JobBOSS Certification under ISO 13485 and FDA QS 21 Parts 11 and 820

Software like JobBOSS is an integral part of many shop processes.  While it may not be as ‘visible’ or ‘apparent’ in many situations, it is often key to scheduling, controling, recording, and maintaining many of the results of work completed in various shops.

As a result, regulatory agencies like the FDA and ISO require proof that the software is in compliance with regulations like FDA Quality Systems regulation 21 Parts 11 and 820 and ISO 13485 if the products from the machine shop are used for registered industries.  Your surveillance audits, and the client audits that are requested by customers to ensure that the supplying shop is in compliance, may include the software such as JobBOSS.  The audit pertains to the actual use of the software in the shop, including installation, maintenance, and upgrade processes.  The auditor looks for proof of due diligence with regard to the above processes and requires proof from the audited organisation.  In software, this proof generally takes the form of screen shots showing unchanged behaviour in major functionality after upgrades have occurred, and various supporting reports and documents.  This constitutes a Quality Assurance program for the software.  The auditor examines these proofs and evidence of the Quality Assurance program to provide a Pass on the audit.

If you have a concern about passing an audit for JobBOSS or have had an audit that has resulted in an NC rating, take a look at our service  to see what can be done and how it can help you pass an audit.  Contact us to follow up.

 

NVP has generated and maintains a regression package for JobBOSS to help organisations pass the audit.  Since it is already built, the cost is restricted to customising it for your situation and gathering up the artifacts as proof.  The cost of updating is borne by NVP.

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