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    Quality Plan

    Also known as: Project quality plan, Quality assurance project plan, QAPP

    Definition

    A document that sets out, for a specific process, product, service, project or contract, the quality objectives, resources, methods and checks that apply and who is responsible for each.

    Editorial definition: The QHSE Standard, updated 3 October 2026 · https://qhsetech.com/glossary/quality-plan

    Scope: A quality plan is not a quality policy or a quality manual, and ISO 10005 is guidance, not requirements. The wording here is from ISO's catalogue record and FDA, WHO and EPA texts; the text of ISO 10005 was not read.

    Example for your evaluation: Follow one contract's plan from approval, through a change to its checks, to the revision that was approved before work under the changed condition began.

    Sources checked: . Examples are editorial illustrations.

    What ISO's catalogue, FDA, WHO and EPA say about a quality plan

    On this page a quality plan is a document for a specific case that sets out which quality activities, resources and responsibilities apply to it. ISO's catalogue record for ISO 10005:2018 describes guidelines for establishing, reviewing, accepting, applying and revising quality plans for any process, product, service, project or contract, in any type or size of organisation, whether or not it has an ISO 9001 system. The record says the document gives guidance and not requirements, is focused primarily on the provision of outputs, and is not a guide to planning the development of a quality management system. It uses the phrase specific case for the process, product, service, project or contract. The record lists the third edition, published in June 2018 and confirmed in 2023. The standard is paid and its text was not read. This is general information, not legal or certification advice.

    FDA's 2006 guidance on a quality systems approach is nonbinding and written for drug manufacturers. Its glossary defines quality planning as a management activity that sets quality objectives and defines the operational and quality system processes and the resources needed to meet them. It defines a quality plan as the documented result of quality planning, disseminated to all relevant levels of the organisation. The guidance says managers use quality planning to identify and allocate resources and define methods to achieve the objectives. It adds that plans should be documented and communicated so personnel know how their work aligns with quality goals. WHO's main principles of good manufacturing practice, in Technical Report Series 986, do not use the term in the text read. They say a quality manual or equivalent should describe the quality management system, including management responsibilities.

    A paper by ISO/TC 176/SC 2 on documented information in ISO 9001:2015 lists quality plans, quality manuals and test and inspection plans as examples of documents that can add value. It says the standard does not specifically require any of them and that, where they exist, they are controlled like other documented information. The paper covers the 2015 edition, so check the edition you work to. The committee site is managed by a third party.

    EPA uses two kinds of plan. A quality management plan describes a quality programme's structure, responsibilities, lines of authority and interfaces, and EPA organisations must write one. A quality assurance project plan, or QAPP, is a formal planning document describing how environmental information operations are planned, implemented, documented and assessed over a project, with its QA and QC requirements. It is unique to its project, and EPA's standard says the graded approach sets detail by complexity and use of the results but cannot waive a requirement: a non-applicable element is explained. Its elements fall into four groups: project management and data quality objectives, implementation, assessment and oversight, and review and usability. The plan must be approved before information is collected, except in emergency response or under police powers, and significant changes may require re-approval before work under the changed condition begins.

    Sources opened :

    What a quality plan record holds in software

    • The case it covers, such as the contract, project, product or process, with its scope and period.
    • The quality objectives and the acceptance criteria for the output, with their source.
    • Roles and responsibilities, including who approves the plan and who checks the work.
    • The methods, inspections, tests and controls planned, with sampling and the point at which each happens.
    • Suppliers, services and documents the case relies on, and how they are accepted.
    • Revisions with the reason, the approver and the date, and who was notified of each change.
    • The records produced against the plan, linked to the revision in force.

    Quality plan, quality policy, quality manual and quality management plan

    The sources keep these apart. A quality policy is the statement of intention and direction from top management. A quality manual or equivalent, in WHO's text, describes the quality management system. A quality plan is planning for a specific case, which FDA calls the documented result of quality planning and ISO 10005 applies to a process, product, service, project or contract. EPA's quality management plan describes a whole programme, while its project plan covers one project. The ISO committee paper lists a quality plan separately from a test and inspection plan. Terms differ by sector, so ask which document a customer or regulator means.

    A hypothetical example: a plan revised after one lot of brackets fails its check

    Everything in this case is invented and describes no real company. A machining firm with 35 staff accepts a one-off contract for 500 brackets in 10 lots of 50. Its quality plan, revision A, names the inspector, the drawing revision, the approved bar stock supplier and the check: 5 pieces from each lot, which is 10%, measured on three features. The customer's representative approves the plan before work starts.

    In lot 6 one of the 5 sampled pieces is out of tolerance. The plan's own rule is to inspect the whole lot, and that finds 5 failing pieces of 50, or 10%. The 5 are reworked and the cause is a worn tool. The firm revises the plan to revision B, raising the sample to 10 pieces per lot for lots 7 to 10, or 20%, and sends it for approval. No further lot is run until the customer's representative signs it. Inspected pieces then total 25 for lots 1 to 5, 50 for lot 6 and 40 for lots 7 to 10, which is 115 of 500, or 23%.

    Common misunderstandings about a quality plan

    • A quality plan is not a quality manual or a policy. WHO describes the manual as a description of the system, and FDA and ISO 10005 treat a plan as planning for a specific case.
    • ISO 9001 does not specifically require one. The ISO committee paper lists quality plans as documents that can add value, and ISO's record calls ISO 10005 guidance, not requirements.
    • It is not only for certified organisations. ISO's record says ISO 10005 applies whether or not an organisation has an ISO 9001 system.
    • It does not plan the whole system. ISO's record says the guidance is not about planning the development of a quality management system.
    • A plan is not written once. EPA's standard says significant changes may require re-approval, with no work under the changed condition until the revision is approved.
    • The graded approach is not a way to skip elements. EPA says a non-applicable element is explained in the plan.
    • This page does not say what ISO 10005's clauses contain, because the paid standard was not read.

    How a quality plan relates to other glossary terms

    A plan puts the policy and procedures to work on one contract, project or product. These terms sit around it.

    • Quality policy: the statement of direction from top management that plans work under.
    • QMS: the system of processes and records inside which a plan is controlled.
    • Quality control: the checks a plan specifies and the results it collects.
    • Quality assurance: the reviews and audits that test whether the plan is followed.
    • SOP: the written procedure a plan can refer to for a task.

    Records and evidence that usually exist for a quality plan

    • The approved plan with revision, effective date and approver, and the customer's approval where one is needed.
    • A distribution list for each revision.
    • Inspection, test and acceptance records made under the plan.
    • Records of suppliers and services accepted for the case.
    • Revision records showing the reason for each change and that approval came before work under it.
    • Assessment or audit findings on the plan being followed, with corrective actions.

    What a software tool needs to capture for a quality plan

    • A plan held per contract, project or product, with revisions, approver and effective date.
    • Objectives, acceptance criteria and planned checks held as data that inspections can be compared with.
    • Sampling rules that create the inspection records and trigger an escalation, such as full-lot inspection.
    • Approval, including the customer's, recorded before the revision takes effect.
    • Records linked to the plan revision in force when they were made.
    • Distribution of each revision to the people who work to it, with confirmation.
    • A history of changes that cannot be silently edited.

    Catalog profiles documenting QMS, nonconformance, CAPA or document-control records

    The list follows the QMS, nonconformance, CAPA or document-control rule used by the quality management software guide. It does not show that a product holds plans per project, sampling rules or customer approvals, which should be tested with your own records.

    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.

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    Frequently asked questions

    Is a quality plan required by ISO 9001?

    An ISO/TC 176/SC 2 paper for the 2015 edition lists quality plans among documents that can add value and says the standard does not specifically require any of them. ISO 10005 is guidance, not requirements. A customer, contract or regulator may still ask for one, and the paper's edition should be checked.

    What is the difference between a quality plan and a quality manual?

    WHO says a quality manual or equivalent describes the quality management system, including management responsibilities. FDA's glossary and ISO 10005 treat a plan as the documented result of planning for a specific case. The ISO paper lists the two separately.

    What does a quality plan usually contain?

    The sources give no universal list. FDA says plans identify resources and methods to meet the objectives. EPA's standard lists plan elements such as roles, data quality objectives, methods, quality control, calibration, acceptance of supplies and services, and assessments. The contents of ISO 10005 were not read.

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