ISO13485 - 7.4.2 Purchasing information

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing information, i.e. documents (see 4.2.3) and records (see 4.2.4).

Complaint handling and vigilance

• Assistance with Post Market Surveillance activities
• Identification / traceability of products to end users
• Storage conditions at the warehouse and during transport (if applicable)
• Handling conditions
• Packaging and/or labelling activities (if applicable)
• Training of the employee(s) of the distributor(s) on relevant issues of procedures and documentation on above topics