.2.4 Document control
20
20. - 4.2.4 Document control
21
21. - 4.2.5 Record control
22
Brief Knowledge Check
5 questions

Module 8. Operation

1
1. Presentation
2
2. 8.1 Operational planning and control AND 7.1 Planning the realization of the product
3
3. Risk Management in ISO 13485
4
4. 8.1 Operational planning and control AND 7.1 Planning the realization of the product
5
5. 8.1 Planning and operational control AND 7.1 Product realization planning 4.1 General requirements
6
6. 8.2.1 Communication with the customer AND 7.2.3 Communication
7
7. 8.2.2 Determination of requirements for prod. & services AND 7.2.1 Determination of product requirements
8
8. 8.2.3 Analysis of the requirements for the prod. & services AND 7.2.2 Analysis of product requirements
9
9. 8.2.3 Analysis of the requirements for the prod. & services AND 7.2.2 Analysis of product requirements
10
10. 8.3.1 Design and development of the prod. & services - General AND 7.3.1 Design and development - General
11
11. 8.3.2 Design and development planning (P&D) AND 7.3.2 Design and development planning
12
12. 8.3.3 Input elements of the P&D AND 7.3.3 Input elements of design and development
13
13. 8.3.4 Controls of the P&D AND 7.3.5 Design and development analysis
14
14. 8.3.4 P&D controls AND 7.3.6 Verification of design and development
15
15. 8.3.4 P&D controls AND 7.3.7 Validation of design and development
16
16. 7.3.7 Validation of design and development
17
17. 8.3.5 Output elements of P&D AND 7.3.4 Output elements of design and development
18
18. 7.3.8 Transfer of design and development
19
19. 8.3.6 Changes to P&D AND 7.3.9 Control design and development changes
20
20. 7.3.10 The design and development file
21
21. 8.4.1 Control of external processes, products and services - General AND 7.4.1 Supply process
22
22. 8.4.1 General AND 7.4.1 Supply process
23
23. 4.2 Type and extent of control AND 7.4.3 Verification of the supplied product
24
24. 8.4.3 Information for external suppliers AND 7.4.2 Information for supply
25
25. 8.4.3 Information for external suppliers AND 7.4.2 Information for supply and 7.4.3 Verification of the supplied product
26
26. 8.5.1 Control of the production and provision of the service AND 7.5.1 Control of the production and provision of the service
27
27. 8.5.1 Control of the production and provision of the service AND 7.5.1 Control of the production and provision of the service
28
28. 7.5.2 Cleanliness of the product
29
29. 7.5.1 Control of the production and provision of the service
30
30. 8.5.1 Control of the production and provision of the service AND 7.5.2 Validation of production and service provision processes
31
31. 7.5.2 Validation of production and service provision processes
32
32. 8.5.2 Identification and traceability AND 7.5.8 Identification
33
33. 8.5.2 Identification and traceability AND 7.5.9 Traceability
34
34. 8.5.3 Property belonging to external customers or suppliers AND 7.5.10 Customer ownership
35
35. 8.5.4 Preservation AND 7.5.11 Storage of the product
36
36. 8.5.5 Post-delivery activities AND 7.5.1 Control of the production and provision of the service
37
37. 7.5.3 Installation tasks
38
38. 7.5.4 Service activities
39
39. 8.5.6 Control changes AND 7.3.9 Control design and development changes
40
40. 8.6 Release of products and services AND 8.2.6 Monitoring and measurement of the product
41
41. 8.6 Release of products and services AND 7.4.3 Verification of the supplied product
42
42. 8.6 Release of products and services AND 8.2.6 Monitoring and measurement of the product
43
43. 8.7 Control of non-compliant output elements AND 8.3.1 Control of the non-compliant product - General
44
44. 8.7 Control of non-compliant output elements AND 8.3.2 Actions in response to nonconformities detected before delivery
45
45. 8.7 Control of non-compliant output elements AND 8.3.3 Actions in response to nonconformities detected after delivery
46
46. 8.7 Control of non-compliant output elements AND 8.3.4 Rework
47
Brief Knowledge Check
10 questions

Module 9 Performance evaluation

1
1. Presentation
2
2. 9.1.1 Monitoring, measurement, analysis and evaluation - General AND 8.1 Measurement, analysis and improvement - General
3
3. 9.1.1 Monitoring, measurement, analysis and evaluation - General AND 8.2.3 Monitoring and measurement of processes
4
4. 9.1.2 Customer satisfaction AND 8.2.1 Feedback
5
5. 8.2.2 Handling of complaints
6
6. 8.2.3 Reporting to regulatory authorities
7
7. 9.1.3 Analysis and evaluation AND 8.4 Data analysis
8
8. 9.1.3 Analysis and evaluation AND 8.4 Data analysis
9
9. 9.2 Internal audit AND 8.2.4 Internal audit
10
10. 9.2 Internal audit AND 8.2.4 Internal audit
11
11. 9.2 Internal audit AND 8.2.4 Internal audit
12
12. 9.3.1 Management review - General AND 5.6.1 Management review - General
13
13. 9.3.2 Input elements of the review AND 5.6.2 Input elements of the review
14
14. 9.3.3 Output elements of the review AND 5.6.3 Output elements of the review
15
Brief Knowledge Check
5 questions

Module 10 Improvement

1
1. Presentation
2
2. 10.1 General AND 8.5.1 General
3
3. 10.2 Non-compliance and corrective action AND 8.5.2 Corrective actions
4
4. 10.2 Non-conformity and corrective action AND 8.5.2 Corrective actions
5
5. Thank you for participating
6
Brief Knowledge Check
5 questions

Final Evaluation

1
Final Evaluation!
25 questions

Be the first to add a review.

Please, login to leave a review
Add to Wishlist
Get Course
Get course
One Time Payment Available in "Business Corporate Package" plan Available in "Individual Package" plan
Enrolled: 1 student
Lectures: 144

Related Courses
ISO Certification
ISO 13485:2016
€139 €119

ISO 13485:2016
OBJECTIVES: Application of quality management principles in the medical device industry Familiarizing students with the terminology used in quality...
144 Lectures
Preview this course
Add to Wishlist
€139 €119
ISO Certification
ISO 9001:2015
€149

ISO 9001:2015
GENERAL DESCRIPTION This course includes e-Learning with audio description (EN)+ 1/2 day  discussion with trainer (RO/EN) The course focuses on int...
112 Lectures
Preview this course
Add to Wishlist
€149
ISO Certification
ISO/IEC 17025:2017
€79 €69

ISO/IEC 17025:2017
GENERAL DESCRIPTION ISO 17025 accreditation demonstrates that a laboratory has an acceptable quality management system and has the ability and comp...
76 Lectures
Preview this course
Add to Wishlist
€79 €69
ISO Certification
ISO 14001:2015 Environmental Management Systems
€149

ISO 14001:2015 Environmental Management Systems
GENERAL DESCRIPTION This course includes e-Learning with audio description (EN)+ 1/2 day discussion with trainer (RO/EN)  One of the main changes b...
157 Lectures
Preview this course
Add to Wishlist
€149
ISO Certification
ISO 45001
€139 €119

ISO 45001
GENERAL DESCRIPTION Objectives of the new approach: Ensuring the effective occupational health and safety of workers and not only (e.g. visitors), ...
140 Lectures
Preview this course
Add to Wishlist
€139 €119
>

DB Academy provides top notch online courses mastering your skills partnering with reputable companies. Boost your career with Corporate trainings.

About Us Blog Privacy Policy Terms and Conditions

Popular Courses

Contact Us

  • SAYDAN Digital Solutions SRL​
  • Bucureşti Sectorul 6, Drumul CIOROGÂRLA, Nr. 297-299, Bloc 1, Scara 2, Etaj 9, Ap. 120
    Bucharest, Romania

    [email protected]
  • +40 736 190 565

© 2018 All rights reserved

Linkedin
Individual
Business
Partner

Register as Individual

For those who are individual learners, team members of a business, business professionals.

{{this.errorMessage}}

{{this.successMessage}}

By registering you accept terms and conditions

Already on DB Academy?

Register as Business

Business Leaders / HR Responsibilities / Other company representatives who want to upskill employees.

{{this.errorMessage}}

{{this.successMessage}}

By registering you accept terms and conditions

Already on DB Academy?

Register as Partner

For companies which want to colobrate with DB Academy and publish educational content for their customers.

{{this.errorMessage}}

{{this.successMessage}}

By registering you accept terms and conditions

Already on DB Academy?

Login

Authanticate to DB Academy.

{{this.errorMessage}}

{{this.successMessage}}

New to DB Academy?

Forgot your password?

Search

Category
Automotive Core Tools
Calitop
Lean Six Sigma
Communication
Communication
Compliance powered by Deloitte
Risk Management powered by Deloitte
Customer service
Essential Customer Service Skills
Digital Transformation
Agility for Digital Transformation
Collaboration tools
Data Science
Digital marketing and communication
Digital soft skills
Essential for Digital Transformation
Microsoft Office
Microsoft Office
Outlook
Power point
Security
The digital experience
Virtual work
Visio
English language
English - Level A1
English - Level A2
English - Level B1
English - Level B2
English - Level C1
English - Level C2
Executive Education
by BBS Alumni Association
Finance
Basic accounting principles
Basic principles in finance
Planning and budgeting
HR
Crisis management
Essential HR skills
HR certifications
Involvement and retention
Recruitment and employment
Leadership and Management
Delegation
Employee performance management
Generations in the field of work
Guiding change
Leadership - Essential skills
Leading your Business
Leading your Team
Leading Yourself
Management - Essential skills
Management of technical teams
Manager for the first time
Performance management
Personal development
Strategic thinking
The delegation
Become an Instructor For Enterprise