TS EN ISO 13485 Training and Scope

• What is 13485?
• Quality Management System Benefits for Medical Devices
• Quality Management Principles and Process Model
• Compatibility with Other Systems
• Risk management
• Reinforcing the 13485 requirements with examples in the production of medical devices,
• Establishing a link between legal requirements and standard requirements
• Having general information about the establishment of ISO 13485 Quality System
• Questions, evaluation of education
• Issuing a certificate
• CE Marking
• New approach directives
• Definitions
• Harmonized standards
• Steps to follow to hit the CE mark
• technical file detail
• Declaration of conformity
• Questions, evaluation of education
• Issuing a certificate

TS EN ISO IEC / 17021 (former TS EN 45012) Training and Scope

• Definitions
• principles

1. Impartiality
2. sufficiency
3. Responsibility
4. Openness
5. security
6. Resolution of complaints

• General conditions

1. Legal and contractual considerations
2. Managing impartiality
3. Liability and financing

• Structural conditions

1. Organizational structure and top management
2. neutrality protection committee

• Welding conditions

1. Competence of management and staff
2. Personnel involved in certification activities
3. Use of outsourced individual auditors and technical experts
4. Personnel records
5. Outsourcing

• Information terms

1. public information
2. Certification documents
3. Documented customers register
4. Reference to documentation and use of marks
5. security
6. Exchange of information between the certification body and its customers

• Process conditions

1. General conditions
2. Initial audit and certification
3. surveillance activities
4. Recertification
5. Certification of special audits
6. Suspension, withdrawal or reduction of certification Appeals
7. Complaints
8. Records of applicants and clients

• Management system requirements for certification bodies

1. Options
2. Management system requirements according to ISO 9001 standard
3. General management system requirements