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What auditors expect from approval workflows under ISO 13485 and FDA quality system requirements

What Auditors Expect from Approval Workflows (ISO 13485 & FDA)

Approval Workflows are often treated as a final checkbox.In reality, they’re one of the first places auditors look when assessing how decisions are made inside your QMS. Auditors don’t review approvals in isolation.They examine the structure behind them — roles, sequence, versions, rationale, and traceability.… 

Professional woman in a home office using a laptop and headset, representing the logistical and technological challenges of conducting remote QMS audits.

Remote audits – what are the limits?

A remote audit, also known as virtual audit, is the method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence, just like during an on-site audit.  The overall aim is to evaluate this evidence objectively to determine the… 

A professional auditor in glasses working at a laptop and taking notes, representing the benefits of remote auditing such as increased efficiency and cost flexibility.

Benefits of remote auditing

Remote audits may have many benefits when it comes to efficiency, access to competence, increased reach and mitigating risks. But companies have to use it in the right context. The main benefit of remote auditing is cost flexibility. Auditors will incur fewer costs through every remote audit they conduct, such as… 

A professional woman wearing a headset and working at a laptop, representing a remote audit conducted via teleconferencing technology to maintain QMS compliance.

Do remote audits becoming ‘new normal’?

Audits are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system performance, evaluating the adequacy and effectiveness of the quality management system; etc. A remote internal audit is usually done partially or completely off-site employing… 

A large, diverse team of medical device professionals sitting at a long conference table with laptops, representing a coordinated effort for a remote QMS audit and virtual facility review.

How to do an Offsite Audits

An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation  Prior to starting the offsite audit, most likely you, a medical device company, would need to provide copies of your quality manual, procedures, complaints,… 

Remote Audit

Do remote audits becoming ‘new normal’? What are the benefits of remote auditing and what are their limitations? About all that and more, you can find out in our whitepaper.