4. Systemic Requirements

4.1  Organizational requirements

4.1.1  Establish a QMS.

4.1.2  Clarify structure.

4.1.3  Support processes.

4.1.4  Manage changes.

4.1.5  Control outsourcing.

4.1.6  Validate software.

4.2  Documentation requirements

4.2.1  Manage information.

4.2.2  Prepare manual.

4.2.3  Establish files.

4.2.4  Control documents.

4.2.5  Maintain records.

5. Management Requirements

5.1  Commitment requirements

5.2  External requirements

5.3  Policy requirements

5.4  Planning requirements

5.4.1  Establish quality objectives.

5.4.2  Carry out quality planning.

5.5  Managerial requirements

5.5.1  Clarify responsibility and authority.

5.5.2  Appoint management representative.

5.5.3  Establish internal communications.

5.6  Review requirements

5.6.1  Perform regular management reviews.

5.6.2  Examine management review inputs.

5.6.3  Generate management review outputs.

6. Resource Requirements

6.1  Allocation requirements

6.2  Personnel requirements

6.3  Infrastructure requirements

6.4  Environmental requirements

6.4.1  Control your working conditions.

6.4.2  Plan your contamination controls.

7. Realization Requirements

7.1  Planning requirements

7.2  Customer requirements

7.2.1  Determine product requirements.

7.2.2  Review your product requirements.

7.2.3  Communicate product requirements.

7.3  Development requirements

7.3.1  Prepare design and development procedures.

7.3.2  Organize design and development activities.

7.3.3  Determine design and development inputs.

7.3.4  Generate design and development outputs.

7.3.5  Carry out design and development reviews.

7.3.6  Perform design and development verifications.

7.3.7  Conduct design and development validations.

7.3.8  Manage design and development transfers.

7.3.9  Control design and development changes.

7.3.10 Maintain design and development files.

7.4  Purchasing requirements

7.4.1  Establish purchasing process.

7.4.2  Clarify purchasing information.

7.4.3  Verify purchased products.

7.5  Production requirements

7.5.1  Control medical device production and service provision.

7.5.2  Define requirements for cleanliness or contamination controls.

7.5.3  Specify product installation and verification requirements.

7.5.4  Develop servicing procedures and reference materials.

7.5.5  Maintain a record of sterilization process parameters.

7.5.6  Validate processes used for production and service provision.

7.5.7  Validate processes for sterilization and sterile barrier systems.

7.5.8  Preserve product identity throughout product realization.

7.5.9  Establish suitable traceability procedures and records.

7.5.9.1  Establish suitable product traceability procedures.

7.5.9.2  Establish suitable records for implantable devices.

7.5.10  Protect property supplied for medical devices by customers.

7.5.11  Preserve medical device products and components.

7.6  Measurement requirements.

8. Remedial Requirements

8.1  Planning requirements

8.2  Research requirements

8.2.1  Implement suitable feedback methods and procedures.

8.2.2  Develop and document complaint handling procedures.

8.2.3  Establish and maintain regulatory reporting procedures.

8.2.4  Plan and perform internal audits at planned intervals.

8.2.5  Find out whether processes achieve planned results.

8.2.6  Monitor and measure medical device characteristics.

8.3  Product requirements

8.3.1  Prevent unintended delivery or use of nonconforming products.

8.3.2  Control nonconforming products detected prior to delivery.

8.3.3  Manage nonconforming products detected after delivery.

8.3.4  Specify how product rework should be carried out.

8.4  Analytical requirements

8.5  Improvement requirements

8.5.1  Take action to change QMS and products.

8.5.2  Take action to correct actual nonconformities.

8.5.2  Take action to prevent potential nonconformities.

Introduction to ISO 13485 2016

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Checklist

ISO 13485 2016 Quality Management Gap Analysis