What the template covers
One product, one project, or one contract — not the QMS. The How to use tab distinguishes the quality plan from the quality manual and from a validation master plan, and lists the failure modes: plans cloned from the last project, criteria that say 'meets requirements' with no method or record, tolerances copied out of the specification and revised in only one place. The Quality Plan tab is the skeleton, eight sections. The Worked Example tab completes it for a generic contract-manufactured assembly order, customer approval and first-article hold included.
- Plan header — product or project, customer and contract, plan ID, owner, approvals (customer included where the contract requires it)
- Scope and deliverables — what this plan governs, and what stays with your standard QMS
- Applicable-procedures matrix — activity, governing procedure, record produced, one activity per row
- Acceptance criteria with a verification method, record, and responsible role per criterion — values stay 'per specification'
- Inspection points including what happens on failure, customer property, resources and training, records, and a revision history
A plan is not the manual — or a VMP
The quality manual describes the QMS organization-wide. A quality plan applies it to one case — this product, this project, this contract — saying which procedures, resources, and acceptance criteria apply, and when. The two documents answer different questions, and the plan should lean on the manual's system rather than restate it: the applicable-procedures matrix points at your existing controlled procedures, it does not rewrite them.
It is also not a validation master plan. A VMP governs how systems, equipment, or processes are validated — inventory, risk-based approach, documentation standards, schedule. A quality plan governs the quality activities of one piece of work — what gets verified, by whom, against what, leaving which record. If what you are planning is validation activity, use a VMP instead.
Where ISO 10005 fits
ISO 10005:2018 (Quality management — Guidelines for quality plans) exists as international guidance on developing and applying quality plans — useful if you need more depth than a template, particularly on how plans relate to contracts and to the rest of the management system. Its scope is usefully broad: a quality plan can govern a process, product, service, project, or contract. It is guidance, not a requirement: no standard mandates a quality plan format, and this template is a widely used convention, not a rule.
Two disciplines matter more than the format. First, the plan is a controlled document like any other — ID, version, approver, revision history, managed under your own document control procedure, with the customer's approval added where the contract requires it. Second, the numbers stay home: where an acceptance value lives in a specification, the plan writes 'per specification' and the reference — duplicate a tolerance and sooner or later one copy gets revised while the other silently keeps the old number. Adapt the structure to your own procedures and have QA approve the adapted version. The plan is checked against the contract and against the records it names. A copied tolerance, or a named record that cannot be produced for the lot in front of them, fails both tests.
