Business System Manual Ltd Lowry Plaza, The Quays, Salford, M50 1 Business System Manual
Doc
DOC 1 Business System Manual 27.02.2018 I.H. Chaudhry
DOC 1 Business System Manual 03/06/2019 Development Dr I.H. Chaudhry
DOC 1 Business System Manual 19/09/2022 Development of Process documents I.H. Chaudhry
Scope of the Management System
Uralensis Innov8 Ltd runs three streams of activity:
Remote histopathology reporting Service:
Uralensis Innov8 provides a high quality histopathology laboratory service which includes the collection of samples from the hospital/ clinic(s) to the laboratory; comprehensive analytical service with external referral as appropriate; access to the PathHub Path Online reporting system and MDT services including the provision of high resolution virtual imaging.
We have been awarded as a framework provider for remote pathology services by the Countess of Chester. This is the only NHS framework for out sourcing in the U.K.
Medical Training Courses: Uralensis Inov8 has a training brand called Pathology Spheres which runs medical courses in the histopathology disciplines. These are face to face courses; it is also looking to run online courses and is working on a range of courses.
Software Development:
Over the last year Uralensis Innov8 has been looking to market their in house software PathHub. Its focus has been on engaging with key stakeholders and is now set to develop the software independently and take it to market.
We are a framework provider for digital pathology services by HealthTrust Europe LLP (19 George Road, Edgbaston, Birmingham, B15 1NU, UK company.secretary@htepg.com) for the last 2 years. This is the only exclusive end to end digital pathology frame in the U.K. We have also been accepted by HTE to provide AI technology to the NHS as one of its key suppliers.
Out of RemoteScopehistopathology
reporting Service:
Our partner laboratory will provide histopathology laboratory services, including specimen processing of wet tissue to H&E slides: inclusive of cut up by a Pathologist or HPC registered BMS, Embedding, Sectioning, H&E slides (irrespective of quantity), Further Work (irrespective of number of quantity), Special Stains and Storage of material.
Software Development:
Doc Number/ Ref Revision Date Summary of Amendments Authorised By New Ver. No.
DOC 1 Business System Manual 27.02.2018 First document
Dr I.H. Chaudhry 1
DOC 1 Business System Manual 03/06/2019 Software Development Dr I.H. Chaudhry 2
DOC 1 Business System Manual 19/09/2022 Software Development Update of Process documents Dr I.H. Chaudhry 3
PathHub provides the Web Application. It out sources the Storage and Security to UKFast/ ANS and BridgeHead.
Context of our organisation
In order to fulfil the requirements of ISO 9001:2015 we have determined the external and internal issues that are relevant to the scope of our management system.
We have considered those interested parties associated with our activities in order to understand their needs and expectations. We have also considered the risk and opportunities relating to our interested parties.
We have documented our findings (see DOC 2).
Leadership
In order to demonstrate our senior management’s commitment to the requirements of ISO 9001:2015 we have developed our Leadership Charter (see DOC 4).
Quality Policy
We have established our Quality Policy in accordance with the requirements of ISO 9001:2015 which is endorsed by our senior management and communicated to all staff, subcontractors and other relevant interested parties (see DOC 5).
Process Interactions
1) Medical Training Courses
Doc Number/ Ref Revision Date Summary of Amendments Authorised By New Ver. No.
DOC 1 Business System Manual 27.02.2018 First document
Dr I.H. Chaudhry 1
DOC 1 Business System Manual 03/06/2019 Software Development Dr I.H. Chaudhry 2
DOC 1 Business System Manual 19/09/2022 Software Development Update of Process documents Dr I.H. Chaudhry 3
Medical Course Design
designProgrammeVenueenquiry
Upload Course to website CourseDeliveryMarketingofPostCourse feedback analysis
Feasability discussed with course director and logistics team
Dates and Marketing Plans
2) Pathology sample collection and reporting
Clinic rota is entered onto Aleatha Path Online system Specimens are transported from the clinic to the lab
Clinics are assigned unique tracking reference so that transport and turnaround times can be monitored
Cases are entered onto Aleatha Path Online and assigned to a Doctor
Cases are listed for MDT where monitoring and audit in place
Determination on repeating the Course
Doc Number/ Date of
Cases go through quality control procedure. Errors are logged and investigated. Reports are downloaded from Aleatha Path Online by the clinic
Audit data sent to customer on a monthly basis
Authorised By New Ver. No.
DOC 1 Business System Manual 27.02.2018 First document Dr I.H. Chaudhry
DOC 1 Business System Manual 03/06/2019 Software Development Dr I.H. Chaudhry
DOC 1 Business System Manual 19/09/2022 Software Development Update of Process documents Dr I.H. Chaudhry
See consultancy report (DOC 76)
Quality Objectives
We have determined suitable Quality Objectives and where applicable these are measurable. We maintain documented information relating to these objectives (see DOC 6). Quality Objectives are subject to review.
Customer Requirements
We recognise the importance in understanding our customer requirements and in order to achieve this we have implemented appropriate methods of communication. Where applicable we will carry out a review of our customer requirements prior to acceptance of their order.
Resources
In order to meet our customer’s requirements, we ensure that we hold adequate resources including process equipment and machinery, hardware, software, competent personnel (employed or subcontracted) and that our activities are undertaken under controlled conditions.
Performance Measurement
Doc Number/ Ref Revision Date Summary of Amendments
DOC 1 Business System Manual 27.02.2018 First document
Authorised By New Ver. No.
Dr I.H. Chaudhry 1
DOC 1 Business System Manual 03/06/2019 Software Development Dr I.H. Chaudhry 2
DOC 1 Business System Manual 19/09/2022 Software Development Update of Process documents Dr I.H. Chaudhry Development
In order to ensure that our products and services are delivered to the highest quality we carry out periodic performance measurement, this includes as a minimum the measurement of conformity for our products and services, seeking feedback from our customers, ensuring the effectiveness of our processes and evaluating the performance of our suppliers.
Improvement
We are committed to ensuring that our management system is subject to improvements and in order to achieve this we analyse performance data and carry out periodic management reviews.
Doc Number/ Ref Revision Date Summary of Amendments
DOC 1 Business System Manual 27.02.2018 First document
Authorised By New Ver. No.
Dr I.H. Chaudhry 1
DOC 1 Business System Manual 03/06/2019 Software Development Dr I.H. Chaudhry 2
DOC 1 Business System Manual 19/09/2022 Software Development Update of Process documents Dr I.H. Chaudhry 3