Charles

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…

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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…

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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.

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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…

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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…

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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…

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Charles

Charles

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