Demonstrates alignment with global GMP requirements, simplifying inspections by health authorities.
Robust, documented programs to prevent insects, rodents, or birds from entering facilities. Rigorous Traceability and Documentation
Because these materials directly touch medicine, environmental control is paramount. Key requirements include: iso 15378 key pointspdf free
ISO 15378 follows a structure that aligns with modern ISO management standards, focusing on continuous improvement and risk-based thinking.
While the official text is paid, you can legally find highly informative, free secondary resources online to help you understand and implement the standard. These include: Key requirements include: ISO 15378 follows a structure
Contract manufacturers, sterilization services, and raw material suppliers must be rigorously audited and qualified.
No more arbitrary AQLs (Acceptable Quality Limits). ISO 15378 requires a statistically justified sampling plan for each critical attribute, linked to patient safety risk. No more arbitrary AQLs (Acceptable Quality Limits)
Strict requirements to identify, evaluate, and control risks to product quality and patient safety (e.g., preventing contamination). Traceability:
Operational planning, customer communication, design/development, control of externally provided processes, production provision, and release of products.
Handling non-conformities, implementing corrective actions, and driving continuous refinement. 3. Key Points and Critical Requirements of ISO 15378
If you pass an ISO 15378 audit, you’ve proven you control patient safety risks that ISO 9001 never touches.