Preparing an ISO 9001 audit
From programme to plan to work documents
Preparation converts the audit programme into a feasible audit. First, initiate: confirm audit objectives, scope (processes, sites, shifts, boundaries), criteria (ISO 9001 plus the organization's own QMS documentation, contracts, statutory requirements), and feasibility - time, access, information, cooperation. Then review relevant documented information: scope, policy, objectives, process maps, previous findings, complaints, KPIs, changes, and prior audit results. Documentation review informs the plan; it does not by itself produce nonconformities.
The audit plan allocates time and personnel to processes according to importance, risk and previous performance - not equally across clauses. It names auditees and their functions, dates, sampling approach, and expected outputs. Work documents normally include the plan, checklists or process worksheets, sampling plans, forms for findings, and meeting agendas.
Rules of thumb:
- Plan by process and by risk, not clause-by-clause.
- Use audit trails - follow one product or order from requirement to delivery - to sample many clauses at once.
- Never make a checklist a script: it prompts questions, it does not fix them.
- Reserve 10–15% of time for the unexpected.
Traps: planning to 'cover all of clause 8' in an hour; writing a plan that omits top management (clause 5 cannot be evidenced from the shop floor); deciding a finding during document review; failing to confirm access, guides, safety or shift patterns before arriving.