Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition

Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

Event Recap – MLVx Friday In-Focus

On Friday, August 15, the MLVx Friday In-Focus with Sean Smith brought together Leonard (Leo) Eisner, The IEC 60601 Guy, and 110+ professionals from around the globe, including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing medtech manufacturers, regulators, test houses, and standards developers.

We focused on the impact of IEC 60601-1, 4th Edition, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.

The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.

(Full presentation available for download at the bottom of this post.)

Unlock Your IEC 60601-1 Insider Advantage

• Mitigate Risks: Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors
• Accelerated Compliance: Seamlessly integrate evolving requirements into your development pipeline
• Leadership Insight: The IEC 60601 Guy and our expert team track areas of interest for your organization based on draft documents
• Behind Closed Doors: Access knowledge while it’s still being developed
• Ready to Leap Ahead? Let’s turn this insider pipeline into your 4th Edition fast-track

+1-503-709-8328
EisnerSafety.com
Schedule a Free 30-Minute Web Meeting

If you missed the live session, this recap and presentation will help you understand what’s coming — and more importantly, how to prepare.

Are you falling behind on your internal audit or supplier audit plans due to COVID-19, other emergency situations, sickness, travel restrictions, time constraints?  It really doesn’t matter the reason why you can rely on external resources to support your audits plans for internal and supplier audits to keep your QMS on track.

Some items to consider for a remote audit that we like to discuss with our clients up front:

• Are you able to access RA/QA documents & records if you are working from home?
• Are your RA/QA documents & records maintained digitally or can they be pdf’ed?
• Are you able to share RA/QA documents & records during the remote audit live (scroll through on-screen) or share them thru tools like DropBox, Google Drive, or similar so the auditor(s) can review during the audit?
• How do you guarantee the documents you share with the audit team are returned or destroyed?
• What are your confidentiality policies and how will that limit your ability to share documents? 
• What about if your auditor is a foreign national and you have national security requirements you need to follow?
• Coordination of a test run of the selected technology to use for the remote audit to make sure work through issues upfront and deal with bandwidth, contingency planning, live document review, & document sharing.
• This list is going to vary depending on your specific circumstances so have an honest discussion with the auditor upfront and during audit planning to make sure the appropriate preparations and contingency plans are considered.

ISO 19011:2018 allows for remote auditing with the use of technology such as Webex, Zoom, Skype, or other video conferencing services along with document sharing services such as DropBox, Google Drive, Box, and more.  The goal of the remote or the on-site audit is the same to verify objective evidence.

Your auditor should be flexible to work with you for what tech works best for your organization.  Work with the auditor to determine ground rules upfront and ask your auditor to review the following checklist of items well before the audit:

• Audit Plan:  Ask your auditor for an audit plan at least several weeks in advance so you can arrange personnel off-site & on-site.  Will all personnel in the audit be on the same time zone and do you need break out room(s) for multiple auditors?  Ask the lead auditor to list what generic documents they always request for all audits so you can have prepared
  • Quality Manual
  • List/index of all QMS procedures/work instructions
  • Management Review procedure
  • Complaint handling procedure
  • List of complaints since the last audit
  • CAPA procedure
  • List of CAPA open/close since the last audit
  • Internal audit schedule
• Sampling Records:  The auditor will need to sample records like in any on-site audit, so query them how this will be done, which types of records will be needed, and in what format the records should be (example: screenshots of folders showing record files, live shots of records, discuss what works for your existing tech).    
• Sharing of Files:  You should request the auditor be flexible enough to use the technology that works best for your organization unless the auditor is physically unable to use the specific technology.
• Contingency Planning:  What happens if an auditor or auditee gets disconnected or if there are some technical issues?  Come to an agreement on what should be done.
• Agreement of Confidentiality:  How will the documents you share with the auditor be accessed, saved, and discarded after the audit.  See the fourth bullet in the above section.
• Break Times:  An 8-hour remote audit is a long workday and maybe too long of a workday.  When doing a couple of remote audits of more than 2 days long it was noted that it is beneficial for all to shorten the remote audit days to less than 7 hours of audit time.  Also, it is critical to agree on break times including lunch breaks, short stretch breaks, and if other breaks may be needed.
• Test run:  Conduct a test run with the auditor(s) and your team (at least some on-site & off-site members) to test-drive the technology about a week prior to the audit to ensure there are no issues with internet, audio, video, document viewing/displaying, transfer of documents, sharing of files, browser compatibility, headsets, contingency planning, etc.            
• Opening & Closing Meetings:  Will you have all your personnel in one place, or will they be scattered off-site and on-site? If you need to pull together your personnel using an online platform such as Webex, Zoom, or similar.  You’ll want to do a short 5 – 10 minute test run to make sure everyone can call in an make the technology works.  You may want to test it with the auditor to make sure all parties are able to make it work.

This is the time for you to review your internal audit and supplier audit schedules.  We are able to support these with a remote audit to help you keep on track and on schedule.

Feel free to contact us to discuss your needs. Contact Leo Eisner to help you thru this process by scheduling a call with Leo.