Audit 9001 - Checklist

☐ Conforming ☐ Conforming with minor nonconformities ☐ Nonconforming (major nonconformities)

Clause 4 – Context of the Organization | Ref | Question | Evidence / Y/N / Notes | |-----|----------|------------------------| | 4.1 | Has the organization determined external and internal issues relevant to its purpose and strategic direction? | List of issues (SWOT, PESTLE) | | 4.2 | Have relevant interested parties (customers, suppliers, regulators) been identified, along with their requirements? | Stakeholder matrix, requirement records | | 4.3 | Is the scope of the QMS defined, documented, and justified for any exclusions (e.g., design if not applicable)? | Scope statement, exclusion justification | | 4.4 | Are processes, their interactions, inputs, outputs, criteria, methods, resources, risks, and opportunities documented and managed? | Process map, turtle diagrams, procedure list | Clause 5 – Leadership | Ref | Question | Evidence | |-----|----------|----------| | 5.1 | Does top management demonstrate leadership and commitment to the QMS? | Policy deployment, resource allocation, meeting minutes | | 5.1b | Is the quality policy communicated, understood, and applied? | Policy on wall, employee interviews | | 5.2 | Is the quality policy appropriate, available, and reviewed for continuing suitability? | Policy document, review records | | 5.3 | Are roles, responsibilities, and authorities for QMS assigned and communicated? | Org charts, job descriptions, appointment letters | Clause 6 – Planning | Ref | Question | Evidence | |-----|----------|----------| | 6.1 | Has the organization determined risks and opportunities that affect QMS conformity? | Risk register, action plans | | 6.2 | Are quality objectives defined for relevant functions/levels, monitored, and communicated? | Objectives KPI sheet, monitoring results | | 6.3 | Are plans in place to achieve objectives (resources, responsibility, timeframes)? | Action plans, project plans | | 6.3 | Have changes to the QMS been planned and managed systematically? | Change control log, communication of changes | Clause 7 – Support | Ref | Question | Evidence | |-----|----------|----------| | 7.1 | Are adequate resources (people, infrastructure, environment, monitoring equipment) available? | Equipment list, facility conditions, hiring records | | 7.1.5 | Is monitoring and measuring equipment calibrated/traceable? | Calibration register, stickers, certificates | | 7.2 | Are personnel competent based on education, training, or experience? | Competence matrix, training records, interview | | 7.3 | Do employees have awareness of quality policy, objectives, and their contribution? | Random employee interviews | | 7.4 | Is internal and external communication regarding QMS effective? | Communication logs, meeting minutes, intranet | | 7.5 | Is documented information controlled (review, approval, version, access)? | Document control list, revision history, access restrictions | | 7.5.3 | Are records retained and protected from loss/damage? | Retention schedule, backup logs, filing system | Clause 8 – Operation | Ref | Question | Evidence | |-----|----------|----------| | 8.1 | Is operational planning and control implemented to meet product/service requirements? | Production plans, work instructions | | 8.2 | Are customer requirements reviewed before commitment (orders, contracts, tenders)? | Order review records, amendment logs | | 8.3 | If design applies: Is design & development planning, inputs, controls, outputs, and changes managed? | Design plan, review minutes, verification records | | 8.4 | Are external providers evaluated, monitored, and controlled based on their ability to supply? | Supplier approval list, performance scorecard, re-evaluation | | 8.4.2 | Are requirements for external providers clearly communicated? | Purchase orders, contracts, specifications | | 8.5 | Are production and service provision carried out under controlled conditions (e.g., work instructions, monitoring)? | Shop floor conditions, process controls | | 8.5.2 | Is traceability maintained where required? | Traceability records, batch/lot numbers | | 8.5.3 | Is customer or external provider property identified, verified, and protected? | Property log, damage reporting process | | 8.5.4 | Are preservation measures (handling, storage, packaging) in place? | Warehouse inspection, packaging standards | | 8.5.5 | Are post-delivery activities (warranty, maintenance, returns) defined and performed? | Service records, customer support logs | | 8.6 | Is product/service release only after verification of requirements? | Inspection reports, sign-offs, test certificates | | 8.7 | Are nonconforming outputs identified, controlled, and dispositioned (rework, scrap, concession)? | Nonconformance report, disposition log, rework records | Clause 9 – Performance Evaluation | Ref | Question | Evidence | |-----|----------|----------| | 9.1 | Is QMS performance monitored, measured, analyzed, and evaluated? | KPI dashboards, trend analysis | | 9.1.2 | Is customer satisfaction monitored (surveys, complaints, feedback)? | Survey results, complaint logs, feedback analysis | | 9.2 | Are internal audits conducted at planned intervals; are auditors objective and competent? | Audit schedule, audit reports, auditor training records | | 9.3 | Is management review conducted at planned intervals, addressing QMS suitability, adequacy, effectiveness? | Management review minutes, action items | Clause 10 – Improvement | Ref | Question | Evidence | |-----|----------|----------| | 10.1 | Has the organization identified and acted on opportunities for improvement? | Improvement log, Kaizen records | | 10.2 | Are nonconformities addressed with corrective actions to prevent recurrence? | CAPA form, root cause analysis, effectiveness check | | 10.2 | Are corrective actions appropriate to the effects of the nonconformity? | Risk-based evaluation of nonconformities | | 10.3 | Is continual improvement embedded in QMS processes? | Improvement projects, trend of KPIs upward | Audit Summary Sheet | Section | Conforming? (Y/N/Partial) | Major Nonconformities | Minor Nonconformities | Observations / OFIs | |---------|----------------------------|-----------------------|-----------------------|----------------------| | 4 – Context | | | | | | 5 – Leadership | | | | | | 6 – Planning | | | | | | 7 – Support | | | | | | 8 – Operation | | | | | | 9 – Evaluation | | | | | | 10 – Improvement | | | | | audit 9001 checklist