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ISO 13485 (QMS - Medical Devices) : Workshops-Training-Certification


ISO 13485 QMS Standards - is a Quality management standard used globally for medical devices. It is used to establish and update your organization's Quality Management System (QMS). ISO is a process standard for medical devices, it generally help organizations achieve standards of process quality that are recognized and respected throughout the world.


1. Scope

1.1. General

1.2. Application

2. Normative references

3. Terms and definitions

4. Quality management system

4.1. General requirements

4.2. Documentation requirements

4.2.1. General

4.2.2. Quality manual

4.2.3. Control of documents

4.2.4. Control of records

5. Management Responsibility

5.1. Management commitment requirements

5.2. Customer focus

5.3. Quality Policy

5.4. Planning

5.4.1. Quality Objectives

5.4.2. Quality Management system planning

5.5. Responsibility, Authority and communication

5.5.1. Responsibility and authority

5.5.2. Management Representative

5.5.3. Internal Communication

5.6. Management Review

5.6.1. General

5.6.2. Review Input

5.6.3. Review Output

6. Resource Management

6.1. Provision of Resources

6.2. Human Resources Requirements

6.2.1. General

6.2.2. Competence, awareness and training

6.3. Infrastructures requirements

6.4. Work Environment requirements

7. Product Realization

7.1. Planning of Product Realization

7.2. Customer Related Processes Requirements

7.2.1. Determination of Requirements related to the Product

7.2.2. Review of requirements related to the product requirements

7.2.3. Customer Communication

7.3. Design and Development

7.3.1. Design and Development Planning

7.3.2. Design and Development Inputs

7.3.3. Design and Development Outputs requirements

7.3.4. Design and Development Review

7.3.5. Verification requirements

7.3.6. Design and development validation

7.3.7. Control of Design and Development Changes

7.4. Purchasing

7.4.1. Purchasing process

7.4.2. Purchasing Information

7.4.3. Verification of purchased product requirements

7.5. Production and service provision

7.5.1. Control of production and service provision

7.5.1.1. General requirements

7.5.1.2. Control of production and service provision - Specific requirements

7.5.1.2.1. Cleanliness of product and contamination control

7.5.1.2.2. Installation activities

7.5.1.2.3. Servicing activities

7.5.1.3. Particular requirements for sterile medical devices

7.5.2. Validation of processes for production and service provision

7.5.2.1. General requirements

7.5.2.2. Particular requirements for sterile medical devices

7.5.3. Identification and traceability

7.5.3.1. Identification

7.5.3.2. Traceability

7.5.3.2.1. Traceability - General

7.5.3.2.2. Particular requirements for active implantable medical devices and implementable medical devices

7.5.3.3. Status identification

7.5.4. Customer property requirements

7.5.5. Preservation of product

7.6. Control of Monitoring and Measuring Devices requirements

8. Measurement, analysis and improvement

8.1. Measurement, analysis and improvement general requirements

8.2. Monitoring and measurement

8.2.1. Feedback

8.2.2. Internal Audit requirements

8.2.3. Monitoring and Measurement of Processes

8.2.4. Monitoring and Measurement of Product requirement

8.2.4.1. Monitoring and measurement of product – general requirements

8.2.4.2. Particular requirement for active implantable devices and implantable devices

8.3. Control of Nonconforming Product

8.4. Analysis of Data requirements

8.5. Improvement

8.5.1. General

8.5.2. Corrective Action

8.5.3. Preventive Action

Some of the requirements in ISO 13485 Standards include a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement for medical devices.


Following benefits are as follows :
  • Determine the needs and expectations of customers
  • Determine the capability of process for customers, as per basic processes for ISO 13485 standard
  • Establish policies, objectives and a work environment
  • Necessary to motivate people to satisfy these needs
  • Design, implement and manage a system of inter-related processes to implement the policy and attain the objectives
  • Measure and analyze the effectiveness of each process in fulfilling its objectives, and
  • Pursue the continual improvement of the system from an objective evaluation of its performance

Interested Participants or Audiences ?

VQMS specifically designed course, meets the requirements of the following:
  • Fresh or exp engineering graduates / MBA’s / Professionals / Job seekers.
  • leader of projects in HR/Admin/ Management team of Organizations
  • Managers or Future managers including management students
  • Quality Assurance Engineers, Team leaders, IT or Non-IT Professionals, Practitioners, Software Quality Assurance team members and Jr /Senior Management
  • Any other professional members who are doing research, innovations or consulting in process improvement practices


Mode of Payment :
  • VQMS Flexible Payment modes are Cash or Others (any)
  • Other payment modes are Demand Draft / Cheque / Credit and Debit Cards.
  • DD/Cheque to be made in the favour of “Vigorous Quality Management System”, payable at New Delhi.

Post Completion of the course :
  • VQMS assist in resume preparation
  • Assisting in improving interview skills vis-a-vis six sigma & Quality (Business excellence)
  • Provide exclusive counselling in other areas of improvement.