Template

Internal Audit: Design and Development ISO 9001 13485

by Pete Newbould, from the Community

20+

This internal audit checklist helps assess design and development activities against ISO 9001 and ISO 13485 requirements. Use it to verify inputs and outputs, design planning, risk management, design reviews, verification and validation, design transfer, documentation, and change control. Capture objective evidence, assign actions, and track nonconformities to strengthen your quality management system and maintain regulatory compliance for manufacturing and medical device contexts.

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With SafetyCulture you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

About author

Community

This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
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Comprehensive audit checklist covering ISO 9001 and ISO 13485 requirements. Includes quality policy, documentation control, calibration, and complaint management procedures.
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Downloads: 200+
Get
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ISO 13485 Audit Checklist for QMS Compliance
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by Rohan Pawar, from the Community
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ISO 9001 Audit Checklist
Use this ISO 9001 audit checklist to evaluate your quality management system against ISO 9001 requirements. Review documentation and records, management commitment, customer focus, quality policy and planning, roles and communication, and management review inputs and outputs. Assess resource management, human resources and training, infrastructure, and work environment. Audit product realization including requirements, design and development, purchasing, production and service provision, and monitoring and measurement. Record nonconformities, data analysis, and continual improvement actions including corrective and preventive actions.
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ISO 9001:2015 Process Audit Checklist
Use this ISO 9001:2015 process audit checklist to evaluate your quality management system against key clauses, including planning, operational control, customer communication, design and development, and supplier management. Capture evidence, record findings and nonconformities, and track actions to improve process performance and compliance. Ideal for internal audits and continual improvement.
by Quality CTL SEAL, from the Community
Downloads: 200+
Get

ISO 9001 and ISO 13485 Quality Management System Audit Guide

Comprehensive audit checklist covering ISO 9001 and ISO 13485 requirements. Includes quality policy, documentation control, calibration, and complaint management procedures.

by Pete Newbould, from the Community

200+

Get

Template

ISO 13485 Audit Checklist for QMS Compliance

Use this ISO 13485 audit checklist to evaluate whether your quality management system aligns with ISO 13485:2016 for medical devices. The checklist covers management controls, design and development, risk management, CAPA, medical device reporting, production and process controls, supplier and purchasing controls, sterilization validation, documentation and records, customer requirements, and technical files. Ideal for quality managers preparing for third party certification audits and ongoing compliance.

by Rohan Pawar, from the Community

10+

Get

Template

ISO 9001 Audit Checklist

Use this ISO 9001 audit checklist to evaluate your quality management system against ISO 9001 requirements. Review documentation and records, management commitment, customer focus, quality policy and planning, roles and communication, and management review inputs and outputs. Assess resource management, human resources and training, infrastructure, and work environment. Audit product realization including requirements, design and development, purchasing, production and service provision, and monitoring and measurement. Record nonconformities, data analysis, and continual improvement actions including corrective and preventive actions.

by Bill Henry, from the Community

100+

Get

Template

ISO 9001:2015 Process Audit Checklist

Use this ISO 9001:2015 process audit checklist to evaluate your quality management system against key clauses, including planning, operational control, customer communication, design and development, and supplier management. Capture evidence, record findings and nonconformities, and track actions to improve process performance and compliance. Ideal for internal audits and continual improvement.

by Quality CTL SEAL, from the Community

200+

Get

Internal Audit: Design and Development ISO 9001 13485

About author

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ISO 9001 and ISO 13485 Quality Management System Audit Guide

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