A clause-by-clause self-assessment for small and medium manufacturers preparing for the ISO 9001:2026 revision. Score each item, total your gaps, and you have the skeleton of a closure plan before a consultant ever walks in the door.
Company: ______________________ Assessed by: ______________________ Date: ____________ Current certification status: ☐ Not certified ☐ 9001:2015 certified ☐ Transitioning to 2026
Scoring:0 = Nothing in place | 1 = Informal / undocumented | 2 = Documented but not consistently followed | 3 = Documented, followed, and evidenced. Anything scored 0–2 is a gap; anything scored 0–1 belongs on your priority closure plan.
Clause 4 — Context of the Organization
Item
Score (0–3)
Notes / Evidence
Internal and external issues affecting the QMS are identified and reviewed (including technology shifts such as AI adoption)
__
Interested parties and their requirements are documented
__
QMS scope is documented, including justification for any exclusions
__
Processes, their sequence, and interactions are mapped with owners assigned
__
Clause 5 — Leadership
Item
Score (0–3)
Notes / Evidence
Top management can demonstrate accountability for QMS effectiveness (not delegated wholesale to a quality manager)
__
Quality policy is documented, communicated, and understood on the floor
__
Roles, responsibilities, and authorities are assigned and communicated
__
Customer requirements and applicable regulatory requirements are determined and met consistently
__
Clause 6 — Planning
Item
Score (0–3)
Notes / Evidence
Risks and opportunities are identified with actions planned (risk-based thinking is evidenced, not just claimed)
__
Quality objectives are measurable, resourced, and tracked
__
Changes to the QMS are planned and controlled (including introduction of new software or AI tools into quality-critical processes)
__
Clause 7 — Support
Item
Score (0–3)
Notes / Evidence
Resources, infrastructure, and work environment are determined and maintained
__
Measurement equipment is calibrated / verified with records retained
__
Competence requirements are defined; training records are current
__
Organizational knowledge is captured (not locked in one veteran's head)
__
Documented information is controlled: creation, revision, approval, and retention
__
Clause 8 — Operation
Item
Score (0–3)
Notes / Evidence
Operational planning and control criteria are established for production processes
__
Customer requirements are reviewed before commitment (quotes, orders, changes)
__
Design and development is controlled (if applicable)
__
Suppliers are evaluated, selected, and monitored with criteria and records
__
Production is carried out under controlled conditions (work instructions, process monitoring, identification & traceability)
__
Nonconforming outputs are identified, contained, and dispositioned with records
__
Clause 9 — Performance Evaluation
Item
Score (0–3)
Notes / Evidence
Monitoring and measurement of processes and products is defined and performed
__
Customer satisfaction is monitored and acted on
__
Internal audits are planned, performed by impartial auditors, and reported
__
Management reviews are held with required inputs and recorded outputs / decisions
__
Clause 10 — Improvement
Item
Score (0–3)
Notes / Evidence
Nonconformities trigger corrective action with root-cause analysis (CAPA)
__
Effectiveness of corrective actions is verified, not just closed
__
Continual improvement is evidenced (trends, projects, before/after results)