ISO 9001:2015 audit preparation checklist
By PMCEPC (NEEV INTERNATIONAL) · Updated
A practical checklist for ISO 9001:2015 audits: clause structure, documented information, internal audits, management review and how to handle nonconformities.
Know the structure
ISO 9001:2015 is organised in clauses 4 to 10: context of the organisation, leadership, planning, support, operation, performance evaluation and improvement. Auditors test each of these against your processes and records, so a simple map from clauses to your procedures helps everyone.
Context, scope and risk
Document the scope of your quality management system, interested parties and their requirements, and the risks and opportunities you have identified. Show how these fed into objectives and planning.
Documented information
Keep the records the standard requires and the ones you need to control your processes. Check that documents are current, approved and available where work is done, and that records can be retrieved quickly.
Operations and customer focus
Be ready to show how you review customer requirements, plan and control production or service delivery, control suppliers, release products and handle nonconforming outputs. Auditors often follow one order from enquiry to delivery.
Internal audit and management review
Run an internal audit across all processes before the external audit, close the findings, and hold a management review that covers the required inputs and records decisions and actions. Gaps here are among the most common findings.
Handling nonconformities
A major nonconformity usually means a requirement is not met or the system fails to achieve its intent, while a minor one is an isolated lapse. For each finding, correct the issue, find the root cause and verify that the action worked.
Certification cycle
Certification is granted by an accredited certification body after a staged initial audit, then maintained through surveillance audits and a recertification audit before the certificate expires.
Frequently asked questions
Can PMCEPC certify my company?
No. Certificates are issued by accredited certification bodies. PMCEPC can perform an independent readiness or internal audit to help you prepare.
How long does preparation take?
It depends on how mature your system is. Organisations with working processes may need weeks, while those starting from scratch usually need several months.
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