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iso-9001-quality-manual-writer

Write or modernise an ISO 9001:2015 quality manual that describes the company's own QMS: scope with products, services and sites, justified requirements not applicable (only 7.1.5, 8.3, 8.5.3, 8.5.5), process map and interaction table with owners, inputs, outputs, KPIs and documents, quality policy, roles and authorities, pointers to procedures and registers, and a clause cross-reference. Generates a Markdown manual draft from a JSON company profile and reviews an existing manual for missing scope, unjustified or invalid exclusions, missing policy or process interaction, ISO 9001:2008 leftovers (management representative, preventive action, six mandatory procedures), text that parrots 'the organization shall', placeholders and the 2024 climate-change amendment. Use when a company needs a quality manual, is updating a 2008-style manual, or an auditor criticised the manual.

Manufacturing & Industrial Operations / Quality Management & ISO 9001v1.0.0Updated OCT 25 20262 references2 scripts

A quality manual is optional under ISO 9001:2015, but the scope it contains is mandatory and the process map is what auditors ask for first. A good manual is short (8-15 pages), true to how the company works, and points to the procedures and registers that hold the detail. scripts/manual_scaffold.py drafts one from a company profile; scripts/manual_check.py reviews an existing manual.

Trigger Conditions

Activate this skill when the user:

  • Needs a quality manual for a new ISO 9001 system
  • Has a 2008-era manual (management representative, preventive action, six procedures) to modernise
  • Received an audit finding about scope, exclusions or process interaction
  • Asks "do we need a quality manual?", "what goes in a quality manual?", "can we exclude design?"

Policy wording: quality-policy-objectives-drafter; procedures the manual points to: qms-procedure-writer.

Workflow

text
1. COLLECT   -> company, sites, products/services, design authority, outsourced processes, policy, process list
2. SCOPE     -> decide requirements not applicable and write the justification (scope-and-exclusions.md)
3. PROFILE   -> write profile.json (format in manual_scaffold.py --help)
4. DRAFT     -> python scripts/manual_scaffold.py profile.json > quality-manual.md
5. COMPLETE  -> replace every TODO with the company's register / procedure references
6. REVIEW    -> python scripts/manual_check.py quality-manual.md   (aim for no findings)
7. APPROVE   -> top management signs; the manual enters document control

What the Manual Must Get Right

ElementRequirementTypical failure
ScopeProducts/services, sites, activities (4.3)"Manufacturing" with no product type; a site missing
Not applicableOnly if conformity is unaffected, with justificationExcluding 8.3 while choosing materials or tolerances; excluding 7.3 (now Awareness)
Process interactionSequence, owners, inputs, outputs, KPIs (4.4)An org chart presented as a process map
PolicyText or reference to controlled copy (5.2)Missing commitments (see policy drafter)
Outsourced processesListed with how they are controlled (8.4)Heat treat or plating not shown
Modern termsDocumented information, risk-based thinkingManagement representative, preventive action procedure

Section-by-section structure, writing rules and the 2008 -> 2015 conversion table: manual-structure.md. Valid and invalid exclusions with example justifications: scope-and-exclusions.md.

Review Codes (manual_check.py)

CodeSeverityFinding
QM001highNo scope naming products/services
QM002highExclusion of a clause that always applies, or without justification
QM003highNo quality policy or reference to it
QM004mediumProcesses and interaction not described
QM005mediumNo revision / approval block
QM006mediumISO 9001:2008 leftovers
QM007lowCopies "the organization shall" instead of describing practice
QM008lowPlaceholders left (TODO, [Company], XXX)
QM009lowClimate-change relevance not addressed (Amd 1:2024)
text
QM002 [high] clause 7.3 declared not applicable; it cannot be excluded (7.3 was design in ISO 9001:2008; design is 8.3 now)
QM006 [medium] 'management representative' was removed in 2015; assign the responsibilities in 5.3

Output Format

When writing or reviewing a manual, deliver:

  1. The manual (Markdown) with scope, exclusions, process table, policy, section pointers and cross-reference.
  2. Open items - every TODO the company must fill, grouped by owner.
  3. Review result - manual_check.py findings and how each was resolved.
  4. Exclusion rationale - why each not-applicable requirement is valid, and what would invalidate it.

Scripts

bash
python scripts/manual_scaffold.py profile.json > quality-manual.md
cat profile.json | python scripts/manual_scaffold.py -

Profile keys: company, sites, products, exclusions (clause + justification), policy, processes (name, type core/support/management, owner, inputs, outputs, kpi, documents, clauses), approved_by, revision. Exit codes: 0 written, 1 invalid exclusion (clause that cannot be excluded or justification under 5 words), 2 read/JSON error.

bash
python scripts/manual_check.py quality-manual.md
python scripts/manual_check.py manual.txt --json

Exit codes: 0 no high findings, 1 high findings, 2 read error.

Additional Resources

FileContent
manual-structure.mdRecommended sections, writing rules, 2008 -> 2015 conversions, process interaction
scope-and-exclusions.mdStrong scope statements, which requirements may be not applicable and when, justification wording
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