by PsyphaDeejay | Sep 2, 2013 | A Short History of Standards - ISO9001 and How We Got Here., General, ISO 9001, Quality Management System
Part Two – Manufacturing, Management and The Military. Armed Conflict changes a lot of things, and it led to the quality management system. Surprisingly, formal Quality Management emerged as an unexpected by-product of global warfare. Close to my home is the...
by PsyphaDeejay | Sep 2, 2013 | A Short History of Standards - ISO9001 and How We Got Here., General, ISO 9001
Part One – Artisans, Victorians and World War No, this is not a cure for insomnia. Hopefully it will help to explain how we got from Mediaeval Artisans to mass-production (and ISO 9001), and how standards have evolved. If you are contemplating attaining any ISO...
by PsyphaDeejay | Jul 2, 2013 | General, ISO 9001, The Diary of an ISO Consultant
What can you compare the job of ISO Consultant to? Occasionally, it seems a very strange job, running an ISO Consultancy. There are parallels with being a vicar, priest, or miscellaneous other minister of religion. Now, I wouldn’t say that being an ISO...
by PsyphaDeejay | Mar 27, 2013 | General, ISO 9001, The Diary of an ISO Consultant
I received a call from a prospective customer. who explained that he’d bought a business which held an ISO 9001 certificate from a reputable certification body. However, he’d identified that discipline within the business wasn’t good, and that most of the staff...
by PsyphaDeejay | Mar 12, 2013 | Archived, General, ISO13485, ISO14971, Medical Device Certification
I’m going to begin with what would normally be my closing comment, that is, there is much, much more to expand on in the whole area of medical device certification, compliance with Medical Devices Directive, with ISO 13485, and ISO14971, etc, etc. What you read...
by PsyphaDeejay | Mar 12, 2013 | General, The Diary of an ISO Consultant
Image copyright Steve Cole. No unauthorised use. From time to time, a scandal emerges which reminds us that although we (supposedly) live in a highly-sophisticated, carefully-controlled, global manufacturing world, things “being right” are only as good as things being...
