AS9102, ISO 13485 and NADCAP scopes for metal part suppliers

This article explains AS9102, ISO 13485 and NADCAP scopes for metal part suppliers in a practical, neutral way: what each standard or accreditation covers, the documentation buyers should expect (including FAI and traceability records), and how scope language affects supplier selection.

Introduction: why AS9102, ISO 13485 and NADCAP scopes for metal part suppliers matter

Clear scope language helps procurement and quality teams separate suitable suppliers from those that merely claim compliance. When a supplier lists AS9102, ISO 13485 or NADCAP on their portfolio, the precise scope — which processes, sites, or product families are covered — determines whether their documented controls match the buyer’s requirements. Understanding AS9102, ISO 13485 and NADCAP scopes for metal part suppliers reduces surprises in audits, FAI packages, and traceability reviews and makes supplier conversations more efficient.

Quick overview: how AS9102, ISO 13485 and NADCAP differ

At a high level, these three frameworks serve different purposes. AS9102 is focused on First Article Inspection (FAI) requirements and ensuring a solid initial record for aerospace parts. ISO 13485 centers on medical-device quality systems, emphasizing traceability and record retention. NADCAP is an industry-managed accreditation program for special processes (welding, heat treat, plating, etc.) with site- and process-level audit criteria. Comparing them side-by-side helps buyers map expectations to supplier evidence.

This article can also be read as a Scope guide: AS9102, ISO 13485 & NADCAP for metal parts, or as practical guidance on AS9102, ISO 13485 and NADCAP requirements for metal processors. It aims to help teams who are Understanding NADCAP, AS9102 and ISO 13485 scopes in metal manufacturing make clearer requests for evidence.

AS9102 explained: scope and FAI basics

AS9102 defines the structure, content, and approval process for First Article Inspection records used in aerospace supply chains. It specifies the items that must be inspected and the supporting documentation (drawings, specifications, inspection results). Suppliers are expected to produce a complete FAI package for new part numbers, significant design changes, or when production moves to a different site or process.

FAI documentation structure and common pitfalls

Typical FAI packages include the Part Submission Warrant (PSW), dimensional inspection results, and evidence of functional test results. Common pitfalls include incomplete traceability of tooling or process changes, mismatched revision levels on drawings, and missing or unsigned PSWs. Buyers should verify that the FAI references the correct drawing revisions, lists special processes (and their NADCAP status if applicable), and includes raw material certifications when required. Review the First Article Inspection (FAI) structure and typical nonconformances when assessing packages to spot common omissions quickly.

AS9102 specifics for metal components

For metal parts, AS9102 attention typically focuses on dimensions, surface treatments, and special processes (welding, heat treating, plating). FAI packages for metal components should show heat-treat records, hardness tests, weld procedure qualifications, and plating thickness tests as applicable. Because metal processing can vary by site or equipment, the FAI must clearly link process controls to the exact production lot and site.

ISO 13485 explained: medical-device traceability focus

ISO 13485 defines quality-management system requirements for organizations that design and manufacture medical devices or their components. A central theme is end-to-end traceability: from raw materials and components through processing, assembly, inspection, and final release. The standard expects documented procedures for identification, traceability, and retention of records needed to investigate nonconformances and support regulatory submissions.

Traceability depth, lot genealogy and record retention norms

Traceability can be described at multiple levels: supplier lot to part lot, process step records (e.g., furnace cycle logs), and final device assembly linkage. ISO 13485 commonly requires retention periods aligned with regulatory needs (often several years) and documentation of lot genealogy. For metal processors, this means keeping certificates of conformity, heat-treatment records, plating batch logs, and any inspection reports tied to individual lots or serial numbers. Consider documenting a traceability matrix, lot genealogy and record retention periods in vendor files to make retrospective investigations straightforward.

ISO 13485 expectations applied to metal processors

When a metal processor supports medical-device manufacturers, buyers should expect procedures for handling nonconforming material, traceable labeling of lots, and documented change control for process parameters. Records should allow a buyer to trace a finished lot back to raw material certificates and the specific process cycles used — essential when an implantable device or critical surgical instrument is involved.

NADCAP explained: special-process accreditation in metals

NADCAP evaluates and accredits suppliers for special processes that are difficult to control by inspection alone — such as welding, heat treating, chemical processing, and plating. NADCAP accreditation is process- and site-specific: approval typically lists the exact processes, specifications, and locations covered. Buyers use NADCAP status to gain confidence that a supplier’s special-process controls and audit evidence meet program criteria.

Interpreting NADCAP scope statements for welding, heat treat, plating

NADCAP scope statements specify which special processes at which sites are accredited and to which specifications (e.g., AMS, ASTM). Read the scope carefully: welding accreditation might apply to certain weld types and materials but exclude other alloys; heat-treat accreditation might be limited to specific temperature ranges, fixtures, or part geometries. Always verify whether the accreditation covers the exact combination of process, material, and part configuration you require.

Scope vs site-specific accreditation: what to watch for

Terms like “corporate certificate” or “facility-wide approval” can be misleading. NADCAP tends to be explicit about sites and processes; ISO 13485 certificates may be granted at a certified site but not extend to all locations in a corporate group. Buyers should confirm whether the certificate or accreditation covers the manufacturing site that will produce their parts and whether specific processes or product families are in scope. Pay particular attention to the distinction of site-specific accreditation vs scope-wide certification when mapping certificates to production locations.

Audit cycles, surveillance, and re-accreditation timelines

Understanding audit cadence is important for assessing ongoing compliance. NADCAP uses scheduled audits and may perform surveillance or special audits triggered by nonconformance. ISO 13485-certified bodies typically have periodic surveillance audits (often annual) with full re-certification every three years. AS9102 is process-driven: FAI expectations are triggered by part or process changes rather than a regular audit schedule. Ask suppliers for recent audit dates, findings summaries, and corrective actions.

How scopes influence supplier evaluation and contracts

Scope statements should map directly into contract language and acceptance criteria. Include required certifications and scope detail in purchase orders: site of manufacture, required NADCAP processes, necessary FAI deliverables under AS9102, and ISO 13485 traceability expectations if parts feed medical devices. Define what evidence is acceptable (e.g., current NADCAP certificate copy, recent audit summary, or a complete FAI package) and set remediation steps for out-of-scope production.

Common documentation gaps and risk areas

Frequent gaps include missing process linkage in FAI packages, incomplete lot genealogy for plated or heat-treated parts, and NADCAP certificates that don’t cover the specific alloy or process variant. Another common issue is mismatched revision levels among drawings, specifications, and FAI records. These gaps can delay part acceptance and complicate root-cause investigations.

Mitigation checklists for procurement and quality teams

• Request copies of current certificates and the NADCAP scope PDF showing site and process.
• Require an AS9102-compliant FAI package for new part numbers or significant changes.
• Ask for lot genealogy linking raw material certificates to finished parts, with process logs where applicable.
• Include revision-level checks in incoming inspection and contract clauses for scope changes.
• Set timelines for corrective action and re-inspection if evidence is incomplete.

Practical comparison: sample checklist for selecting a metal parts supplier

Use a short, consistent checklist when evaluating suppliers. Key items include: verified site coverage for NADCAP processes; evidence of AS9102 FAI capability (example FAI package); documented traceability procedures aligned with ISO 13485 where applicable; recent audit summaries; and process capability data for critical characteristics. A scored checklist makes supplier comparisons objective and repeatable.

Case example: reading a scope statement and FAI package

Imagine a supplier lists NADCAP plating and provides an AS9102 FAI for a new implant housing. Check that the NADCAP scope lists the plating specification used in the drawing and that the FAI package includes plating thickness test reports tied to the lot number. Verify the FAI references the correct drawing revision and includes raw material certificates and any heat-treat logs. If any item is missing, request supplementation before acceptance.

Next steps: how to request evidence and verify claims

When requesting evidence, be specific: ask for the latest NADCAP scope PDF showing site and process, an AS9102 FAI with PSW and signatures, and material/process records tied to lot numbers. Verify certificates against accreditation databases where possible and keep copies in procurement files. If verification raises questions, request a site-specific audit or conditional acceptance with hold points until evidence is complete.

Consider asking suppliers or internal stakeholders these focused questions to clarify coverage:

• How do AS9102, ISO 13485 and NADCAP scopes differ for metal part suppliers?
• What FAI documentation does AS9102 require for metal components and common pitfalls?
• How to evaluate metal processors: interpreting NADCAP special-process scope and ISO 13485 traceability expectations.

Conclusion and resources

Understanding the differences among AS9102, ISO 13485 and NADCAP — and how their scopes are written — reduces downstream risk when sourcing metal parts. Focus on site and process coverage, completeness of FAI and traceability documents, and alignment between contract requirements and supplier scope statements. For deeper reading, consult the official AS9102 guidance, ISO 13485 standard summaries, and the PRI/NADCAP website for accreditation details.