Skip to main content
    QHSEtech
    Updated
    All glossary terms
    Content date: · No individual check logged· AI use

    Quality AssuranceQA

    Also known as: QA function

    Definition

    Planned, systematic activities that give confidence a product or service will meet its requirements, such as procedure review, audit and trend analysis.

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

    Scope: QA is activity, not one department, and the QA and QC boundary differs by source. FDA, WHO and EPA wording is sector specific, and the ISO 9000 wording is quoted via NIST.

    Example for your evaluation: Follow one finding from the sampled record review through its nonconformance and corrective action to the trend report and the management review that received it.

    Sources checked: . Examples are editorial illustrations.

    What WHO, FDA, EPA and NIST say about quality assurance

    Quality assurance, or QA, has no single legal definition, and the sources opened for this page word it differently. WHO's main principles of good manufacturing practice (Technical Report Series 986, Annex 2, 2014) describe quality management in the medicines industry as the aspect of management that determines and implements the quality policy. Its basic elements are an infrastructure, or quality system, made of organisational structure, procedures, processes and resources, and the systematic actions needed to give adequate confidence that a product or service will satisfy given requirements. WHO says the totality of those actions is termed QA, that within an organisation QA serves as a management tool, and that in contractual situations it also builds confidence in the supplier. WHO lists QA, good manufacturing practice, quality control and quality risk management as interrelated aspects of quality management. This is general information, not regulatory advice.

    FDA's 2006 guidance on a quality systems approach to pharmaceutical current good manufacturing practice is nonbinding and written for drug manufacturers. Its glossary defines quality assurance as proactive and retrospective activities that provide confidence that requirements are fulfilled, and quality control as the steps taken while a product or service is generated so that it meets requirements. The guidance says current industry practice generally divides the duties of the regulatory quality control unit between QC and QA functions. QC usually assesses incoming materials and finished products, evaluates process performance against specification and decides whether each batch is acceptable for release. QA primarily reviews and approves procedures for production and maintenance, reviews the associated records, and carries out audits and trend analyses.

    Outside medicines, EPA's frequently asked questions on its quality programme define quality assurance as the management of an integrated system of activities covering planning, implementation, documentation, assessment, reporting and quality improvement, so that a process, item or service is of the type and quality needed and expected by the organisation. The same answer defines quality control as the technical activities that measure attributes and performance against defined standards. EPA says its quality assurance managers report on quality to senior management, provide independent oversight and must work independently of the people generating the information. NIST's glossary gives a shorter wording, part of quality management focused on providing confidence that quality requirements will be fulfilled, attributed to ISO 9000:2015 through NIST SP 800-160 volume 1 revision 1. ISO's catalogue lists ISO 9000:2015 as withdrawn, with a 2026 edition available that this page could not read. QA is also a name for software testing, which this page does not cover.

    Sources opened :

    What a quality assurance record holds in software

    • The procedure or specification under review, with its revision, the reviewer, the approver and the date of approval.
    • The records reviewed, such as batch, inspection or service records, with the sample taken and any entry found missing or inconsistent.
    • Audit or self-inspection reports with scope, date, auditor, findings and the evidence examined for each.
    • Deviations, nonconformances and complaints reviewed, with the investigation, the cause found, the corrective action and the check that it worked.
    • Trend analyses: the period, the measure, the result and what was decided.
    • A note of reviewer independence: that the person who approved a record did not produce it, or the extra review arranged where one person holds both roles.

    QA, QC, quality management and an audit

    On this page's own summary, not the sources' wording, QC checks particular materials, products or results against requirements, and QA gives confidence that the system producing them works. The sources do not draw one line for every sector. WHO treats QA as the totality of the systematic actions inside quality management, EPA treats it as managing an integrated system of activities that includes assessment, and NIST, quoting ISO 9000:2015, calls it a part of quality management. A quality unit can hold both functions, and WHO says that can be separate QA and QC units or a single individual or group, depending on size. An audit is one QA activity. WHO describes a quality audit as an examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality management system is the wider structure, covered on the QMS page.

    A hypothetical example: unsigned line checks found in a batch record review

    This case is invented to illustrate the record and describes no real company. A plant with 60 staff packs powdered cleaning products. Its QC inspector tests every batch, and in March every batch met its weight and purity limits. A QA reviewer who works outside production samples 24 batch records for the month to check the line clearance entry that must be signed before filling starts. Three records have no signature, so 3 of 24 entries, or 12.5%, are missing, and 21 are complete.

    The reviewer raises a nonconformance for the three records and asks the line supervisor for the cause. The investigation finds that the paper form changed in February and the new layout puts the signature box on the back of the sheet. The corrective action is to move the box to the front, retrain the 14 line staff and brief the shift leaders, with a check set for the April records. In April the reviewer samples 30 records and finds 1 unsigned, which is 1 of 30, or 3.3%. The action stays open until that record has a cause. The trend is reported to the quarterly management review, where the QC results and the record review are read side by side. No batch was out of specification, which shows that a passing test result and a complete record are separate questions.

    Common misunderstandings about quality assurance

    • QA is not a department by definition. WHO and FDA describe activities, and WHO says the quality unit can be one individual or group, depending on size.
    • QA does not take over the work of production staff. FDA says quality unit activities do not substitute for the daily responsibility of manufacturing personnel to build quality into the product.
    • QA and QC are not split in the same place by every source. FDA divides them between functions, while WHO and EPA word the boundary differently, so use the definition that applies to your sector.
    • A quality programme does not make information good. EPA says information is neither good nor bad, only useful or not useful for its intended purpose.
    • QA is not only looking back at audits. FDA's glossary calls it proactive and retrospective activities.
    • The wording of FDA and WHO is written for medicines. A customer or a standard may use the ISO 9000 vocabulary instead, and its edition should be checked.

    How quality assurance relates to other glossary terms

    QA sits between the checks that produce results and the system that governs them. These terms cover each side.

    • Quality control: the checks whose results QA reviews and trends.
    • QMS: the wider system of processes, responsibilities and records that QA activities support.
    • Non-conformance: the record raised when a review or audit finds a requirement not met.
    • CAPA: the cycle that addresses the cause of a finding and checks that the action worked.
    • Management review: where QA trends and audit results reach senior management.

    Records and evidence that usually exist for quality assurance

    • Approved procedures and specifications with revision history, reviewer and approver.
    • Reviewed records with the sample size and the findings, signed and dated by the reviewer.
    • Internal audit or self-inspection reports with scope, findings and follow-up.
    • Investigation, corrective action and effectiveness check records for each finding.
    • Trend reports showing the data period, the measure and the decision taken.
    • Minutes or outputs of the management or product quality reviews that received them.

    What a software tool needs to capture for quality assurance

    • Review and approval of a procedure or record by a named person other than its author, with the date and the revision approved.
    • Sampling of records for review, with the sample size and the result recorded, not only the findings.
    • A finding that links to its nonconformance, cause, corrective action and effectiveness check.
    • Audit findings that point to the evidence examined.
    • Trend data that can be exported with its period and measure, so the figures can be recomputed.
    • A history of changes that cannot be silently edited.

    Catalog profiles documenting document-control records

    Listed profiles meet the document-control rule used by the QMS document control software guide. That rule does not show that a product supports record sampling, trend analysis or independent review, which should be tested with your own records.

    Same rule for every product: tagged “Document Management”, with a sourced 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 18 matching profiles are shown. Documentation review, not hands-on testing or a claim of compliance.

    Related software

    Frequently asked questions

    What is the difference between quality assurance and quality control?

    FDA's guidance divides them as functions: QC assesses materials, process performance and batch acceptability, while QA reviews and approves procedures, reviews records and carries out audits and trend analyses. WHO and EPA word the boundary differently, so use the definition that applies to you.

    Does quality assurance have to be a separate team?

    No source read says so in general. WHO says a quality unit independent of production can be separate QA and QC units or a single individual or group, depending on size, and FDA suggests an extra independent review where one person holds production and quality roles.

    Is the ISO 9000 definition of quality assurance still current?

    NIST's glossary quotes the 2015 wording: part of quality management focused on providing confidence that quality requirements will be fulfilled. ISO's catalogue lists ISO 9000:2015 as withdrawn and shows a 2026 edition, which this page could not read, so check its current wording.

    More quality terms

    Related guides