Backup 5/12/2022





  Overview of ISO 13485

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (MDQMS)

Published by International Organization for Standardization (ISO) for the first time in 1996, ISO 13485 contains a comprehensive quality management system for the design and manufacture of medical devices.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Who Should Use ISO 13485?
 

1. Any organisation that are involved in one or more stages of the life-cycle in the medical devices and related services, including:

1. design and development,
2. production,
3. storage and distribution,
4. installation, or
5. servicing of a medical device and design and development or provision of associated activities (e.g. technical support); and
6. suppliers or external parties that provide product, including quality management system related services to you. 

2. Any organization that wants to establish, implement, operate, and maintain an MDQMS. 

3. You may face the risks and lost opportunities involved with not having an ISO 13485:

• where ISO 13485 may be a legal or contractual requirement; and
• you will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to organisations that have ISO 13485.

Requirements of ISO 13485:2016

Clause 4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Medical device file
4.2.4 Control of documents
4.2.5 Control of records

Clause 5 Management responsibility
5.1 Management commitment
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

Clause 6 Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control

Clause 7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
7.2.3 Communication
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Servicing activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Particular requirements for validation of processes for sterilization and
sterile barrier systems
7.5.8 Identification
7.5.9 Traceability
7.5.10 Customer property
7.5.11 Preservation of product
7.6 Control of monitoring and measuring equipment

Clause 8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
8.2.3 Reporting to regulatory authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement of processes
8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to nonconforming product detected before delivery
8.3.3 Actions in response to nonconforming product detected after delivery
8.3.4 Rework
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
 
MLOK’s methodology and approach to making your company ISO 13485 complied for certification

We adopt four stages of the most practical and methodological process to help you certified for ISO 13485.

Stage 1: Planning

Conduct Kick-Off Meeting to:

1. establish implementation schedule and plan;
2. appoint MDQMS Committee;
3. establish a documentation framework; and
4. have a fundamental understanding of the requirements of ISO 13485.

Stage 2: Documentation

Drafting and writing documents  to comply with ISO 13485 requirements:

1. MDQMS Manual;
2. Job Description;
3. MDQMS Procedures;
4. MDQMS Supporting Process Procedures;
5. MDQMS System Procedures; and
6. MDQMS Forms, Work Instructions and others.

Stage 3: Implementation

1. Guidance and advice on the implementation of the documented MDQMS.
2. To conduct an ISO 13485 MDQMS Internal Audit Training.
3. To conduct an ISO 13485 MDQMS Internal Audit.
4. To conduct an ISO 13485 MDQMS Management Review Meeting.

Stage 4: External Audit

        • Stage 1 Documentation Audit by the Certification Body.
        • Rectification of Stage 1 Audit Finding issued by the Certification Body.
        • Stage 2 Audit Compliance Audit by the Certification Body.
        • Rectification of Stage 2 NCRs issued by the Certification Body.

You will then receive your ISO 13485 certificate.