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 were unaware of their operating processes. But although business had a “sloppy” feel, the product range had potential and sales were reasonable.
He had a discussion with the company’s Quality Manager, who tried to quell his fears, proudly producing a set of internal audits. So everything seemed fine. The certification body visited the next week, audited through the business, gave it an all clear and left. So all was well. Or was it? continue reading »
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 The Medical Devices Directives, with ISO 13485, and ISO14971, etc, etc. What you read below is an executive summary for a very busy executive. It’s an overview and outline, not an answer. But it’s a good starting point. continue reading »
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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 “done right”. Your quality management system suddenly becomes very important. Sadly, standards such as ISO9001 are often only seen to truly “matter” when it’s far too late to change events. continue reading »
ISO 9001 is the International Standard for Quality Management Systems. It encourages a business to establish internal processes and disciplines to ensure that products and services it delivers satisfy the needs of its customers. The standard focuses on requirements which are generic to all businesses so can be used across all industries and types of business.
And What is ISO9001 Certification? What Are The Requirements? continue reading »
The whole Bring Your Own Device trend seems to be “the perfect storm”. A quick Google reveals some interesting and disturbing statistics.
75% of IT directors see BYOD as their major threat.
60% (or more) of all employees are using their own devices at work.
33% see absolutely no problem with doing this in respect of security risks.
Occasionally I wake up in the morning and thank God that I’m not a head of IT. The implications of a breach of security in terms of damage to corporate image, customer relations, and ultimately revenue don’t bear consideration. Or do they? continue reading »
Occasionally, I’m shocked at what companies spend. An MD recently told me he had been quoted £1500 a day for implementing an ISO 27001 Information Security system, with a minimum of 14 days consultancy required, a total cost of £21000. Nice work if you can get it.
In contrast, I recently implemented such a system for a local business for less than £6000, including certification by one of the World’s leading independent bodies. Was it the same? Yes. Did I leave anything out? No. So why the difference ?
And, just one more time, what is ISO 27001? It’s an International Standard intended to establish an IT and Information Security System in a business. continue reading »