ISO 9001 LA study plan
ISO 9001 LA · Give each week a clear focus.
8 weeks · About 8 hours per week
Fundamental principles and concepts of a quality management system & Quality management system (QMS) requirements
Map the seven quality management principles to concrete behaviours an auditor would look for in an organisation
Diagram the process approach and the PDCA cycle as they apply to clauses 4 through 10
Define, in your own words, the terms: quality policy, objective, risk, opportunity, process, procedure, nonconformity, corrective action
Walk the clause 4 and clause 5 requirements (context, interested parties, scope, leadership, policy, roles) and list at least three auditable evidence sources for each
Your checkpoint
A one-page concept map linking the seven principles, PDCA, and clauses 4-10, plus a personal glossary of 20 defined terms
Quality management system (QMS) requirements
Break down clause 6 (risks and opportunities, quality objectives, change planning) and identify what an auditor must see as evidence
Trace clause 7 (resources, competence, awareness, communication, documented information) into interview questions
Outline clause 8 (operational planning, design, external providers, production, release, nonconforming outputs) at the level of intent, not procedure detail
Distinguish 'documented information required to be maintained' from 'required to be retained' across the standard
Your checkpoint
A clause-by-clause evidence table covering clauses 6, 7 and 8 with at least two objective evidence examples per sub-clause
Quality management system (QMS) requirements & Fundamental audit concepts and principles
Complete clause 9 and 10 (monitoring, internal audit, management review, improvement, nonconformity and corrective action) and state what a mature versus immature system looks like
Explain the seven audit principles in ISO 19011 and give a behavioural example of each
Differentiate first-party, second-party and third-party audits, and certification versus accreditation
Identify the roles and responsibilities of client, auditee, audit team and lead auditor
Your checkpoint
A written comparison of a conforming versus a weak clause 9.2/9.3 implementation (500 words) plus a completed principles-to-behaviour table
Preparing an ISO 9001 audit
Draft audit objectives, scope and criteria for a realistic hypothetical organisation
Apply a risk-based approach to allocate audit time and effort across clauses and processes
Build a document review checklist that targets the required documented information without turning into a clause checklist
Compose an audit plan and an opening-meeting agenda consistent with ISO 19011 guidance
Write sampling-justified interview questions for at least four processes
Your checkpoint
A complete audit preparation pack: objectives, scope, criteria, risk-based audit plan, document review checklist and interview question set
Conducting an ISO 9001 audit
Sequence an audit from opening meeting to evidence collection and describe the purpose of each step
Practise evidence-gathering techniques: interviewing, observation, sampling and tracing a process end to end
Apply the audit trail technique to follow a single requirement across several processes
Distinguish audit evidence from opinion and record where each of your conclusions came from
Your checkpoint
A process-tracing worksheet for one end-to-end process showing at least 12 evidence entries linked to specific clauses
Conducting an ISO 9001 audit
Classify findings as conforming, observation, minor nonconformity, major nonconformity or opportunity for improvement using stated criteria
Write nonconformity statements containing requirement, objective evidence and the gap, without prescribing the fix
Evaluate corrective action submissions for root cause adequacy and evidence of effectiveness
Reach an audit conclusion and justify it against the audit objectives
Handle disagreement and pushback from an auditee during a finding discussion
Your checkpoint
Ten practice nonconformity reports written to a strict format, each cross-checked against a written grading rubric with a self-score
Closing an ISO 9001 audit
Prepare and run a closing meeting agenda that covers findings, conclusions, and next steps
Structure an audit report covering scope, criteria, findings, conclusions and any limitations
Define the follow-up process, timelines and criteria for closing out corrective actions
Explain how surveillance, recertification and special audits differ in purpose and content
Your checkpoint
A full mock audit report of 4-6 pages with executive summary, findings register and follow-up schedule, reviewed against a criteria checklist
Managing an ISO 9001 audit program & Conducting an ISO 9001 audit
Design a risk-based audit programme covering a multi-site organisation across a three-year cycle
Establish programme performance indicators and a competence evaluation method for auditors
Integrate all seven domains by completing a timed full-length practice examination
Analyse every missed practice question back to its domain and clause before re-testing
Your checkpoint
A written three-year audit programme plan plus a timed practice exam score of at least 80% with a documented review of all errors
Milestones
Week 2: Can explain clauses 4-8 from memory and cite at least two evidence sources per clause without notes
Week 4: Audit preparation pack reviewed against ISO 19011 plan requirements; all five elements present and self-assessed as complete
Week 6: Eight of ten practice nonconformity statements score at least 80% on the written rubric, with correct clause citation and no prescriptive wording
Week 8: Timed practice exam at 80% or above, plus a complete three-year audit programme plan