The most common case regarding poorly followed procedures is a paper-based system. From tracking, monitoring, updating, accessing, locating, and distributing, paper documents are becoming difficult and tedious to follow up. Document control is often the most critical. Documents drive nearly every operation within a company, and having a paper-based system is getting old-fashioned and underrated, and not reliable.

In order to avoid future mistakes, eQMS is taking the leading solution, since it’s much better to document control in the sense that any needed data easily can be retrieved. It saves costs, it saves time, it increases profit level, improves employee morale and efficiency, it helps an organization make an informed decision, and gives room for better supervision.

We all know how important documentation and records are for QMS. We need to have proof “on paper” of how, why, where,... something was done. Both instructions and records must be properly collected and well organized.

List of documents and records needed for compliance with ISO 13485:2016:

  • 4.1. General requirements
  • 5. Management responsibility
  • 6. Resource management
  • 7. Product realization
  • 8. Measurement, analysis, and improvement

For more details check here.

List of documents needed for compliance with ISO 9001:2015:

  • 4. Context of the organization
  • 5. Leadership
  • 6. Planning
  • 8. Operation

List of records needed for compliance with ISO 9001:2015:

  • 7. Support
  • 8. Operation
  • 9. Performance evaluation
  • 10. Improvement

For more details check here.

Auditing today seems much simpler than before. Offsite audits were known even before the pandemic but became very popular during COVID 19.

How to prepare, what are the necessary elements, as well as an example of offsite audit, read in the next article.

One of the common ambiguities of medical device startups is exactly this:

I have ISO 13485 certification, but the manufacturer of my device does not. Will that be a problem or do I have to change manufacturers?

You are developing your device, you meet all the requirements of the ISO 13485 standard, the most important thing for you is that the device is safe to use and that the market will be delighted with your invention.

Often companies choose an outsourced manufacturer, and here we come to an obstacle. Can the manufacturer omit certification and if so what is the procedure?

Read the full explanation in the article:

We are all aware of how important internal and external audit is.

Due to the pandemic itself, most companies switched to work from home, and so the audit turned into a “Remote audit”.
I can’t say that “Remote audit” was invented because of COVID 19, but I can say with certainty that it spread very quickly among various companies during the previous year and this year.

I am sure that my colleagues will agree with me when I say that for the QMS we always have to find time and ways.
Read the full article on Remote audit as “new normal” here:

A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more, and sounds more, like FDA’s QSR. Yep! If you take “a closer look” you’ll notice many parallels and similarities between the two standards. And for those of us who are diligent FDA QSR quality fanatics, this is actually good news!

Read the full article here.

How do employees see the “audit”?

“Audit” is a word that causes fear among employees in the company.

It is considered a test of a set of strict rules that every employee must adhere to.

And should that be the case?

To avoid unnecessary stress, it is very important to understand why an audit is useful to us and whether we should experience it that way.
Read about it in the article:

What is SaMD?

International Medical Device Regulators Forum (IMDRF) defined SaMD as:

“software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

EN 62304:2006/A1:2015

Like a physical medical device, software must have its own life cycle. The standard that defines the life cycle requirements is EN 62304:2006/A1:2015 (Medical device software — Software life-cycle processes)

EN 62304 requires the following processes to be implemented:

  • Software development
  • Software maintenance
  • Problem resolution
  • Risk management
  • Configuration management

Read the whole article at: “Software as a medical device — life cycle

ISO 13485 standard describes requirements for a QMS where you, as a MedDev company need to show the ability to provide a safe medical device and related services that consistently meet customer and relevant regulatory requirements. …


5 years medical regulatory consultant, before I was food inspector. Writing become my passion. Member of qmsWrappers author team.

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