Benchmark Innovation Consulting Services (BICS)
Healthcare sector rely heavily on the quality of diagnostic testing provided by Medical Laboratory Services and Pathology Laboratories. The provision of accurate and consistent testing, result validation, interpretation and reporting are essential for patient assessment and directed care. Today’s busy medical laboratories should be aiming to validate their test methodology according to criteria outlined in his target Quality Management System Standards and guidelines. Adopting the new standards will increase confidence in the results produced by eliminating, wherever possible, any causes of variability in test results.
Benchmark-Innovation Consulting services (‘BICS’) has been set up by our leadership consultant to provide clients with professional yet bespoke solutions designed to meet every aspect of their needs as they seek to meet or exceed their chosen management system requirements. Our consultation and leadership will propel you forward and give you the momentum and expertise to make a genuine difference in the quality of your diagnostic healthcare laboratory in your facility or region by applying Risk-based approach.
Since early 2008 BICS has worked almost within healthcare sector where they have provided consultancy and training primarily to assist pathology Laboratories and Proficiency testing scheme to meet CAP and ISO 15189 standards.
BICS ensures its advisory works is founded upon available guidelines such as those from, Clinical and Laboratory Standards Institute (‘CLSI’), German Guidelines for Quality ( ‘Rilibak’) , Institute of Biomedical Scientists (‘IBMS’) and United Kingdom Accreditation Service (‘UKAS’).
Some of the other common healthcare standards currently in place include external certifications such as ISO 22870, ISO 17043, JCI Accreditation, QSI (Quality Standard for Imaging) and many others.
Our many options solutions consist of onsite visit, or remotely via our Cloud web-based solution or Purchas our comprehensive document package tool (‘B.I-1000’). In addition to a guidance support to integrate these tools effectively into your own lab management system and processes.
Onsite consultancy
We are leaders in ISO Accreditation consultants who offer to our clients a wide range of certification and ISO system consultancy services for achieving various prestigious system that help them in accelerating growth and get recognition in the healthcare sector. Offered by a team of healthcare experts, our services are known for their effective results and help clients in achieving the set targets. The scope of services as per certification steps offered by us includes:
Phase 1. Snapshot the current situation by “Gap Analysis” to identified gap and action items.
Phase 2. Appoint a staff member who is responsible for coordinate all tasks and work as a Quality Project Team.
Phase 3. System awareness training and certified auditor training.
Phase 4. Prepare for accreditation, establish management system documentation and Implementation of standard requirements.
Phase 6. Practical training for internal auditor and mock auditing of all departments
Phase 7. Submit Application to Accreditation body
Phase 8. Internal audit and management review meeting
Phase 9. Final mock external audit and actions on findings.
Remote consultancy
Our online consultancy design for automatically and systematically guiding your medical laboratory to prepare for an ISO-based management system. you can document all activities required by relevant ISO, and thereby produce the required “Traceability” to conform to the standards. Our system relieves you from your battle against paper: Spare yourself error-prone, manual documentation and linking of the documents and activities for the Standard .. It consists of the following modules, as given below:
Module -1 Admin
Module -2 Laboratory management
Module -3 the personnel documentation and training
Module -4 Equipment –
Module -5 laboratory inventory & suppliers’ information Management
Module -6 IQC, EQA, audits, reviews management
Module -7 Meetings
Module -8 Tasks
Module -9 Document control
Module-10 Consumables & Reagents management
Module -11 Non conformances
Module -12 Help
-Total consultancy is provided through our cloud web-based solution, 24/7 customer service via hot number for urgent issues and videoconferencing.
-We can provide complete consultancy within a short period of time. We complete the work in 3 to 4 months’ time.
Help for self-help (for ISO 15189:2012)
If you need to establish and implement your Quality Management System by your own, then great! Perhaps you only require having the personnel with the talent and expertise needed in addition to our comprehensive document package (B.I-1000 - The Entire Quality Management System) to provide the framework and structure to your facility. Our package gives you all you need to start from scratch to establish your management system till submit your application to accreditation body. Our package can be used as a ready-reference tool to complete documentation process. This readymade documentation package for medical lab's
Help you prepare quality manual, procedures, SOPs, exhibits and forms needed for quality management system and saves you hundreds of hours of non-patient workload hours!
-On realization of payment, we deliver Package online within 24 hours. We send username and password by e-mail and users can download the products from our server.
-On receipt of our products, you can make changes and modify the documents/ according to your requirements and your management system will be ready within a few days.
Send us the details of your facility(ies) and the scope of your Lab activity so we may provide a proposal to you to start the development of your Quality Management System. As a Leadership consultant we are willing to dedicate ourselves to your endeavor and customize a customize plan to suit your needs. With planning and implementation. With our experience, we’ll help you to set priorities and provide realistic scheduling to get you on your feet
European IVDR Consulting Service to IVDR (2017/746) Transition
The changes under Europe’s new IVD regulation are significant, including the need for Notified Body involvement, a greatly expanded definition of what is considered an IVDR, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates, and more rigorous post market scrutiny.
IVD manufacturers who conduct business in the EU must start their transition or implementation of the new regulation now in order to meet the May 26, 2022 deadline. In our consultancy Journey, you’ll learn about the significant new requirements found in the IVDR, their impact on manufacturers, and how to plan an effective and efficient implementation of to the IVDR include: -
Preparing to IVDR Impact Assessment
Device classification review
New rule-based risk classification compared to current IVDD list-based classification
New/updated required documentation
Performance evaluation plans and reports
Post-market surveillance plans and reports
Technical Documentation Gap Assessment
EU IVDR provides more specifics of what needs to be included in Technical Documentation &Getting your IVD Technical Documentation in shape.
QMS System Gap Assessment
EU IVDR provides more specifics of what needs to be included in a manufacturer’s quality management system (QMS) that is compliant with ISO 13485:2016.
Notified Body Submissions/Reviews
All devices require Technical Documentation, UDI, and post-market surveillance.
Notified Body conformity assessments required for most classes of devices and implement Notified Body mock audits to test your level of preparedness