Thomas John Rose's activity
In group: Quality Management in Healthcare
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Thomas John Rose posted an update in the group Quality Management in Healthcare 2 weeks, 1 day ago
PAS 1616, ISO 15189, ISO 9001, and BS ISO 7101 can ALL be implemented with a Integrated Management System (IMS) using the Annex SL Framework. With the right design the following standards can also be included: The General Pharmaceutical Council’s Standards for pharmacy professionals May 2017 and The Royal College of Radiologists’ Standards. Other Standards ca also be part of the IMS. I would advise that this is the way to go and planning should start now.
I learnt this week that ISO15189 Quality and Competence in Medical Laboratories is not a classed as a management standard by ISO so doesn’t comply with Annex SL nor are there any plans for it to do so. However, it is based on ISO9001 and ISO17025 which apparently are management systems. All feels a bit odd.
Nigel
Interesting to hear Nigel. Am I right to think 15189 is based on ISO/IEC 17025 and ISO 9001, what is missing from 15189 that led ISO to decide that it shouldn’t be classed as a MS?
Sorry I deleted my reply in error. I’ll re-post if I can remember what I said!
Hi Tom, sorry for my ignorance and I may have misunderstood this completely. While 7101 applies to the entire hospital, how does it address the differing requirements across disciplines in the hospital, particularly those with very specific regulatory needs e.g. radiation regulations relevant to radiotherapy and imaging department, human tissues authority etc? How 7101 covers all possible disciplines? Who would be the ‘competent authority’ to determine whether the client hospital is compliant, given there are over 40 disciplines within a hospital? What is the role of UKAS and how about the competencies assessment of all the certification bodies in the market?
Oops I just deleted my post by mistake. I’ll re-do it in the morning. Did you, by any chance, have a copy by email? The different requirements are addressed by their own standards like 15189 and 17025 for example. 7101 or 9001 just cover the MS. Key is the process documentation and process management – I keep going on about the importance of this. I’m afraid that the NHS are so far behind in this and refuse to take any of it on board. It’s so far way from QI!!! Standards for AI and IT Governance for example, 27001, 27002 and 42001 all use the very same MS framework. As I said previously some very careful design is required and it will take time. 7101, like 9001, is just a MS and not a standard covering the many different disciplines. Standard here are covered by authorities like professional bodies.
ISO17025:2017 is a normative reference for ISO 15189:2022.
Interesting that Nigel said is it not considered to be a management system standard by ISO as we are accredited to it and UKAS have never said that it isn’t, plus it has a whole section on management system requirements which is pretty similar to ISO 17025.
Lesley, I did explain in a previous post but deleted it in error. You may have an email copy of the post. I’ll try to re-post the lost content.