The video provided below shows you exactly what you will receive when you purchase our Customer Related Processes procedure (SYS-007).
The following Labeling checklist forms and labeling templates are included with the procedure. These documents are updated for ISO 13485:2016. The following is a list of documents included:
- SYS-007 A, Customer-Related Processes
- FRM-015 A, Sales Order Checklist
Purpose- Customer-Related Processes (SYS-007)
The purpose of this procedure is to ensure that customers’ requirements are determined and met before being transferred into [Company Name]’s operations.
Scope- Customer-Related Processes (SYS-007)
This is the primary document meeting the applicable regulatory requirements defined in Section 7.2 of [Company Name]’s Quality System Manual (POL-001), or provides a referenced matrix to the governing procedure that addresses any areas not directly covered within this procedure.
This procedure is not applicable to:
- customer feedback or complaints, which are covered in SYS-018 Customer Feedback and Complaint Handling
- advisory notices, included in SYS-020 Recalls and Advisory Notices Procedure
- handling customer property included in SYS-013 Servicing.
Requirements for Customer Related Processes as defined by ISO 13485:2016 are color coded BLUE and numbered (ex. 7.2.2) within the procedure for easy auditor identification of where clauses are addressed.
Sales Order Checklist (FRM-015)
The Sales Order Checklist, provides a template for creating customer sales orders as well as documenting customer requirements and post delivery activities.
This form also addresses the determination of requirements related to product and the review of requirements related to product. Both of those areas are required to be addressed and documented for compliance with Clauses 7.2.1, and 7.2.2 of ISO 13485:2016.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
