Compare ISO 14001 and ISO 13485
ISO 13485 is a Quality Management Standard which is used for the design and manufacture of medical devices.
ISO 14001 is an Environmental Management System (EMS) which provides a structure for measuring and improving an organization’s environmental impact.
When you compare ISO 14001 and ISO 13485, they share these elements:
- Policy
- Monitoring and Measurement
- Responsibility and Authority
- Corrective and Preventive Action
- Communication
- Records
- Competence, training and awareness
- Document control
- Audits
- Management review
The main difference between ISO 13485 and ISO 14001 is that:
- ISO 13485 requires more attention to the regulatory requirements and it only asks for the QMS to be implemented and maintained.
- ISO 14001 focuses on managing your organization's impact on the external environment, to reduce pollution and comply with regulations
ISO 13485 differs from 14001 in several areas critical to the Medical Device industry:
- Since ISO 13485 is for the medical devices industry, the rules are stringent with respect to the design and manufacture of medical devices and the control of their changes as against maintaining a Environmental Management System (EMS) and its hazards maintenance.
- Focus on meeting regulatory requirements versus reducing pollution and carbon foot print.
- Additional documentation requirements (depending on product) including
- Regulatory requirements
- Health, cleanliness, sterilization
- Risk management
- Purchased material for traceability
- Labeling and packaging
Helpful Information
ISO 13485
- Helpful information:
Download the ISO 13485-ISO 14001 Comparison Table
| ISO 13485 Clause | ISO 14001:2004 Clause |
|---|---|
| 1. SCOPE | 1. SCOPE |
| 1.1 General | |
| 1.2 Application | |
| 2. Normative references | 2. Normative References |
| ISO 9000:2005 | |
| 3. Terms and definitions | 3. Terms and definitions |
| 3.1 Active Implantable Medical Device | |
| 3.2 Active Medical Device | |
| 3.3 Advisory Notice | |
| 3.4 Customer Complaint | |
| 3.5 Implantable Medical Device | |
| 3.6 Labeling | |
| 3.7 Medical Device | |
| 3.8 Sterile Medical Device | |
| 4 Quality Management System | 4. Environmental Management System Requirements |
| 4.1 General Requirements | 4.1 General Requirements |
| 4.2 Documentation Requirements | 4.4.4 Documentation |
| 4.2.1 General | |
| 4.2.2 Quality Manual | |
| 4.2.3 Control of Documents | 4.4.5 Control of Documents |
| 4.2.4 Control of Records | 4.5.4 Control of Records |
| 5 Management Responsibility | |
| 5.1 Management Commitment | |
| 5.2 Customer Focus | 4.3.1 Environmental Aspects and Hazards |
| 5.3 Quality Policy | 4.2 Environmental Policy |
| 5.4 Planning | 4.3 Planning |
| 5.5 Responsibility, authority and communication | |
| 5.5.1 Responsibility and Authority | 4.4.1 Resources, Roles, Responsibility and Authority |
| 5.5.2 Management Representative | 4.4.1 Resources, Roles, Responsibility and Authority |
| 5.5.3 Internal Communication | 4.4.3 Communication |
| 5.6 Management Review | 4.6 Management Review |
| 5.6.1 General | |
| 5.6.2 Review Input | 4.6 Management Review |
| 5.6.3 Review Output | 4.6 Management Review |
| 6 Resource Management | |
| 6.1 Provision of Resources | 4.4.1 Resources, Roles, Responsibility and Authority |
| 6.2 Human Resources | |
| 6.2.1 General | 4.4.2 Competence, Training and Awareness |
| 6.2.2 Competence, Training and Awareness | 4.4.2 Competence, Training and Awareness |
| 6.3 Infrastructure | 4.4.1 Resources, Roles, Responsibility and Authority |
| 6.4 Work Environment | |
| 7 Product Realization | 4.4 Implementation and Operation |
| 7.1 Planning of Product Realization (ISO 14971) | 4.4.6 Operational Control |
| 7.2 Customer-related Processes | |
| 7.2.1 Determination of requirements related to the product | 4.3.2 Legal and other requirements |
| 7.2.2 Review of requirements related to the product | 4.3.1 Environmental Aspects and Hazards |
| 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 | |
| 7.3.4 Design and Development Review | |
| 7.3.5 Design and Development Verification | |
| 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 | |
| 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 Product & Service provision | |
| 7.5.1.2.1 Cleanliness of Product & Contamination Control | |
| 7.5.1.2.2 Installation Activities | |
| 7.5.1.2.3 Servicing Activities | |
| 7.5.1.3 Sterile Medical Device Requirements | |
| 7.5.2 Validation of Processes for Production and Service Provision | |
| 7.5.2.1 General Requirements | |
| 7.5.2.2 Sterile Medical Device Requirements | |
| 7.5.3 Identification and Traceability | |
| 7.5.3.1 Identification | |
| 7.5.3.2 Traceability | |
| 7.5.3.2.1 General (Consider Configuration Management) | |
| 7.5.3.2.2 Implantable Medical Device Requirements | |
| 7.5.3.3 Status Identification | |
| 7.5.4 Customer Property (Can Include IP) | |
| 7.5.5 Preservation of Product | |
| 7.6 Control of Monitoring and Measuring Equipment (USE ISO 10012) | |
| 8 Measurement, Analysis and Improvement | 4.5 Checking |
| 8.1 General | |
| 8.2 Monitoring and Measurement | |
| 8.2.1 Feedback | |
| 8.2.2 Internal Audit (See ISO 19011) | 4.5.5 Internal Audit |
| 8.2.3 Monitoring and Measurement of Processes | 4.5.2 Evaluation of Compliance |
| 8.2.4 Monitoring and Measurement of Product | 4.5.1 Monitoring and Measurement |
| 8.2.4.1 General Requirements | |
| 8.2.4.2 Implantable Medical Device Requirements | |
| 8.3 Control of Nonconforming Product | 4.5.2.3 Nonconformity, Corrective and Preventive Action |
| 8.4 Analysis of Data | |
| 8.5 Improvement | |
| 8.5.1. General | |
| 8.5.2 Corrective Action | |
| 8.5.3 Preventive Action |