What is ISO 9001? #
ISO 9001 is the international standard for quality management systems (QMS). It sets requirements for documented procedures, management review, internal audits, corrective action, control of records, and continuous improvement. It is industry-agnostic and is the foundation on which most sector-specific standards (IATF 16949, AS9100, ISO 13485) are built.
What is IATF 16949? #
IATF 16949 is the global quality management standard for the automotive industry, built on ISO 9001 and published by the International Automotive Task Force. It adds requirements around PPAP (Production Part Approval Process), PFMEA, control plans, and supplier management. Most OEM contracts require Tier 1 and Tier 2 suppliers to be certified.
What is AS9100? #
AS9100 is the aerospace-industry quality management standard, also built on ISO 9001. It adds rigorous configuration management, counterfeit-part prevention, first-article inspection, and risk-management requirements. It is required by most prime aerospace contractors for their suppliers.
What is ISO 13485? #
ISO 13485 is the quality management standard for medical-device manufacturers. It overlaps with ISO 9001 but adds requirements specific to regulatory expectations — design controls, sterilization validation, biocompatibility, and traceability of devices and components.
What is FDA 21 CFR Part 11? #
21 CFR Part 11 is the U.S. FDA's regulation on electronic records and electronic signatures. It applies to manufacturers of food, drugs, and medical devices whose records would otherwise be paper. It requires unique user identification, secure audit trails, electronic-signature controls, validated systems, and record retention. NextStation QC offers Part 11 features as an Enterprise add-on.
What is HACCP? #
HACCP (Hazard Analysis and Critical Control Points) is the foundational food-safety framework used worldwide. It requires food manufacturers to identify hazards, establish critical control points where those hazards must be controlled, set critical limits, monitor them, and document deviations. Many food-safety standards (SQF, BRC, FSSC 22000) are HACCP-based.
What is GMP? #
GMP (Good Manufacturing Practice) is a set of regulations enforced by national authorities — the FDA in the U.S., the MHRA in the UK — that govern how pharmaceutical, medical-device, food, and cosmetic products are manufactured. GMP covers sanitation, equipment, personnel, documentation, and process control.
What is GFSI? #
GFSI (the Global Food Safety Initiative) is an industry body that benchmarks food-safety standards. A GFSI-recognized certification — such as SQF, BRC, FSSC 22000, or IFS — is widely accepted by major retailers and saves food manufacturers from being audited against each retailer's scheme separately.
What is BRC? #
BRCGS (formerly the British Retail Consortium standard) is one of the most widely adopted GFSI-recognized food safety standards. It is required by many UK and European retailers and is increasingly common in North America. Like other GFSI schemes, it is built on HACCP.
What is SOC 2? #
SOC 2 is an information-security audit framework developed by the AICPA that evaluates a service provider's controls across five trust criteria: security, availability, processing integrity, confidentiality, and privacy. SOC 2 Type II covers a period of operation (usually 6 to 12 months) and is the standard most enterprise buyers expect from their SaaS vendors. NextStation QC targets SOC 2 Type II certification in year two.
What is the difference between ISO 9001 certified and ISO 9001 compliant? #
Certified means an accredited registrar has audited the organization and confirmed it meets the standard, issuing a certificate. Compliant means the organization believes it meets the standard but has not been independently audited. Customers in regulated industries usually require certification, not just claimed compliance.
What is an audit trail in quality software? #
An audit trail is a tamper-evident, time-stamped record of every action that touched a quality record — who created, edited, approved, or deleted it, and when. ISO 9001 requires audit trails for controlled records; FDA 21 CFR Part 11 makes the requirement very strict. NextStation QC writes an immutable audit log for every defect, CAPA, approval, and wallet transaction.
What is electronic-signature compliance? #
Electronic-signature compliance — most often referenced as FDA 21 CFR Part 11 — requires that signatures applied to electronic records are unique to one person, cannot be reused or transferred, are linked to the record they sign, and capture the signer's printed name, date, time, and meaning of the signature. NextStation QC's Enterprise tier includes Part 11-ready e-signature controls.
What is a controlled document? #
A controlled document is one whose creation, approval, distribution, revision, and obsolescence is formally managed under the quality management system. Examples include work instructions, control plans, calibration procedures, and SOPs. Controlled documents must be retrievable in their current revision and the system must prevent use of obsolete copies.