by PsyphaDeejay | May 12, 2020 | Archived, ISO13485, Uncategorised
We’ve been working with companies in the medical device market for over ten years. Gaining approval to ISO 13485, (the quality system standard required for by a medical device business) isn’t easy. It often takes over a year from start to certification for even...
by PsyphaDeejay | Dec 17, 2018 | Archived, ISO Audit Preparation, ISO Consulting, Uncategorised
Recently, I received an enquiry from a customer who needed a new ISO approval. He needed to reply to a tender, and hopefully enter a new market. I specialise in getting businesses approved quickly with concise management systems and minimum documentation.Improvement...
by PsyphaDeejay | Jan 4, 2018 | Archived, ISO 9001, ISO Audit Preparation
CE Marking – Does it apply to your product, or not? Even after a quarter of a century in the quality and standards business, I occasionally get caught out. So Far, So Good. I wrote a Quality Management System for someone recently against ISO 9001, 2015. The senior...
by PsyphaDeejay | Jan 4, 2018 | Archived, GDPR, ISO 27001
Some GDPR ISO 27001 FAQ GDPR ISO 27001 FAQ. Our existing ISO 27001 customers are busy asking us about it. However,there is a forest of information on the ‘net but in our usual fashion, we’ve tried to hack through it and give an uncluttered but basic...
by PsyphaDeejay | Mar 7, 2017 | Archived, ISO PDF Template Download
According to Google, searches for an ISO 27001 Template PDF Download are frequent. Yet the “ISO Free PDF Downloads” we’ve seen are often incomplete and/or overly complex. Sadly, lots of the right words won’t impress an auditor. Our senior consultant was...
