ISO 13485:2016 MDQMS Self-Assessment for Lead Auditor

The ISO 13485:2016 international standard is relevant to organizations that are involved in the life-cycle of medical devices. If you are working in such an organization, you may be selected to be involved in auditing, which is one of the most important processes in ISO 13485:2016 quality management system for medical device industry. In order to have an effective audit, we need competent auditors to plan, prepare, conduct and report on the audit.

This self-assessment test is specifically designed to serve as a tool for you to check and validate your knowledge of ISO 13485:2016, ISO 9000:2015 and ISO 19011:2018. Some users may find this test useful in preparing for the actual ISO 13485:2016 Lead Auditor Exam, as the papers are designed to include similar elements of the Lead Auditor Exam.

The composition of the test includes:

• Paper 1 – Understanding the terms, definitions and quality management principles

• Paper 2 – Understanding ISO 19011:2018 management system audit

• Paper 3 – Familiarizing with ISO 13485:2016 requirements

• Paper 4 – Identifying the nonconformities from audit scenarios

• Paper 5 – Identifying the most suitable ISO 13485:2016 requirement for nonconformity

• Paper 6 – Identifying the most suitable ISO 13485:2016 requirement for audit trail

Please note that these international standard – ISO 9000:2015, ISO 13485:2016 and ISO 19011:2018 are copyright protected documents of International Organization for Standardization (ISO). Hence, we are not permitted to share or reproduce for you. Please purchase a copy from ISO store or its authorized stores.

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