Purchased product

The definition covers more than bought parts: software, outsourced services and items from a sister company outside the quality system all count, even when no money changes hands. Everything in this category falls under the supplier controls of clause 7.4.

product provided by a party outside the organization’s quality management system Note 1 to entry: The provision of product does not necessarily infer a commercial or financial arrangement.

ISO 13485:2016, clause 3.16