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Quality Assurance Agreement (Free Download + AI Generator)
Greg Mitchell | Legal consultant at AI Lawyer
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A quality assurance agreement is a written framework that defines how quality will be planned, controlled, verified, and documented between parties who make, supply, test, or maintain a product or service. It is most often used when quality outcomes are mission-critical — regulated manufacturing, nuclear and energy work, medical devices, pharmaceuticals, laboratories, or software with safety and security implications. A well-structured agreement clarifies responsibilities for audits, testing, corrective actions, change control, record retention, and certifications — so quality isn’t “assumed” or handled through scattered emails.
This guide explains qa what is in practical contract terms, how quality assurance standards and quality control standards fit into an enforceable agreement, and which clauses matter most across industries — from ISO 9001 quality assurance to ASME NQA-1 programs, and from laboratory QA to software quality standards. U.S. rules vary by state and sector; this article is informational only and not legal advice.
TL;DR
Makes quality expectations measurable and auditable, not subjective or informal.
Defines inspection, testing, nonconformance, and corrective action workflows to reduce disputes and rework.
Aligns certifications and regulatory obligations with clear evidence, records, and audit rights.
Controls change management and supplier quality, which are common failure points in real projects.
Helps both sides prove compliance when customers, regulators, or insurers ask for documentation.
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Disclaimer
This material is for informational purposes only and does not constitute legal advice. Quality and compliance requirements vary by industry, product risk, and state law, and some sectors are governed by detailed federal regulations and standards. Consult a qualified attorney and appropriate quality/compliance professionals for guidance tailored to your situation.
Who Should Use This Document
This agreement is most useful for organizations that need predictable, documented quality across a supply chain or service relationship. It fits B2B relationships far more than consumer scenarios and is especially common where third-party quality assurance certifications or regulated compliance is involved. It can be used domestically or internationally, but cross-border use often requires additional clauses for data transfer, export controls, and local regulatory alignment — especially where suppliers handle sensitive data (see the FTC’s privacy and data security guidance) or where regulated products require documented quality systems (FDA’s overview of the Quality Management System Regulation (QMSR)). For widely used baseline frameworks, many organizations anchor expectations to ISO pages like ISO 9001:2015 and, in device manufacturing contexts, ISO 13485:2016. In nuclear quality assurance contexts, ASME’s references to NQA-1 and its NQA-1 certification program often shape auditability and documentation expectations.
User type | Typical use case | Notes |
|---|---|---|
Manufacturers and suppliers | Supplier quality, incoming inspection, traceability, corrective action | Often paired with purchase terms, audits, and record retention |
Regulated industries (medical/pharma/food) | GMP/QMS alignment and quality release responsibilities | Frequently needs sector-specific regulatory references |
Energy/nuclear projects | Nuclear quality assurance programs and audit evidence | Often tied to ASME NQA-1 expectations and customer QA manuals |
Software and IT vendors | Testing, release criteria, defect handling, and security-related quality | Often tied to software quality standards and SQA processes |
Laboratories and testing facilities | GLP-style study integrity, documentation, and repeatability | Requires strong data integrity and sample handling controls |
Use a quality assurance agreement when you need audit-ready proof of consistent quality — particularly for regulated products, critical suppliers, software releases, or laboratory outputs — because it ties standards (ISO/NQA-1/FDA/QMS), evidence, and corrective-action responsibilities into one enforceable framework.
What Is a Quality Assurance Agreement?
A quality assurance agreement is a contract-level document that defines quality responsibilities, standards, and evidence requirements between parties. It turns “we follow a QMS” into enforceable obligations: what must be tested, how acceptance works, how deviations are handled, when audits occur, and what records must be retained. Many organizations anchor this structure to common frameworks like ISO 9001:2015 and the broader ISO 9000 family.
In regulated sectors, the agreement often maps to specific regimes. For medical devices, quality requirements are shaped by FDA’s QMSR and the rule text in 21 CFR Part 820, and many programs also reference ISO 13485:2016. For pharmaceuticals, parties commonly align controls with FDA’s cGMP regulations overview. Laboratories may align documentation and integrity expectations to OECD’s GLP principles.
The agreement should also distinguish quality control standards (test/inspection results) from quality assurance standards (the system that ensures those checks are planned, executed, and improved). For software, that can mean defining testing evidence and release gates aligned with standards like IEEE 730. For nuclear quality assurance, it may reference ASME’s NQA-1 standard and the NQA-1 certification program.
A quality assurance agreement makes quality measurable and auditable by mapping the applicable standards, defining evidence and records, and assigning responsibilities for acceptance, deviations, audits, and corrective actions.
When Do You Need a Quality Assurance Agreement?
You need this agreement when quality failures would create disproportionate risk — safety harm, regulatory action, product recalls, mission interruption, or significant rework costs. It also becomes essential when quality responsibilities are split: supplier vs. buyer, developer vs. integrator, laboratory vs. sponsor, or manufacturer vs. contract manufacturer. In practice, the agreement is how parties prove that “quality assurance is” a controlled system rather than a promise, often by tying obligations to recognized frameworks such as ISO 9001:2015 (and the broader ISO 9000 family). In regulated environments, triggers often align to sector regimes like FDA’s medical device quality requirements (see FDA’s QMSR overview and the rule text in 21 CFR Part 820) or FDA’s pharmaceutical quality framework described in its cGMP regulations resources. In nuclear quality assurance contexts, the need is often driven by ASME NQA-1 program expectations (see ASME’s NQA-1 standard page and the NQA-1 certification program).
Use this agreement when any of the following apply:
The supplier’s performance affects safety, compliance, or downstream production, and you need defined acceptance evidence and traceability (often aligned to ISO 9001 or, for medical devices, ISO 13485:2016).
You require proof of certifications or audit readiness (for audit competence, many programs reference ASQ’s Certified Quality Auditor (CQA)).
The product/service includes software releases where testing, defect severity, and release gates must be defined (a common reference for software QA processes is IEEE 730).
You outsource testing or laboratory work where study integrity and documentation are essential (OECD’s GLP principles are a common reference baseline).
The supplier can change materials, processes, equipment, software versions, test methods, or subcontractors — so you need enforceable change control, CAPA triggers, and record retention requirements tied to your compliance posture (for broader regulatory expectations about safeguarding sensitive QA records and systems, the FTC’s privacy and data security guidance can be a practical baseline when data access is involved).
You need a quality assurance agreement whenever the cost of failure is high or compliance evidence is required — because it converts standards (ISO/FDA/cGMP/GLP/NQA-1/IEEE) into enforceable acceptance, audit, change-control, and corrective-action obligations that can be verified and documented.
Related Documents
Quality agreements usually operate as part of a wider compliance and delivery set:
Related document | Why it matters | When to use together |
|---|---|---|
Sets commercial terms, pricing, and scope | Almost always | |
Quality manual / QMS documentation | Explains the provider’s internal system and procedures | When audits or certifications are referenced |
Audit plan and audit reports | Documents audit cadence, criteria, and findings | When ongoing oversight is required |
Specifications and test methods | Define product/service acceptance criteria | Always when “quality” must be measurable |
Defines corrective and preventive actions workflow | When deviations and nonconformance are expected | |
Change control procedure | Controls process/material/software changes | Any evolving product, process, or software |
Defines how long QA records are kept | Regulated or high-risk environments |
What Should a Quality Assurance Agreement Include?
A strong agreement turns “quality” into enforceable requirements: standards, evidence, approvals, and accountability. It should map which quality assurance standards apply and how compliance is proven — often anchored to ISO 9001:2015 and, where relevant, sector overlays like FDA’s device quality framework (FDA QMSR overview; rule text at 21 CFR Part 820) or nuclear QA expectations tied to ASME’s NQA-1 standard.
Scope, definitions, and standards mapping
Define what products/services and sites are covered, then list required standards (e.g., ISO 9001, ISO 13485, ASME NQA-1, software QA standards). Standards mapping prevents “we thought you meant…” disputes.
Roles, release authority, and QMS expectations
Assign responsibilities for inspections, final release, complaints, supplier controls, and subcontractors, and state whether a certified QMS is required (including evidence and lapse notice). Clear roles prevent gaps and duplicated work. For nuclear programs, see ASME’s NQA-1 certification program.
Acceptance criteria, testing, and nonconformance handling
Define measurable acceptance criteria, required tests/inspections, calibration expectations, and the workflow for nonconformance (quarantine, investigation, disposition). Acceptance rules make quality enforceable at delivery.
CAPA and change control
Set CAPA triggers, timelines, root-cause expectations, and effectiveness checks, and require notice/approval for changes to materials, processes, equipment, software versions, test methods, or subcontractors. Change control and CAPA stop recurring failures.
Audits, records, and data integrity
Define audit cadence/scope, follow-up, and acceptable third-party audits; if auditor competence matters, reference ASQ’s Certified Quality Auditor. Require document control and secure record retention; for security baselines use the NIST Cybersecurity Framework, and if QA records involve sensitive data or system access align to the FTC’s privacy and data security guidance. Auditability depends on trustworthy records.
Sector addenda and post-termination obligations
Add sector-specific requirements (e.g., pharma cGMP via FDA’s cGMP resources, labs via OECD GLP principles, software evidence aligned to IEEE 730) and define record retention and handling of open investigations after termination. Post-termination rules prevent quality loose ends.
A complete QA agreement maps standards, defines acceptance evidence, enforces CAPA/change control, grants practical audit rights, and protects record integrity so compliance can be proven — not just promised.
Legal Requirements and Regulatory Context
In the U.S., a quality assurance agreement is usually a contract document, but it often functions as a compliance instrument because it translates standards and regulatory expectations into enforceable processes, evidence, and decision rights. Which rules apply depends on the sector and risk profile, so the agreement should map specific requirements rather than relying on vague “comply with all laws” language.
For broad QMS expectations, many programs reference ISO’s official materials for ISO 9001:2015 and the broader ISO 9000 family. In medical devices, quality obligations are shaped by FDA’s QMSR overview and the rule text in 21 CFR Part 820, with common QMS alignment to ISO 13485:2016. In pharmaceuticals, quality programs typically align to FDA’s cGMP resources and related regulatory text in 21 CFR Parts 210–211.
In nuclear quality assurance, obligations may be tied to ASME’s NQA-1 standard and the NQA-1 certification program. Laboratory QA may reference OECD’s GLP principles and, when applicable, FDA’s nonclinical lab GLP rule at 21 CFR Part 58. For software, teams may align SQA evidence to standards like IEEE 730 and software quality models like ISO/IEC 25010. Where QA records include sensitive data or system access, baseline safeguards can be informed by the FTC’s privacy and data security guidance and the NIST Cybersecurity Framework.
A defensible QA agreement names the applicable standards/regulations, specifies the evidence required to prove compliance, assigns audit/release authority, and enforces change-control and CAPA processes aligned to the sector’s oversight model.
Common Mistakes When Drafting a Quality Assurance Agreement
Treating “quality” as a goal instead of a system
Saying “supplier shall ensure high quality” without defining controls produces disputes. Quality must be defined as measurable standards, evidence, and approvals. Anchoring the agreement to an explicit framework like ISO 9001:2015 helps make “quality assurance is” a verifiable system.
Vague acceptance criteria and undefined testing evidence
If the agreement doesn’t specify test methods, sampling, or pass/fail criteria, the parties argue at delivery. Acceptance is where quality becomes enforceable. Use objective acceptance evidence tied to your sector’s baseline, such as FDA’s device-quality framework under 21 CFR Part 820 when medical-device controls are relevant.
Weak change control
Suppliers change materials, processes, or software versions to solve problems fast — and hidden risk enters. Uncontrolled changes cause recurring defects and compliance failures. For high-risk environments, mapping change control to a recognized regime like ASME’s NQA-1 standard (nuclear quality assurance) helps set clear approval triggers and documentation.
Audit rights that are either too weak or unrealistic
No audit access makes certifications hard to verify; overly broad audit clauses are often rejected. Audit clauses should be proportional, scheduled, and tied to follow-up. Defining auditor competence using a recognized credential such as ASQ’s Certified Quality Auditor (CQA) can make expectations practical.
CAPA obligations with no timelines or escalation
If corrective actions can drag on, the system doesn’t improve. CAPA needs triggers, deadlines, and effectiveness checks. For regulated manufacturing context, FDA’s overview of cGMP quality systems expectations is a useful baseline for why timely investigations and closure matter.
The most common QA agreement failures come from missing specificity: name the governing standard, define objective acceptance evidence, require controlled changes, set workable audit access with qualified auditors, and enforce time-bound CAPA — so compliance is provable and repeat defects don’t become routine.
How the AILawyer.pro Quality Assurance Agreement Template Helps
The AILawyer.pro template provides a structured way to turn quality expectations into enforceable obligations. It prompts users to define standards, acceptance evidence, change control, audit cadence, and CAPA workflows — so quality requirements are operational rather than aspirational. It also helps separate general quality system clauses from sector-specific addenda, making it easier to adapt the same template for suppliers, software vendors, laboratories, or regulated manufacturing.
By using a consistent structure, teams can onboard new suppliers faster, compare vendor commitments consistently, and reduce the risk of missing critical elements like record retention, calibration, or subcontractor controls. The result is clearer accountability and fewer “surprise” nonconformance disputes.
Practical Tips for Completing Your Quality Assurance Agreement
Start by mapping the real risks and the evidence you would need to prove control (test reports, calibration logs, batch records, release checklists). Evidence planning is what turns quality into a contract deliverable. For QMS framing, ISO’s official resources on ISO 9001:2015 and the ISO 9000 family are useful, and the NIST Cybersecurity Framework can help when QA records are electronic.
Next, pick standards intentionally — only those you can verify and audit. Common anchors include ISO 9001 and, for medical devices, ISO 13485:2016. Regulated work may require FDA references like QMSR and 21 CFR Part 820, pharma controls via FDA’s cGMP resources, labs via OECD GLP principles, or nuclear programs via ASME’s NQA-1 standard.
Then, make change control and CAPA workable: define notice vs. approval triggers, CAPA timelines by severity, and — if software is in scope — release gates and testing evidence aligned to IEEE 730. If vendors access sensitive systems or QA data, align safeguards with the FTC’s privacy and data security guidance.
Finally, right-size audit rights: set cadence, scope, confidentiality, and follow-up deliverables, and define acceptable third-party audits or auditor qualifications such as ASQ’s Certified Quality Auditor (CQA). Audits only work when they are feasible and tied to documented corrective action.
Focus on auditable evidence, pick enforceable standards, control changes and CAPA, and set practical audit rights — so quality remains provable across suppliers, labs, and software releases.
Checklist Before You Sign or Use the Quality Assurance Agreement
Scope and standards are clearly mapped to the product/service and the applicable sector requirements.
Acceptance criteria are measurable and tied to specific test/inspection evidence.
Change control is defined with clear notice vs. approval triggers.
Nonconformance and CAPA workflows are complete with timelines and escalation.
Audit rights are practical (cadence, scope, confidentiality, follow-up).
Record retention and integrity rules are stated, including post-termination obligations.
Supplier/subcontractor controls are included if third parties affect quality outcomes.
FAQ: Common Questions About the Quality Assurance Agreement
Is a quality assurance agreement required by law?
Not always, but in regulated or high-risk environments it is often the practical way to document compliance responsibilities and prove control in audits or investigations.
What’s the difference between QA and QC in the agreement?
Quality assurance is the system and governance (procedures, audits, CAPA, change control). Quality control is the checking and testing outputs (inspection results, test reports, acceptance decisions).
Can one agreement cover both suppliers and internal teams?
It can, but most organizations use it for external parties and pair it with internal SOPs. External agreements should focus on enforceable obligations and evidence exchange.
How do ISO 9001 and ISO 13485 fit?
ISO 9001 is a general QMS framework; ISO 13485 is specific to medical devices and is more regulatory-oriented. Use ISO pages like ISO 9001 and ISO 13485 for accurate standard references.
What if the supplier refuses audit access?
Consider alternatives like third-party certifications, defined audit windows, remote audits, or tighter acceptance/inspection requirements. If auditability is essential, lack of access is a major risk signal.
How should we handle software vendors?
Define release evidence, defect severity rules, testing responsibilities, and change control. Referencing recognized frameworks like IEEE’s 730 software SQA processes standard can help align expectations.
Do we need legal review?
For regulated industries, nuclear QA, medical devices, pharmaceuticals, or any high-stakes product risk, yes. Sector-specific compliance language is too important to improvise.
Get Started Today
A well-structured quality assurance agreement can prevent costly rework, speed approvals, and make compliance evidence easier to produce when customers or regulators ask. Use the AILawyer.pro template to define standards, acceptance criteria, CAPA and change control workflows, audit rights, and record retention in one consistent structure. Download the Quality Assurance Agreement template or generate a customized version with our AI Document Builder — then have qualified counsel review the final draft for your industry, certifications, and regulatory obligations before signing.
Sources and References
Principles on Good Laboratory Practice
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