AI Checklist Generator

Email address

Home > create a check list for an aduit from iso 13485 clause 6.2

create a check list for an aduit from iso 13485 clause 6.2

Review the ISO 13485 standard and understand clause 6.2 requirements.

Identify audit team members and assign responsibilities.

Schedule the audit date and communicate with relevant stakeholders.

Prepare the audit plan, including scope and objectives.

Gather relevant documentation, including quality manuals and procedures.

Verify the existence of documented procedures for training and competence.

Check records of training and qualifications for personnel.

Review job descriptions for key positions related to product realization.

Assess the effectiveness of training programs in relation to quality objectives.

Observe training sessions and methods used to assess competence.

Evaluate the onboarding process for new employees.

Review continuous education and training initiatives for existing staff.

Assess the adequacy of resources provided for training purposes.

Collect feedback from employees regarding training effectiveness.

Analyze performance data to correlate training with quality outcomes.

Identify any gaps in knowledge or skills that may impact product quality.

Review corrective actions taken regarding previous training-related nonconformities.

Document findings and observations during the audit.

Prepare an audit report summarizing strengths and weaknesses.

Discuss findings with management and relevant personnel.

Develop an action plan for addressing any identified issues.

Schedule follow-up audits to ensure corrective actions are implemented.

Encourage feedback on the audit process from the audit team and auditees.

Discuss lessons learned and potential improvements for future audits.

Update training and competency procedures based on audit findings.

Ensure ongoing compliance with ISO 13485 standards through regular reviews.

Hey there! Here's a little about us or visit our recurring workflow SaaS: Manifestly Checklists

Light Dark