ISO 9001 Audit Application
Quality Management

Risk-based approach (clause 6.1), strengthened leadership, removal of the mandatory management representative, documented information instead of procedures/records, risk-based thinking integrated into every process.

3-year cycle: initial audit (stage 1 document review + stage 2 on-site audit), then annual surveillance audits (years 2 and 3), then renewal audit. The accredited certification body must itself be accredited by an IAF member.

Incomplete management review (clause 9.3), lack of documented risk and opportunity analysis (6.1), non-measurable quality objectives (6.2), insufficient control of outsourced processes (8.4), and poor traceability of corrective actions (10.2).

Define the audit scope and criteria, assemble a team of auditors independent of the process being audited, prepare an audit plan with clauses to cover, collect objective audit evidence (documents, records, observations, interviews), write the report with classified findings (major/minor/observation).

Major non-conformity: complete absence of a process required by the standard, or systemic failure that calls into question the effectiveness of the QMS. Minor non-conformity: isolated or partial deviation that does not call the system as a whole into question. An accumulation of minors on the same process can be reclassified as a major.