ISO 13485:2016 states, "As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product."
There are a few different discussions that I've found in the Elsmar Cove forums that include questions on this section, but the topic tends to get overlooked in favor of 7.5.2 - Cleanliness of product. ISO's inclusion of the term "as appropriate" seems to me to indicate that there are circumstances in which this section can be listed as "not applicable" in the scope of a company's quality manual.
When would this section be appropriate and when wouldn't it be? Is this meant to encompass all forms of contamination (chemical, bacterial, etc) or is this section mainly meant for sterile products? For example, if my company makes a low-risk medical device that will not be sterilized and is not likely to be exposed to any hazardous chemicals, should I still be making a process for contamination control?
There are a few different discussions that I've found in the Elsmar Cove forums that include questions on this section, but the topic tends to get overlooked in favor of 7.5.2 - Cleanliness of product. ISO's inclusion of the term "as appropriate" seems to me to indicate that there are circumstances in which this section can be listed as "not applicable" in the scope of a company's quality manual.
When would this section be appropriate and when wouldn't it be? Is this meant to encompass all forms of contamination (chemical, bacterial, etc) or is this section mainly meant for sterile products? For example, if my company makes a low-risk medical device that will not be sterilized and is not likely to be exposed to any hazardous chemicals, should I still be making a process for contamination control?