I am working with one large Trust to help design and implement a QMS to this ISO Standard. I’m sure that some others may be but I don’t know which. I do no that several other Trusts are interested in the standard as you can see from comments in this SIG. This week I’ll be posting questions and answers from my last webinar. A number of questions…Read more

I am very curious of the adoption of ISO 9001 standards within hospital settings currently, particularly at the ORGANISATION level rather than limited to individual departments or service lines. Having a clear picture helps us examining existing implementations in other UK hospitals, also help identify potential gaps and inform our own approach,…Read more

I believe referring to people as ‘complex’ e.g., in mental health care feels a bit like it says more about the practitioner’s willingness to listen and apply evidenced-based principles to helping the person than it does about the person in distress. All humans are complex. If we develop systems which continually try to improve health care throu…Read more

With respect Tom, design professionals will need to work with clinicians, patients and carers to balance the health care economy. I expect quality and patient safety will require a person-centred approach to be effective. Co-production is imperative, as is asset-based community development, to support unpaid carers having to manage risk at home.…Read more

I don’t disagree but my point is that most Service design activity is about ‘system’ design. Things like IT interface, record keeping, scheduling, data collection, Process Management, Juran’s trilogy, etc. All areas requiring Professional skills. Co-production with Service users comes later in the process, never-the-less it is still very important.

Morning Tom. I appreciate your expertise. A coordinated approach to redesigning service delivery will need to consider local context, the views of service users and founding principles of the NHS.

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

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…Read more

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.