what is the difference between iso 13485 and 21 cfr 820?

Situations where you might consider certifying to both include when medical devices represent just part of your business. Regulatory compliance: ISO 13485 is closely linked to regulatory requirements, especially concerning complaint handling, regulatory notifications and post-market surveillance. Risk management Organizations certifying to the medical device standard will also need to show how they incorporate risk management principles into product realization and post-market feedback. ISO 13485, on the other hand, only requires demonstrating effective implementation and maintenance of the quality system.ĭocumentation: ISO 13485’s documentation requirements are much more extensive than those in ISO 9001. These differences go beyond just not sharing the same structure and include:Īims and outcomes: ISO 9001 requirements are skewed heavily towards ensuring customer satisfaction, while ISO 13485 puts more emphasis on the safety and efficacy of medical devices.Ĭontinuous improvement focus: ISO 9001 now requires manufacturers to show continuous improvement.

QMS requirements: To comply with either standard, organizations will require effective processes and tools for Document Control, Employee Training, Audits and Corrective Action.ĭifferences Between ISO 9001 and ISO 13845Įven though they are similar in many ways, it’s important to note there are significant ways in which they are different.

Customer focus: Both ISO 9001 and ISO 13485 are built around ensuring customer expectations are met.

Plan-Do-Check-Act: Despite the fact that the two standards do not share the same structure, they both use the Plan-Do-Check-Act process approach.

Risk mitigation: More so than previous versions, both standards emphasize the need for organizations to incorporate risk into design and production.

ISO 9001 also shares other similarities with ISO 13485, such as: When you get down to brass tacks, ISO 9001 and ISO 13485 are both essentially about the same thing: helping companies create consistently safe, high quality products. Similarities Between ISO 9001 and ISO 13485 Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications. Clearly there are structural differences, but you may be wondering-how different are they? While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001.

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.

What is the difference between iso 13485 and 21 cfr 820?