ISO 9001 Quality Management System

Evaluate ISO 9001:2015 quality management system compliance, covering leadership, planning, support, operation, performance evaluation, and continual improvement

AllManufacturingTechnologyHealthcareBiotech20 minutes19 questions

1. Context & Leadership

Have you determined internal/external issues affecting the QMS?*

Clause 4.1: Understand organizational context and factors

Are interested parties and their requirements identified?*

Clause 4.2: Stakeholders (customers, regulators, suppliers)

Does top management demonstrate leadership and commitment to QMS?*

Clause 5.1: Accountability, policy, objectives, resources

Is a quality policy established and communicated?*

Clause 5.2: Policy appropriate to purpose, framework for objectives

2. Planning & Risk

Are risks and opportunities addressed in QMS planning?*

Clause 6.1: Risk-based thinking integral to QMS

Are quality objectives established and plans to achieve them?*

Clause 6.2: SMART objectives with action plans

Are changes to QMS planned and controlled?*

Clause 6.3: Change management for QMS modifications

3. Support & Resources

Are adequate resources provided for QMS effectiveness?*

Clause 7.1: People, infrastructure, environment, monitoring resources

Are personnel competent based on education, training, experience?*

Clause 7.2: Competence requirements, training, evaluation

Is documented information controlled and maintained?*

Clause 7.5: Document control, records management

4. Operational Planning & Control

Are processes planned, implemented, and controlled?*

Clause 8.1: Operational planning meets product/service requirements

Are customer requirements determined and reviewed?*

Clause 8.2: Ensure ability to meet customer and regulatory requirements

Are design and development activities controlled?*

Clause 8.3: Design planning, inputs, outputs, controls, verification, validation

Are externally provided processes/products controlled?*

Clause 8.4: Supplier/subcontractor evaluation and monitoring

5. Performance Evaluation

Do you monitor, measure, analyze, and evaluate QMS performance?*

Clause 9.1: Determine what, how, when to monitor/measure

Are internal audits conducted at planned intervals?*

Clause 9.2: Audit program to verify QMS conformity and effectiveness

Does top management review QMS at planned intervals?*

Clause 9.3: Management review evaluates suitability, adequacy, effectiveness

6. Improvement

Are nonconformities corrected and corrective actions taken?*

Clause 10.2: React to nonconformity, eliminate root cause, prevent recurrence

Is the QMS continually improved?*

Clause 10.3: Improve processes, products, services (PDCA cycle)

Please answer all required questions to see your results