ISO 9001 LI study plan

Explain the seven quality management principles and give one concrete QMS practice that operationalises each principle in a real organisation.

Draw the PDCA cycle and map each ISO 9001:2015 clause group (4 to 10) onto the correct PDCA phase, stating one requirement per clause group.

Distinguish the process approach from a procedure-based approach, and identify process inputs, outputs, sequence, interaction, criteria and performance indicators for a chosen process.

Describe risk-based thinking and locate where the standard requires it, specifically clauses 4.1, 5.1.2, 6.1, 8.1, 9.1.3 and 10.2.

Classify documented information as mandatory under the standard versus organisation-determined, quoting the clause that requires each mandatory item.

Conduct a context analysis using PESTLE and SWOT and convert the outputs into external and internal issues relevant to the QMS.

Identify interested parties, their relevant requirements and which of those the organisation adopts, and record the monitoring method for each.

Determine and justify the QMS scope, including any exclusion with a written justification that does not compromise conformity of products or services.

Build an implementation business case covering sponsor, budget, governance, timeline and expected benefits, and define the implementation team RACI.

Define the QMS implementation project structure: steering committee, process owners, working groups and reporting cadence.

Derive risks and opportunities directly from the week-2 context and interested-party registers, and address each with a planned action.

Write five measurable quality objectives using SMART criteria, each with a baseline, target, deadline, owner, monitoring method and reporting frequency.

Plan changes to the QMS in line with clause 6.3, stating purpose, consequences, resource needs, responsibility and authority.

Determine the resources, competence, infrastructure and environment needed to execute the implementation plan, and set the acceptance criteria for each.

Sequence the implementation activities so that documented information, process controls and measurement are built in a logical dependency order.

Draft a quality policy that is appropriate to purpose and context, provides a framework for setting objectives, and commits to applicable requirements and continual improvement.

Assign QMS roles, responsibilities and authorities so that every clause requiring an assigned responsibility has a named owner.

Build a competence matrix for all roles affecting quality and identify gaps with a training and evaluation plan.

Design an internal and external communication plan covering what, when, with whom and how for QMS-relevant information.

Establish documented information control rules for creation, approval, distribution, version control, retention and disposal.

Translate each operational clause (8.1 to 8.7) into a written control description covering criteria, resources, records and monitoring.

Design an external provider evaluation, selection, monitoring and re-evaluation process, including the criteria applied.

Define design and development controls, or document justified non-applicability, including review, verification, validation and change control.

Specify release and acceptance controls, including who authorises release, what evidence is retained and how traceability is maintained.

Establish a nonconforming output process covering identification, segregation, correction, rework, concession and notification to customers where relevant.

Define monitoring, measurement, analysis and evaluation methods for each quality objective, including data source, frequency and evaluation criteria.

Establish calibration and measurement traceability controls under clause 7.1.5, including what to do when measuring equipment is found unfit for purpose.

Write a risk-based internal audit programme for a full 12-month cycle covering all clauses, shifts, sites and processes.

Conduct a mock internal audit of two processes using a checklist, record at least three findings with objective evidence, and classify each against the standard.

Prepare a management review agenda and inputs covering every clause 9.3.2 element, and define the outputs expected under 9.3.3.

Process a nonconformity end to end: contain, determine root cause with 5-Whys and Ishikawa, implement correction and corrective action, and verify effectiveness.

Build a continual improvement register with at least five improvement opportunities, each with an owner, baseline metric and expected benefit.

Explain the certification audit process flow: application, contract, stage 1 readiness review, stage 2 conformity assessment, certification decision, surveillance and recertification.

Distinguish major and minor nonconformities, and describe the corrective action submission and verification timelines a certification body typically applies.

Complete a clause-by-clause gap analysis of a sample organisation scoring each clause on a 0-3 maturity scale.

Run a mock stage 1 audit to confirm documentation adequacy, scope, process identification and readiness for stage 2.

Run a mock stage 2 audit covering at least six clauses, answering auditor questions in role and recording the evidence you would present.

Close every open gap from week 7 and update the evidence register so that no major gap remains.

Complete three timed 60-question practice papers and analyse wrong answers by domain to target the weakest two domains.

Rehearse the audit-day logistics: document pack, interview schedule, escort roles, opening meeting roles and nonconformity response protocol.