MEDICAL DEVICES
ISO 13485:2016 Medical Devices
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
FDA 21 CFR 820 Quality System, QMSR as of February 2, 2026
Outlines the FDA’s Quality System Regulation for medical devices, harmonized with ISO 13485:2016 by reference. Companies will need to either obtain copies of ISO 13485:2016 and ISO 9001:2015 (which references ISO 9000:2015 for terms and definitions)
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program allows a single regulatory audit to satisfy the requirements of multiple participating countries. The current countries are: Australia, Brazil, Canada, Japan, and US FDA.
European Medical Device Regulation MDR 2017/745 (MDR)
Establishes safety and performance requirements for medical devices marketed in the European Union.
European In Vitro Diagnostic Medical Devices IVD 2017/746 (IVDR)
Regulates in vitro diagnostic devices in the EU, emphasizing clinical evidence, performance evaluation, and post-market surveillance.
PHARMACEUTICALS
GMP Finished Pharmaceuticals, 21 CFR 210 and 211
Defines current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, for finished pharmaceuticals in the U.S.
MANUFACTURING
ISO 9001:2015 Quality Management System
Focuses on customer satisfaction and continual improvement. Will be upgraded in 2026 with new emphasis on quality culture, ethical conduct, resilience and digital information.
AEROSPACE
AS9100D Requirements for Aviation, Space, and Defense Organizations
Designed for organizations that design, develop, or manufacture aerospace products. Adds requirements for risk management, product safety, configuration management, and prevention of counterfeit parts.
AS9110C Requirements for Aviation Maintenance Organizations
Tailored for companies that perform maintenance, repair, and overhaul (MRO) of aircraft and aerospace components. Emphasizes safety, reliability, and airworthiness in maintenance processes. Includes requirements for documentation, inspection, and traceability of repaired parts.
AS9120B Requirements for Aviation, Space, and Defense Distributors
Developed for distributors who stock and handle aerospace parts and materials. Adds controls for traceability, chain of custody, and prevention of counterfeit or unapproved parts.
HEALTHCARE SERVICES
7101:2023 Healthcare Organization Management
The first international standard for healthcare organization management systems, focused on quality, patient safety, and people‑centered care. Key features include patient‑centered care and respect for human dignity; integration of clinical quality, governance, and leadership accountability; requirements for safety, equity, and access in healthcare delivery; and support for sustainable and resilient health systems.