The standard is the audit. The records are the answer.
The standards your customers audit you against, and the records WorkCell keeps so you can answer them.
| Standard | Full Name | Who Must Comply |
|---|---|---|
| 21 CFR Part 11 | Electronic Records and Electronic Signatures | Any FDA-regulated organization that keeps required records electronically, including pharmaceutical and medical device manufacturers. |
| AS9100 | Aerospace Quality Management Systems | Organizations that design, produce, or service aerospace products, and the suppliers flowed down to by primes. |
| AS9102 | Aerospace First Article Inspection Requirement | Aerospace suppliers producing a part for the first time, after a design change, after a process change, or after a production break. |
| ASME BPVC | Boiler and Pressure Vessel Code | Fabricators of boilers, pressure vessels, and heat exchangers, and the shops that weld and test them. |
| CMMC | Cybersecurity Maturity Model Certification | Contractors and subcontractors in the defense industrial base whose contracts include the relevant DFARS clauses. |
| DFARS | Defense Federal Acquisition Regulation Supplement | Contractors and subcontractors holding Department of Defense contracts, and anyone in their supply chain the clauses flow down to. |
| EAR | Export Administration Regulations | Manufacturers and exporters of dual-use items, including electronics, materials, and equipment that fall outside the United States Munitions List. |
| FSMA | Food Safety Modernization Act | Facilities that manufacture, process, pack, or hold foods on the Food Traceability List, and the supply chain around them. |
| GMP | Good Manufacturing Practice | Manufacturers of drugs, dietary supplements, cosmetics, and medical products, including contract manufacturers. |
| IATF 16949 | Automotive Quality Management Systems | Organizations in the automotive supply chain that manufacture production parts, service parts, or accessory parts. |
| ISO 13485 | Medical Devices Quality Management Systems | Organizations involved in the design, production, installation, or servicing of medical devices, and their suppliers. |
| ISO 9001 | Quality Management Systems | Any organization that wants to demonstrate it can consistently deliver product that meets customer and regulatory requirements. Often required by customers as a condition of doing business. |
| ITAR | International Traffic in Arms Regulations | Manufacturers, exporters, and brokers of defense articles and related technical data, including subcontractors who never ship anything abroad. |
| NADCAP | National Aerospace and Defense Contractors Accreditation Program | Suppliers performing special processes for aerospace primes, and the shops that subcontract those processes out. |
| NIST 800-171 | Protecting Controlled Unclassified Information in Nonfederal Systems | Any nonfederal organization that processes, stores, or transmits Controlled Unclassified Information on behalf of a federal agency. |
| NQA-1 | Quality Assurance Requirements for Nuclear Facility Applications | Suppliers of safety-related items and services to nuclear facilities, flowed down contractually through procurement documents. |
| PPAP and APQP | Production Part Approval Process and Advanced Product Quality Planning | Suppliers at every tier of the automotive supply chain, before a part is approved for production. |
| REACH | Registration, Evaluation, Authorisation and Restriction of Chemicals | Manufacturers and importers of chemical substances in the European market, and anyone supplying articles that contain them. |
| RoHS | Restriction of Hazardous Substances | Anyone placing electrical or electronic equipment on the European market, and the suppliers who provide components into it. |
What do manufacturing compliance standards have in common?
Nearly all of them ask the same thing: show the record. Whichever standard applies, an auditor wants controlled document revisions, evidence that the process ran as written, objective results from inspection or test, and a closed-loop corrective action trail. The subject matter differs; the evidence requirements rhyme.
Can software make my shop compliant with a standard like ISO 9001 or AS9100?
No. Certification is granted to your organization by an accredited registrar after auditing your processes, and a paper system can pass. Software changes how fast you can produce evidence, not whether you qualify, and WorkCell keeps every record a standard asks for on the job, lot and item that produced it.
How does ERP software help during a quality audit?
An auditor picks a shipment and walks it backward. ERP makes that a query instead of a filing-cabinet search: the order, the drawing revision built to, the material lot and its certification, inspection results, operator sign-offs, and any nonconformance all resolve from one job record.
Which compliance standards apply to my shop?
It depends on what you build and who buys it. Aerospace work brings AS9100, AS9102, ITAR, and DFARS. Automotive brings IATF 16949 and PPAP. Medical devices bring ISO 13485 and 21 CFR Part 11. ISO 9001 underpins most of them, and primes flow their requirements down to you.
What is the difference between a quality standard and an export control regulation?
A quality standard like ISO 9001 or AS9100 is voluntary certification against a management-system specification, audited by a registrar. Export controls like ITAR and EAR are US law governing who may access technical data, enforced by the government. One asks you to prove process; the other restricts access.
Pass the audit with the records you already kept.
Every quantity, inspection, and signature lands on the job as the work happens, so the evidence is there when the auditor asks.