ISO 9001:2015 Audit Checklist for QMS Compliance

100 Items

Comprehensive ISO 9001:2015 audit checklist covering all QMS clauses, documentation, and processes to ensure compliance and continual improvement.

ISO 9001 Quality Management Audit Guide

This ISO 9001 Quality Management Audit Guide provides a detailed checklist to evaluate your organization’s compliance with ISO 9001:2015 standards. It covers all key clauses including context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. This structured tool helps internal auditors verify documentation, assess process effectiveness, identify nonconformities, and ensure continual improvement across all departments for certification readiness.

1. Context of the Organization

1Has the organization identified external and internal issues relevant to its purpose and strategic direction?

2Does it monitor and review those issues on a regular basis?

3Have interested parties (stakeholders) relevant to the QMS been determined?

4Are the requirements of those interested parties identified and kept up to date?

5Is the scope of the QMS documented and justified (i.e., boundaries, exclusions)?

6Are QMS processes and their interactions defined, documented, and maintained?

7Are criteria and methods for process operation and control established?

8Are risks and opportunities (relative to context and interested parties) assessed and addressed?

9Is there evidence that changes in context trigger a review of QMS scope or processes?

10Has the organization ensured that the QMS can achieve intended outcomes within the defined context?

2. Leadership

1Does top management demonstrate leadership and commitment to the QMS?

2Is the quality policy established, communicated, and aligned with strategic direction?

3Are quality objectives set and consistent with the policy?

4Are roles, responsibilities, and authorities within the QMS assigned and communicated?

5Does top management promote risk-based thinking and support other management roles?

6Are accountability and authority for nonconformity resolution clearly vested?

7Is there evidence that leadership ensures that customer focus is promoted?

8Has top management ensured integration of the QMS into business processes?

9Are resources and support actively provided by leadership?

10Are management review outputs acted upon (i.e., decisions, improvement, resource changes)?

3. Planning

1Has the organization determined risks and opportunities to address to ensure QMS achieves intended results?

2Are planned actions for those risks/opportunities integrated into business processes?

3Are quality objectives planned, measurable, and consistent with policy?

4Is there a plan showing how objectives are achieved (who, what, when, resources)?

5When changes to the QMS are needed, is planning of the change systematic and controlled?

6Are the effects (impacts) of changes considered before implementation?

7Do planned changes maintain or improve conformity of products/services?

8Are changes approved before implementation and communicated appropriately?

9Are potential unintended consequences of changes assessed?

10Are risks associated with changes monitored and mitigated?

4. Support

1Are resources (people, infrastructure, environment) adequate for QMS implementation and maintenance?

2Are competence requirements determined, and is evidence of training, skills, or experience maintained?

3Are employees aware of the quality policy, objectives, their roles, and consequences of nonconformities?

4Are there effective internal/external communication processes (what, when, with whom, how)?

5Is documented information required by ISO 9001 and by the organization maintained and controlled?

6Are controls in place for document approval, review, update, revision, retention, and disposal?

7Are records protected against loss, damage, deterioration, or unauthorized access?

8Are measurement traceability, calibration, and maintenance of measuring devices ensured?

9Is organizational knowledge maintained and updated to support the QMS and improvement?

10Are resource constraints identified in advance and mitigated (e.g., manpower, equipment)?

5. Operation

1Are the requirements for products and services determined, documented, and reviewed (customer, statutory, regulatory)?

2Are changes in requirements communicated and controlled?

3If design and development apply: are design inputs, interfaces, outputs, reviews, verification, validation, changes controlled?

4Are external provider (supplier) controls established, evaluated, monitored, and re-evaluated?

5Are criteria for acceptance of purchased products/services defined and records maintained?

6Are processes for production or service provision controlled (i.e., process parameters, resource control, work instructions)?

7Is there a process for handling nonconforming outputs, deviations, rework, and corrective actions?

8Are final product/service release criteria defined and met (inspections, tests)?

9Are product identification and traceability maintained throughout production and delivery?

10Are changes to operational processes controlled and documented (e.g., modifications, process steps)?

6. Performance Evaluation

1Has the organization determined what to monitor, measure, analyze, and evaluate (processes, products, customer satisfaction)?

2Are suitable methods used to ensure valid measurement results?

3Is monitoring and measuring equipment calibrated or verified?

4Are results of monitoring, measurement, and analysis evaluated against objectives and requirements?

5Is customer feedback (complaints, satisfaction, returns) collected and analyzed?

6Is internal audit conducted at planned intervals, covering all relevant functions and processes?

7Are internal audit findings reported, and is follow-up action taken?

8Does top management conduct periodic management reviews with structured inputs and outputs?

9Are key performance indicators (KPIs) monitored and trending over time?

10Is data from performance evaluation used to drive improvement, corrective action, or risk mitigation?

7. Improvement

1Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS?

2Are nonconformities identified, documented, and corrective actions taken to eliminate root causes?

3Are corrective actions evaluated for effectiveness and verified?

4Are opportunities for improvement identified (from audits, reviews, analyses) and acted upon?

5Is process performance or product conformity improvement documented and tracked?

6Is innovation or proactive change (preventive mindset) part of improvement initiatives?

7Are lessons learned shared across functions and processes?

8Are changes made as a result of improvement communicated and controlled?

9Is the impact of corrective and improvement actions assessed (positive/negative)?

10Is management review fed with information on improvement actions, nonconformities, and results?

8. Documented Information & Records Control

1Are all mandatory ISO 9001 documents (procedures, policies, work instructions) present and current?

2Is there a document control procedure for creation, review, approval, change, and versioning?

3Are records (audit, training, calibration, inspections) defined, identifiable, stored, and retrievable?

4Are retention times for records defined and enforced?

5Are obsolete or superseded documents removed from use or clearly marked?

6Are records protected against damage, loss, unauthorized access, or deterioration?

7Are backup and archival arrangements in place (digital and physical)?

8Is access to documented information controlled by roles and permissions?

9Are changes to documented information reviewed, approved, and re-communicated?

10Are external documents (standards, regulatory documents) included and controlled if used?

9. Internal Audit & Management Review

1Is an internal audit program planned, maintained, and updated (scope, frequency, criteria)?

2Are auditors independent from the areas they audit?

3Are audit plans approved and communicated in advance?

4During audits, do auditors follow documented checklists, collect objective evidence, and report findings?

5Are nonconformities raised formally with clear descriptions, severity, and reference to evidence?

6Are corrective actions assigned, tracked, and closed out with verification?

7Is there follow-up to confirm that corrective actions were effective?

8Are audit results compiled and reviewed for trends or recurring issues?

9Is management review conducted at planned intervals, with required inputs (audit results, customer feedback, performance data)?

10Are outputs of management review (decisions, changes, resource allocation, improvements) documented and followed up?

10. Customer Focus & Customer Satisfaction

1Are customer requirements (expressed, implied, legal) collected, documented, and reviewed?

2Is there a process for resolving customer complaints, feedback, or returns?

3Are trends in customer satisfaction or dissatisfaction monitored and analyzed?

4Is corrective action on customer complaints timely and effective?

5Is customer communication tracked (order changes, status, feedback)?

6Are delivery, quality, and service performance metrics measured against customer expectations?

7Are customer-specific quality requirements (contracts, specifications) formally incorporated into processes?

8Is there a process for identifying potential new customer needs and opportunities for improvement?

9Are last-minute changes or special requests from customers handled and documented properly?

10Are lessons from customer feedback or dissatisfaction fed into the QMS improvement loop?

Overall Progress

Total Progress0/100

0% complete

Checklist Progress

1. Context of the Organization0/10

2. Leadership0/10

3. Planning0/10

4. Support0/10

5. Operation0/10

6. Performance Evaluation0/10

7. Improvement0/10

8. Documented Information & Records Control0/10

9. Internal Audit & Management Review0/10

10. Customer Focus & Customer Satisfaction0/10

Checklist Progress0 of 100 items completed

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