Skip to content
v0.1.3latest release121 skills4 categories6 sub-categories247 tested scripts397 reference docsContact us

Grading Gaps and Planning Closure

Reference for iso-9001-gap-analyzer · 44 lines

Manufacturing & Industrial Operations / Quality Management & ISO 9001v1.0.0Updated OCT 25 20262 references3 scripts

Grades used by certification bodies

GradeDefinition (ISO/IEC 17021-1 terms)Typical exampleEffect on certification
Major nonconformityAffects the capability of the QMS to achieve intended results: a requirement not addressed at all, or a systemic breakdownNo internal audits done; no management review; nonconforming product shipped routinelyCertification cannot be recommended until corrected and verified (often a follow-up visit)
Minor nonconformityA single lapse that does not affect the system's capabilityOne overdue calibration; one training record missingCorrective action plan accepted; verified at the next audit
Opportunity for improvementNo requirement broken; a risk or weaknessKPI trend not analysedOptional

gap_score.py grades not-met core clauses as major because their absence is exactly what auditors call a systemic breakdown. Treat the grade as a forecast, not a certainty: the auditor decides on the evidence seen.

Readiness thresholds

ScoreNo majorsMeaning
>= 90%yesBook stage 1. Remaining minors can close before stage 2
75-90%yes1-3 months of focused work; confirm records exist for 3 months
< 75% or any major-Build the system first; certification date is not credible yet

Records need time: most bodies want to see the QMS operating for about 3 months, with at least one full internal audit cycle and one management review, before stage 2.

Turning gaps into a closure plan

  1. Order by dependency, not clause number. Context (4.1, 4.2) -> scope (4.3) -> processes (4.4) -> policy and objectives (5.2, 6.2) -> risks (6.1) -> operational controls (8) -> monitoring (9.1) -> audit (9.2) -> management review (9.3). An audit cannot run before the processes it audits exist.
  2. One owner and one date per gap. Owners are process owners, not the quality manager by default.
  3. Define the evidence of closure in the same row: "risk register QF-06 approved, reviewed at MR 2026-12".
  4. Re-score monthly with the same worksheet; report the readiness trend to top management.
GapOwnerActionEvidence of closureDue
6.1 not metOps directorBuild risk/opportunity register from 4.1/4.2 issues, assign actionsQF-06 approved, actions in progress2026-12-15
9.2 not metQMTrain 2 internal auditors, audit all processes onceAudit programme + 6 reports2027-02-28

Interviewing during a gap assessment

  • Ask people to show, not tell: "show me the last NCR you raised", "show me where this drawing revision is controlled".
  • Sample across shifts and roles; one good answer from the quality manager is not evidence for the shop floor.
  • Record the exact evidence (document number, record date, person's role) so a "met" can be defended.
More in Quality Management & ISO 9001

8d-problem-solving-report-writer

Write and review 8D problem-solving reports for customer complaints and serious nonconformities (automotive and aerospace practice: Ford Global 8D, VDA, GM, Stellantis formats): D0 emergency response, D1 cross-functional team and champion, D2 problem description with 5W2H and is / is-not and no cause in the statement, D3 interim containment within 24 hours with verification and clean point, D4 verified occurrence and escape (non-detection) root causes plus systemic cause, D5 permanent corrective actions for each cause verified before implementation, D6 implementation, validation with production data and removal of containment, D7 PFMEA, control plan and read-across to similar products, D8 closure and recognition. Checks an 8D discipline by discipline for missing content, human-error root causes, missing escape cause or action, late containment and dates out of order.

acceptance-sampling-plan-selector

Select and evaluate acceptance sampling plans for incoming, in-process and final inspection: ANSI/ASQ Z1.4 / ISO 2859-1 single sampling under normal inspection (code letter from lot size and inspection level I, II, III, S-1 to S-4; sample size, Ac and Re from AQL, following the table's arrows to the correct plan; 100% when n reaches the lot size; AQLs above 10 per 100 units), operating characteristic curves (Pa at any quality, producer's quality level, indifference point, LTPD, AOQ and AOQL, binomial or hypergeometric), plans designed from producer and consumer risk, and c = 0 zero-acceptance plans. Covers AQL choice by defect class, switching rules between normal, tightened and reduced inspection, when sampling is not appropriate, and random sampling.

approved-supplier-list-manager

Manage and audit an approved supplier list (ASL) / external provider register for ISO 9001 8.4.1, IATF 16949 8.4 and AS9100 8.4.1: supplier status (approved, conditional, probation, pending, disqualified), scope of approval by commodity and process, risk class, certification and expiry, re-evaluation intervals by risk, conditions with end dates, single-source contingency, approver and customer-directed sources. Audits the list for expired or expiring certificates, overdue re-evaluations, conditional or probation status past its decision date, high-risk suppliers without the required certification, single-source suppliers without backup and missing approvers, and checks purchase orders for suppliers that are off-list, disqualified or pending, or buying outside the approved scope. Covers ERP blocks, PO requirements, off-list and emergency purchases.

apqp-phase-planner

Plan and track Advanced Product Quality Planning (AIAG APQP 3rd edition, IATF 16949) for a new or changed automotive part: back-schedule the five phases (plan and define, product design, process design, product and process validation, launch and feedback) from the start-of-production date by program complexity, with overlap, PPAP lead and safe-launch period; list the deliverables and gate for each phase (DFMEA, DVP&R, feasibility, process flow, PFMEA, control plans, MSA, Ppk, run at rate, PPAP, safe launch, lessons learned); adjust for build-to-print suppliers; flag compressed timelines and late or untracked deliverables against a status list. Covers gate reviews, red/yellow/green status reporting, run at rate and safe-launch exit criteria.

as9100-gap-analyzer

Run an AS9100D / EN 9100:2018 gap analysis for aviation, space and defence suppliers on the requirements added to ISO 9001: on-time delivery and conformity focus, management representative, ethics and human-factors awareness, operational planning and operational risk management, configuration management, product safety, counterfeit-part prevention, special requirements, critical items and key characteristics, external provider register and flow-down, FOD prevention, tooling and NC program control, special process validation, first article inspection (AS9102), traceability, in-service data and nonconforming product control. Generates and scores a worksheet, grades missing core controls as major, and checks invalid n/a claims. Covers AS9101/AS9104, OASIS, AS9102 FAI forms, counterfeit standards (AS5553, AS6174, AS6081), NADCAP and the planned IA9100 transition.

audit-report-writer

Write internal, supplier and pre-certification audit reports with the content ISO 19011:2018 6.5 expects: audit objectives, scope, criteria with revisions, dates, team and auditees, method and sampling statement, specific strengths, findings table and three-part finding details (requirement, evidence, statement), conclusion on the degree of fulfilment of criteria, diverging opinions, follow-up deadlines and distribution. Builds a Markdown report from a JSON audit record, generates the conclusion from the findings (major / minor / none) and flags reports missing required content or findings without clause or evidence. Covers conclusion wording, closing meetings, response expectations and verifying corrective actions.