The video provided below shows you exactly what you will receive when you purchase our Customer Related Processes procedure (SYS-007).
When is the Customer-Related Processes Procedure Webinar?
The training procedure webinar will be hosted on August 14, 2024 @ 10:30 a.m. ET (i.e., Wednesday instead of our usual Monday schedule). The webinar will be live, and you will receive login instructions if you purchased the training procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.
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.
What’s included with the Customer-Related Processes Procedure?
The following documents are included with this purchase. This procedure has been updated to the requirements of ISO 13485:2016 and simplified for easier implementation by start-up companies. The following items are included with the purchase of the customer-related processes procedure:
- SYS-007 Customer-Related Processes Procedure
- FRM-015 Sales Order Checklist
- Native slide deck
- Login information for the live webinar (if purchased on or before August 14, 2024)
- Recording of the webinar (after August 14, 2024)
Scope of the Procedure
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.
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