Clause 4.1
Determine external and internal issues relevant to the purpose and strategic direction of the organization.
Documentation
Objective evidence
Gap
No gap identified
Accountable
Marisol Vega
Executive
Clause 5.3
Assign and communicate responsibilities and authorities for relevant roles within the QMS.
Documentation
Objective evidence
Gap
No gap identified
Accountable
Priya Raman
Human Resources
Clause 6.1
Plan actions to address risks and opportunities and evaluate the effectiveness of those actions.
Documentation
Objective evidence
Gap
Effectiveness review for 4 of 19 mitigations has not been recorded.
Record effectiveness review for open mitigations R-07, R-11, R-14, R-18.
Accountable
Marisol Vega
Quality
Clause 7.2
Determine necessary competence, ensure competence on the basis of education, training or experience, and retain documented information as evidence.
Documentation
Objective evidence
None
Gap
No competency assessments exist for 24 warehouse operators.
Run warehouse competency assessment cycle and upload signed records.
Accountable
Priya Raman
Human Resources
Clause 8.4
Ensure externally provided processes, products and services conform to requirements; apply criteria for evaluation and re-evaluation of suppliers.
Documentation
None
Objective evidence
Gap
Supplier evaluation criteria described in interviews but not documented; no re-evaluation records for 2026.
Generate Supplier Evaluation Procedure and 2026 re-evaluation records.
Accountable
Tobias Lang
Procurement
Clause 8.5.1
Implement production under controlled conditions, including availability of documented information and monitoring activities.
Documentation
Objective evidence
Gap
No gap identified
Accountable
Grace Oyelaran
Operations
Clause 9.2
Conduct internal audits at planned intervals and retain documented information as evidence of implementation.
Documentation
Objective evidence
Gap
3 of 6 planned internal audits for 2026 are not yet executed.
Schedule internal audits for Operations, HR and Maintenance.
Accountable
Ahmed Bello
Quality
Clause 10.2
React to nonconformities, evaluate the need for action to eliminate causes, and retain evidence of results.
Documentation
None
Objective evidence
None
Gap
No corrective action process operating outside of production scrap reports.
Draft Corrective Action Procedure and CAR form, assign owner.
Accountable
Unassigned
Quality