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Tuesday, 29 March 2016

ISO 13485:2016 Quality Management for Medical Devices

Standards last year and this year seem to be like buses, nothing for ages them all come at once, there have been a rush of enhancements to various Standards and most have gone with the new format ISO Annex SL, where all the Standards have ten clauses to allow easier integration.

The long awaited ISO 13485:2016  has just been published, sadly it does not follow the annex SL format but does address risk and opportunity as part of the requirements.

 The revised Standard, applicable to a wide range of medical products from bandages to remote robot surgical systems and everything in between.  Like all the revised standards there is more emphasis on suppliers and the roles they have to play, including products and services; looking at the entire life-cycle of products

There are a number of new elements that have been introduced:

  • Work environment now includes contamination control;
  • Particular requirements for validation of processes for sterilisation and sterile barrier systems;
  • Reporting to regulatory authorities;
  • Actions in response to nonconforming product detected after delivery;
  • Rework;
  • Rules for medical software as a product.
There will be a transition period of three years to allow organisations to take the revised Standard on board.

Organisations that have a combined ISO 9001 and ISO 13485 will have to consider whether these Standards will have to be audited separately as they have somewhat diverged.  This will, of course,  have a cost implication.

Monday, 14 March 2016

Smart Phones and Loss of Data

I was with a client this week in London, and while going through the requirements for transition to ISO 9001:2015, the revised quality management Standard we were visited by the Police. 

No they weren’t coming to get me (or the Client); they were advising local businesses that there had been a number of instances where phones had been snatched from people in the street.  Apparently this has reached almost 100 cases this year alone. The thief riding a scooter or small bike rides up behind the person and snatches the phone from the users ear and then rides away.

Most phones are protected by a pin, but the savvy thief can get round this. A better method is some form of fingerprint or face recognition authentication or better still two factor authentication, where the user enters a password and then must enter a unique one-time code before the phone is useable.
Many companies now allow email and server access through smartphones so the loss of one of these is not only inconvenient but could allow unauthorised access to company systems.

Of course the best way is not to use a phone in the street or look around to see if you are alone before using it but as we all know the number of people with their hands up to their ears with phones is enormous.

Our own phones are complete with software that allows us to remote wipe the phone; this protects the company computer network but does little for the budget when having to purchase new phones.

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