-
shereenmurrah replied to the topic "ISO 14971 standard in risk management" – 4 years, 4 months ago
The risk management plan consists of scope, responsibilities/authority, review reqs and criteria, risk verification, data collection and review (production and post-production). The first 3 clauses are introductory and requirement clauses. clause 4: intended use and foreseeable hazards, estimated risk for each hazardous situation clause 5: evaluation… Read more»