ISO 13485:2016 says in 0.2 Clarification of concepts,
"When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. "
On the other hand, ISO 13485:2003 said in 1.2 Application,
"When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise."
So, ISO 13485:2016 seems not to require documenting a justification for not applying a requirement is qualified by the phrase “as appropriate”, which are required by ISO 13485:2003.
Could someone tell me whether this is correct?
"When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. "
On the other hand, ISO 13485:2003 said in 1.2 Application,
"When a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise."
So, ISO 13485:2016 seems not to require documenting a justification for not applying a requirement is qualified by the phrase “as appropriate”, which are required by ISO 13485:2003.
Could someone tell me whether this is correct?