I have just released the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” This post explores insights from the Practical Guide on “risk-based approach,” the varying terminology used to reference it, and the QMS processes that require it. Of particular note, is where the risk-based approach applies (everywhere), but we’re all still wondering what it actually is. The Practical Guide mirrors 13485:2016 in that it begins to discuss the risk-based approach as if the concept has already been defined and already well understood by industry (it’s not). The requirements around the RBA are further obfuscated by the use of the term “appropriate” and what appears to be alternate wording for risk-based approach: “proportionate to the effects.”
Key take-aways include:
• Justify all requirements or quality system elements deemed not appropriate with a written rationale. While a written justification is not required by the standard or Guide, having the rationale documented will help avoid discussions with an auditor debating the “appropriateness” of a particular requirement.
• Interpret “proportionate to the effects” to be synonymous with applying a risk-based approach.
• Apply a “risk-based approach” or justification to every QMS element.
Note these recommendations are based on my own conclusions after reading the ambiguous information available on risk-based approach. The take-aways are not meant to infer a requirement from the standard or guide but rather reflect my own ideas on implementation.
Take a look at the post and let me know your thoughts on risk-based approach and associated terminology.

https://wp.me/p6wmF6-ex

Risk-based approach as clear as mud: The Practical Guide to the ISO 13485:2016 Practical Guide Post 2

This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Pract…

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