Iso 13485 Quality Checklist Mdqms

For organizations providing medical devices and related services, ISO 13485:2016 specifies requirements for a quality management system enabling them to consistently meet customer and applicable regulatory requirements. Use this self-assessment checklist for internal audits to determine if your organization’s QMS is aligned with the ISO 13485:2016 standard and evaluate your readiness for a third-party ISO 13485:2016 certification audit. ​

ISO 13485 Quality Checklist (MDQMS)



Management Controls

1. Quality Manual defines scope of QMS, procedures (or reference to) within QMS, and description of the interaction of processes within QMS? (ISO 13485:2016: 4.1, 4.2.2)


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2. Criteria and methods are in place to monitor and control processes for effectiveness? (ISO 13485:2016: 4.1.3(a), 4.2.1(d), 8.4)


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3. Firm has established and conducts Management Reviews, at least annually? (ISO 13485:2016: 5.1(d), 5.6)


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4. Management reviews examine suitability and effectiveness of quality systems, improvements needed because of customer requirements, and resource needs? (ISO 13485:2016: 4.1.3(c), 5.6.1, 5.6.3, 6.1, 8.4)


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5. Management review addresses audit results, customer feedback, process performance, Corrective and Preventive Actions (CAPAs), previous management reviews, changes to QMS, recommendations for improvement, and new or revised regulatory requirements? (ISO 13485:2016: 5.6.2)


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6. Firm has established a Quality Manual and Quality System Procedures and Instructions that are appropriate? (ISO 13485:2016: 4.1.2(a), 4.2.1(b), (c)


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7. Firm has established Quality Plan? (ISO 13485:2016: 4.2.1(d), 5.4)


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8. Quality Planning addresses QMS needs and Quality Objectives? (ISO 13485:2016: 5.4.2)


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9. Firm has implemented Quality Policy and Quality Objectives? (ISO 13485:2016: 4.2.1(a), 5.1(b), (c), 5.3, 5.4.1)


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10. Firm has established Quality Audit procedures and conducts audits? (ISO 13485:2016: 4.2, 8.2.4)


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11. Quality audits examine compliance and effectiveness? (ISO 13485:2016: 4.1.3(c), 4.2.1(d), 8.2.4)


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12. Auditors are trained? (ISO 13485:2016: 6.2, 8.2.4)


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13. Audits are conducted by objective parties? (ISO 13485:2016: 8.2.4)


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14. Quality audits are linked to CAPA? (ISO 13485:2016: 8.2.4)


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15. Review organizational structure of firm. Resources are available to support processes? (ISO 13485:2016: 4.1.3(b), 5.1(e), 5.5.1, 5.5.2, 6.1, 6.2)


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16. Firm has defined a management representative with executive responsibility for implementing and reporting quality management system? (ISO 13485:2016: 5.1, 5.5.1, 5.5.2, 6.1, 6.2)


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17. Appropriate responsibilities, authority, and resources are in place for quality system activities? (ISO 13485:2016: 5.1(e), 5.5.1, 5.5.2, 6.1, 6.2)


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18. Firm has established procedures for identifying training needs and personnel are trained to perform assigned responsibilities? (ISO 13485:2016: 6.2)


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19. Executive management ensures adequate and effective quality system is implemented? Ensure management is committed to and communicates importance of meeting customer requirements, regulatory requirements, and QMS. (ISO 13485:2016: 5.1(a), 5.2, 5.5.3)


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Design And Development / Design Controls

1. Products are subject to design controls? (ISO 13485:2016: 7.1, 7.3)


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2. Design control and risk management procedures are established and applied? (ISO 13485:2016: 7.3)


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3. Design and development stages are identified? (ISO 13485:2016: 7.3.2)


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4. Review, verification, validation, and design transfer activities at each stage are appropriate? (ISO 13485:2016: 7.3.2)


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5. Responsibilities for design and development are defined? (ISO 13485:2016: 7.3.2)


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6. Review the project design & development plan, responsibilities, and interfaces. Design & development plan is updated, reviewed, and approved? (ISO 13485:2016: 7.3.2)


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7. Design input requirements were established, reviewed, and approved? (ISO 13485:2016: 7.2.1, 7.3.3)


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8. Customer requirements are captured? (ISO 13485:2016: 7.2.1, 7.3.3)


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9. Inputs include functional, performance, safety, and statutory and regulatory requirements? (ISO 13485:2016: 7.2.1, 7.3.3)


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10. Incomplete, ambiguous, and/or conflicting requirements were addressed? (ISO 13485:2016: 7.3.3)


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11. Design & development outputs are established, verifiable, reviewed, and approved? (ISO 13485:2016: 7.3.4(a), (c))


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12. Design & development outputs are appropriate for purchasing, production, and servicing? (ISO 13485:2016: 7.3.4(b))