Hi folks
I manage an ISO13485 system in an NHS organisation. We custom make or modify accessories for medical devices; mainly seating systems, foot pads, guards, headrests etc for wheelchairs. We have a workshop with 14 pieces of machinery in it, as well as a wide range of hand tools. We employ 3 staff who can use all of the workshop machinery, but also other staff (around 10 qualified rehabilitation engineers) who might pop in to the workshop to use 'some' pieces of equipment for modifications they have prescribed.
As part of my system I want to establish a more compliant way of defining who can do what / how / when in relation to using certain machines, and have a system for managing workshop competence.
My background is more clinical and managerial than mechanical, so I'm struggling a little with how to approach this. The technicians are all qualified (all qualified in mechanical engineering, all over 30yrs ago), but are not registered with an accreditation body / they dont do much continuous professional development other than that mandated by the NHS. I 'think' they are knowledgeable and safe to do what they do, but how do I clearly demonstrate that? Also, I think 2 technicians are capable enough to observe the practices of rehabilitation engineer colleagues and test their competence in using particular pieces of equipment. Again, how do I pragmatically establish a mechanism for doing this appropriately?
Any thoughts appreciated!
James
I manage an ISO13485 system in an NHS organisation. We custom make or modify accessories for medical devices; mainly seating systems, foot pads, guards, headrests etc for wheelchairs. We have a workshop with 14 pieces of machinery in it, as well as a wide range of hand tools. We employ 3 staff who can use all of the workshop machinery, but also other staff (around 10 qualified rehabilitation engineers) who might pop in to the workshop to use 'some' pieces of equipment for modifications they have prescribed.
As part of my system I want to establish a more compliant way of defining who can do what / how / when in relation to using certain machines, and have a system for managing workshop competence.
My background is more clinical and managerial than mechanical, so I'm struggling a little with how to approach this. The technicians are all qualified (all qualified in mechanical engineering, all over 30yrs ago), but are not registered with an accreditation body / they dont do much continuous professional development other than that mandated by the NHS. I 'think' they are knowledgeable and safe to do what they do, but how do I clearly demonstrate that? Also, I think 2 technicians are capable enough to observe the practices of rehabilitation engineer colleagues and test their competence in using particular pieces of equipment. Again, how do I pragmatically establish a mechanism for doing this appropriately?
Any thoughts appreciated!
James