ISO 13485:2016 Quick Reference

ISO 13485:2016 Clauses Requirement Key Words

4. Quality Management System
4.1 General Requirements (title only)
4.1.1 (untitled) Documented QMS; documented roles of organization
4.1.2 (untitled) Processes; sequence; interaction; risk based approach
4.1.3 (untitled) Process approach; records as evidence
4.1.4 (untitled) Process changes; impact on QMS and medical devices
4.1.5 (untitled) Outsourcing; responsibility retained; written agreements
4.1.6 (untitled) Procedure for software application validation; records
4.2 Documentation Requirements (title only)
4.2.1 General Documented policy, objectives, and quality manual
4.2.2 Quality Manual QMS scope; process interaction; documentation outline
4.2.3 Medical Device File Device/ family files; conformity/compliance evidence; DMR
4.2.4 Control of Documents Procedure; changes; availability; protection; retention
4.2.5 Control of Records Procedure; storage; security; retention; disposal

5. Management Responsibility
5.1 Management Commitment Evidence of top management commitment to QMS
5.2 Customer Focus Customer requirements; applicable regulations
5.3 Quality Policy Commitment; framework; understood; reviewed
5.4 Planning (title only)
5.4.1 Quality Objectives Relevant functions and levels; measurable
5.4.2 Quality Management System Planning Planning of QMS; maintain integrity when changes
5.5 Responsibility, Authority, and Communication (title only)
5.5.1 Responsibility and Authority Documented; communicated; interrelation; independence
5.5.2 Management Representative Appointed; member of management; QMS effectiveness
5.5.3 Internal Communications Processes for communication regarding QMS effectiveness
5.6 Management Review (title only)
5.6.1 General Procedure; QMS reviews; planned intervals; records
5.6.2 Review Input Feedback; complaints; audits; measures; actions; changes
5.6.3 Review Output Decisions; actions; improvements; changes; resource needs

6. Resource Management
6.1 Provision of Resources Resources; QMS implementation; effectiveness; requirements
6.2 Human Resources Procedure; competency; training; actions; awareness; records
6.3 Infrastructure Facilities; equipment; support services; maintenance records
6.4 Work Environment and Contamination Control (title only)
6.4.1 Work Environment Procedure; health; cleanliness; clothing; special conditions
6.4.2 Contamination Control Documented controls; work environment; personnel; product

7. Product Realization
7.1 Planning of Product Realization Process planning; documented risk management; records;
7.2 Customer-Related Processes (title only)
7.2.1 Determination of Requirements Related to the Product Customer; regulatory; user training; organization
7.2.2 Review of Requirements Related to the Product Documented; Reviewed prior to commitment; records
7.2.3 Customer Communication Customers; regulators; products; complaints; advisory notices
7.3 Design and Development (title only)
7.3.1 General Documented procedures
7.3.2 Design and Development Planning Documented stages; reviews; V&V; responsibilities; resources
7.3.3 Design and Development Inputs Functions; performance; usability; safety; regulations; risks
7.3.4 Design and Development Outputs Criteria; safe and proper use; suitable form; records
7.3.5 Design and Development Review Documented arrangements; evaluation; actions; records
7.3.6 Design and Development Verification Documented verification plans; outputs meet inputs; records
7.3.7 Design and Development Validation Documented validation plans; representative product; records
7.3.8 Design and Development Transfer Procedure; transfer to manufacturing; verification; records
7.3.9 Control of Design and Development Changes Procedure; evaluation of changes; actions; records
7.3.10 Design and Development Files File for medical device or family; records of evidence; DHF

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 ISO 13485:2016 Quick Reference
ISO 13485:2016 Clauses Requirement Key Words
7. Product Realization
7.4 Purchasing (title only)
7.4.1 Purchasing Process Procedure; evaluation; selection; re-evaluation; records
7.4.2 Purchasing Information Product description; agreement to notify of changes; records
7.4.3 Verification of Purchased Product Inspection; proportionate to risks; supplier premises; records
7.5 Production and Service Provision (title only)
7.5.1 Control of Production and Service Provision Procedures; monitoring; controls; traceability records; DHR
7.5.2 Cleanliness of Product (was 7.5.1.2.1) Documented cleanliness requirements; contamination controls
7.5.3 Installation Activities (was 7.5.1.2.2) Documented installation requirements; criteria for verification
7.5.4 Servicing Activities (was 7.5.1.2.3) Procedures; analysis of servicing records; complaints
7.5.5 Particular Requirements for Sterile Medical Devices Records of sterilization process parameters; batch traceability
7.5.6 Validation of Processes for Production and Service Provision Procedure; process validation; SW validation; records
7.5.7 Particular Requirements for Validation of Processes for Procedure; validation for implementation and change; records
Sterilization and Sterile Barrier Systems
7.5.8 Identification Procedure; product status; unique device identification
7.5.9 Traceability (title only)
7.5.9.1 General Procedure; regulatory requirements; traceability records
7.5.9.2 Particular Requirements for Implantable Medical Devices Supplier records; shipping package consignee records
7.5.10 Customer Property Protection; safeguarding; reporting of any unsuitable property
7.5.11 Preservation of Product Procedure; processing; storage; handling; distribution; records
7.6 Control of Monitoring and Measuring Equipment Procedure; calibration; software validation procedure; records

8. Measurement, Analysis, and Improvement

8.1 General Planning; monitoring; measurement; analysis; improvement
8.2 Monitoring and Measurement (title only)
8.2.1 Feedback Procedure; measure of effectiveness; input to risks
8.2.2 Complaint Handling Procedure; investigation; reporting; actions; records
8.2.3 Reporting to Regulatory Authorities Procedure; adverse events; advisory notices; records
8.2.4 Internal Audit Procedure; criteria; scope; interval; methods; actions; records
8.2.5 Monitoring and Measurement of Processes Monitoring methods; process measurements; actions
8.2.6 Monitoring and Measurement of Product Procedure; evidence of conformity; personnel identification
8.3 Control of Nonconforming Product (title only)
8.3.1 General Procedure; nonconformity controls; decisions; records
8.3.2 Actions in Response to Nonconforming Product Detected Dealing with NC product; concessions; justification; records
Before Delivery
8.3.3 Actions in Response to Nonconforming Product Detected After Procedure; advisory notices; actions based on effects; records
Delivery
8.3.4 Rework Procedure; potential adverse effect; verification; records
8.4 Analysis of Data Procedure; collection; analysis; statistical techniques; records
8.5 Improvement (title only)
8.5.1 General Changes; QMS effectiveness; medical device safety
8.5.2 Corrective Action Procedure; reviews; causes; actions; verification; records
8.5.3 Preventive Action Procedure; reviews; causes; actions; verification; records

Changes to clause numbering and clause titles are in Italics and underlined.
Deleted terms in titles are shown with a strikethrough.

See Annex A for Comparison of Content between ISO 13495:2003 and ISO 13485:2016.
See Annex B for Correspondence between ISO 13485:2016 and ISO 9001:2015.

Contact Whittington & Associates, LLC at 770-862-1766 or at <Larry@WhittingtonAssociates.com>.

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