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    All templatesQuality · 3 pages · Updated 17 October 2026

    Quality Plan Template

    Three-page quality plan for one project, product, process or contract: plan details and scope, measurable objectives with acceptance criteria, responsibilities, resources, process steps and controls, inspection and test points with hold, witness and review codes, a sampling rule, suppliers, records, a change log, review and approval with a distribution list. A quality plan is voluntary unless a customer, contract or sector asks for one. ISO 10005 is guidance, not requirements; its paid text was not read, and this template does not claim to follow it.

    What's inside

    Page 1: what the plan is for

    1. Plan details — title, reference, revision and date, the case it covers (project, product, process, service, contract or order), customer or internal client, contract number, period of application, site, who prepared it, the plan owner, and the procedures it relies on
    2. Scope — what the plan covers and what it does not, and the revisions of the drawings, specifications and standards the work is built to
    3. Quality objectives and acceptance criteria — each with its source and how and when it is checked, one example row, and a column for the result
    4. Responsibilities and authority — role, name, what each is responsible for, who can accept or reject work and who can approve changes
    5. Resources and competence — equipment, facilities, software and instruments (with calibration status), and the skills or authorisation the work needs

    Page 2: how the work is controlled

    1. Process steps and controls — what is done, the procedure it follows, the controls that must hold, the record made and who is responsible
    2. Inspection and test points — what is checked at which stage, method and acceptance criterion, sample or frequency, point type (H hold, W witness, R review of records), who and which record
    3. Sampling and nonconforming output — the sampling rule, what happens when a sample fails, and where nonconforming output is held and recorded
    4. Suppliers and externally provided items — what is required of each and how it is accepted

    Page 3: records, changes and approval

    1. Records and documents — who makes each, where it is kept, for how long, and whether it is linked to the plan revision
    2. Changes to this plan — revision, date, what changed and why, approval (and the customer's, if needed), who was told, and when work under the change may start
    3. Review of the plan — planned review points and a log: followed as written, results against the objectives, actions
    4. Approval and distribution — prepared, reviewed, approved and customer acceptance with signatures, and an issue list with receipt confirmed

    The section titles, the point-type codes and the example rows are ours, to change.

    What requires or shapes this record

    No source opened for this page makes a quality plan a general legal requirement. ISO's catalogue record calls ISO 10005 guidance that does not specify requirements, a committee paper says ISO 9001:2015 does not specifically require one, and FDA's guidance is nonbinding. A plan can still be required by a customer, a contract or a programme: EPA, for example, requires its environmental information work to follow an approved quality assurance project plan. The sources below say what a quality plan is, what a plan of this kind contains and how it is changed. The sections of this form are our own wording of those ideas and not the text of any standard.

    • ISO 10005:2018, Quality management, Guidelines for quality plans (ISO catalogue record, opened 17 October 2026)

      ISO's catalogue record says the document gives guidelines for establishing, reviewing, accepting, applying and revising quality plans for any intended output, whether a process, product, service, project or contract, in an organisation of any type or size, with or without an ISO 9001 system. It says the document provides guidance and does not specify requirements, is focused primarily on the provision of outputs and is not a guide to planning the development of a quality management system. It lists the third edition of June 2018, last reviewed and confirmed in 2023 and still current. The standard is paid and its clauses were not read, so this form is not built from them and does not claim conformity with the standard. Only the facts above are paraphrased; ISO's text is not reproduced.

    • US EPA, Quality Assurance Project Plan Standard, directive CIO 2105-S-02.1 (PDF, form revision 21 August 2023)

      EPA requires work on environmental information that it does or pays for to follow an approved quality assurance project plan, a formal planning document unique to its project. The standard groups the elements as project management and data quality objectives (including an approval page, a distribution list, project organisation, training and documents and records), implementation (including quality control, calibration and inspection of equipment, and inspection and acceptance of supplies and services), assessment and oversight, and review and usability. The level of detail follows the complexity and use of the results, but the graded approach is not a way to waive a requirement: an element that does not apply is explained. Minor changes are notified to the approver; significant changes may need re-approval, with a revision history page, no work under the changed condition until approved, and notice to everyone affected. The requirement applies to EPA's own programme, not to every plan. Sections 3, 9, 10, 11 and 13 of the form follow this pattern in our own wording.

    • US FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (2006)

      A nonbinding guidance for drug manufacturers (the PDF is dated September 2006; FDA's page lists October 2006). Its glossary defines a quality plan as the documented result of quality planning that is disseminated to all relevant levels of the organisation, and quality planning as a management activity that sets quality objectives and defines the processes and resources needed to fulfil them. It says managers use quality planning to identify and allocate resources and define methods, and that plans should be documented and communicated so people know how their work fits the objectives. That is why the form asks for objectives, resources and methods in separate sections and ends with a distribution list that records receipt.

    • ISO/TC 176/SC 2, Guidance on the requirements for Documented Information of ISO 9001:2015

      A guidance paper from the ISO committee for the 2015 edition of ISO 9001 (the committee site is run by a third party and the paper is a linked document on that page). It lists quality plans and test and inspection plans, separately, among examples of documents that can add value, says ISO 9001:2015 does not specifically require any of them, and says that where they exist they are controlled like other documented information under clause 7.5 of that edition. The supplier scorecard page records ISO 9001:2026 as the current edition, and the 2026 wording was not reviewed here. Control the plan the way your own procedure controls documents.

    Each source checked on 17 October 2026. Not legal advice; check the text in force for your site.

    Field by field

    The form is built so that one plan stays short: it holds the decisions for one case and points to your procedures and work instructions instead of copying them. The section titles, the point-type codes (H, W, R) and the example rows are ours and can be changed; keep the same headings between plans so that plans can be compared and checked.

    Plan title, reference, revision and date
    Why: A plan is a controlled document. Records made under it are linked to the revision in force on the day, so the revision and its date must be clear.
    Common mistake: Editing the plan in place without a new revision, so nobody can say which version a record was made under.
    The case, customer, contract and period
    Why: ISO's catalogue record describes quality plans for a process, product, service, project or contract. Stating which one this is, for whom and for how long keeps the plan to one case.
    Common mistake: One plan for "the company's quality", which is a quality manual or procedure, not a plan.
    Prepared by, plan owner and documents relied on
    Why: The owner keeps it current. Listing the procedures and work instructions it points to avoids copying them, and a copy goes out of date when the original changes.
    Common mistake: Pasting whole procedures into the plan, so there are two versions to maintain.
    Scope and revisions built to
    Why: Says what the plan covers and what it does not, and which revision of the drawing, specification or standard applies. A change to any of them can trigger a change to the plan.
    Common mistake: Writing "as per drawing" with no revision.
    Objectives and acceptance criteria
    Why: A criterion that can be measured is one that an inspector can accept or reject against. The source column says where it comes from: customer, drawing, standard, law or your own decision.
    Common mistake: Objectives such as "good quality" that no check can fail.
    Responsibilities and authority
    Why: Names who approves the plan, who inspects, who can accept or reject work, who can stop work and who can approve a change. EPA's standard also names the outside parties involved.
    Common mistake: Responsibilities given by department, so nobody is the named person when a lot fails.
    Resources and competence
    Why: Equipment, facilities, software and measuring instruments, with calibration status where it affects results, and the skills or authorisation needed. FDA's guidance links planning to the allocation of resources.
    Common mistake: Planning the checks without checking that the gauge or the trained person is available when the check falls due.
    Process steps and controls
    Why: Each step names the procedure it follows, the settings or conditions that must hold and the record it produces, so the plan shows how the output is made without restating the procedure.
    Common mistake: A list of steps with no controls or records, which is a flow chart and not a plan.
    Inspection and test points and point type
    Why: Says what is checked at which stage, by what method and against what criterion, how often and by whom. The H, W and R codes are our example convention for hold, witness and review of records, and a detailed test and inspection plan may be a separate document.
    Common mistake: A witness point with no rule on whether work waits for the witness, so the point is passed without them.
    Sampling rule and nonconforming output
    Why: A sampling rule names what happens when a sample fails, such as inspecting the whole lot, and where nonconforming output is held and recorded under your own procedure.
    Common mistake: A sampling rate with no rule for a failure, so a failed sample is just a failed sample.
    Suppliers and externally provided items
    Why: Names what the case relies on from outside and how each is accepted: a receiving check, a certificate or an audit. EPA's standard has an element for inspection and acceptance of supplies and services.
    Common mistake: Accepting a supplier's certificate without a check that ties it to the lot received.
    Records and documents
    Why: Lists the records made for the case, who makes them, where they are kept, for how long and whether they carry the plan revision. How long depends on your contract and the rules that apply to you.
    Common mistake: Keeping inspection results with no revision on them, so they cannot be matched to the plan in force.
    Changes to this plan
    Why: Records each revision with the reason, the approval and who was told. EPA's standard says no work under a significant change starts until the revision is approved and everyone affected is notified. Whether your customer needs to approve is for your contract.
    Common mistake: Telling the shop floor about the change by word of mouth and updating the plan afterwards.
    Review of the plan
    Why: Planned review points and a log of whether the plan was followed, what the results were against the objectives and what was changed. EPA's standard includes assessments and response actions as part of the plan.
    Common mistake: Reviewing only when something fails, so the plan is never checked while things go well.
    Approval and distribution
    Why: Signatures show who prepared, reviewed and approved the plan and, if needed, that the customer accepted it. The issue list with receipt confirmed shows that those who work to the plan have it.
    Common mistake: Approving the plan but not telling the people who do the work.

    Worked example

    IllustrativeA quality plan for an invented contract: 300 control panels built in six batches of 50 (invented company, people and references)

    SectionEntry
    1 Plan detailsQP-0412, revision A, covering the contract for 300 control panels, built to the customer's drawing at revision C and delivered in six batches of 50. Prepared by the quality engineer; the project manager is the plan owner.
    3 ObjectivesEvery panel passes the functional test and a wiring and labelling check against the drawing; every batch ships on the agreed date; only the drawing revision named in the plan is in use on the floor.
    4 ResponsibilitiesThe project manager owns the plan and approves changes. The test technician accepts or rejects panels. The customer's engineer accepts the plan and any change to the drawing.
    6 and 7 Process and inspection pointsReceive enclosures and components (H1: dimensional check and certificate against the order). Assemble and wire. H2: wiring check of the first panel of each batch. W1: the customer's engineer may attend the first-panel check on batch 1, and work on that batch waits for them. R1: a review of all test records before dispatch.
    8 Sampling and nonconforming outputAfter the first panel, every fifth panel gets the wiring check; every panel gets the functional test. If a panel fails the wiring check, the four panels before it and the next five are checked in full. Failed panels are held in the red cage and recorded on a nonconformance report.
    9 SuppliersEnclosures and breakers come from approved suppliers. Each delivery is accepted by a count, a dimensional check on a sample and the certificate of conformity, which is matched to the delivery note.
    11 ChangesBefore batch 4 the customer changes the label text, so the drawing moves to revision D. The plan moves to revision B, the customer's engineer approves it, the floor is told in a team briefing and the old labels are removed from the line. Work on batch 4 starts only after the approval is on file.
    12 ReviewPlanned after batch 2, after any failed wiring check and before the last batch. After batch 2 the plan was followed except that the first-panel check was done a day late; the action is to put the check on the batch start sheet, owner the test technician, due in a week.

    The plan does not copy the assembly or test procedures; it names them. The figures and rules are invented to show the method and are not recommendations: your sample sizes and failure rules should come from your own risk assessment and your contract.

    When a spreadsheet stops being enough

    A word-processor file and a shared folder work for a few plans with one author. They stop working when many plans are open at once, when the inspection records made under a plan must be matched to the revision in force on the day, when a change needs approval, and sometimes the customer's, before work under it starts, and when the people who work to the plan must be told of each revision and their receipt shown.

    A software record holds a plan per contract, project or product with its revisions, approver and effective date, keeps objectives and inspection points as data that results can be compared with, links records to the revision in force, and keeps a history of changes that cannot be edited silently. Ask what happens to work that is already under way when a revision is issued. The list below applies the QMS, nonconformance, CAPA or document-control rule used by the quality management software guide. Nothing in it shows that a product holds plans per project, sampling rules or customer approvals, so test it with one of your own plans.

    Same rule for every product: tagged “Quality Management”, with a sourced QMS, nonconformance, CAPA or document-control capability in its record, or one the vendor stated to us, labelled as vendor-stated. Documented and conditional capabilities qualify; check the linked scope before treating a module as included.

    Tekmon pays for a sponsored placement (above); its place in this list follows the same rule as every entry. How lists are ordered

    All 33 matching profiles are shown. Documentation review, not hands-on testing or a claim of compliance.