STAY UP TO STANDARD, WITH MIPS

CliniSys Group Ltd. All trademarks are the properties of their respective owners. All information was believed to be correct at the time of publishing. CliniSys cannot be held reponsible for any errors or ommissions.

We comply too!You comply with ISO standards to provide your clients with a guarantee of quality, and so do we! As a company, we are accredited to ISO 9001. This means that we use ISO-certified work processes indeveloping our products for you. We are audited every year, and recertified every three years, with a focus on our quality manual and our processes.

All of our products are thoroughly tested at all stages of development before being released to our customers. These testing stages include testing of all modifications, regression testing of the full system, functional testing of enhancements and validation that the processes are being supported as specified. Before going on general release, we first beta test the software with one or two customers and then complete a controlled roll-out to around ten customers.

Our dedicated laboratory software systems provide full traceabilityof all GxP-related actions and support the wide variety of lab processes requested by the ISO 15189 standard. These include (to name a few): complete traceability from initial lab analysis request to final result distribution; unique identification of patients and samples; confidentiality of results and data security.

Finally, our dedicated staff are instructed in quality standards and guidelines, and every person involved in implementing our products on customer sites has been trained in ISO 15189.

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sales@mips.be

MIPS – A CliniSys Group Company

Sluisweg 2 bus 5B-9000 Gent

Belgium

Tel: +32 (0)9 220 23 21Fax: +32 (0)9 220 48 10

A mark of qualityIn the laboratory, reliability and safety are critical. Accreditation to the ISO 15189 standard ensures consistency in compliance across all disciplines in your laboratory, helping promote greater efficiency and responsibility for better results and service delivery. Ultimately it offers a guarantee of quality service to both requesting clinicians and patients.

But accreditation is also an investment – in time and resources. So you want to make sure your investment is embedded in your laboratory information management systems, supporting the work you have undertaken to optimise your processes and work flows and automating documentation and record keeping. Thus quality becomes an integral part of your process.

MIPS can help you stay up to standard.

Evolving standardsIn 2012, an updated version of ISO 15189 was released. It included both quality management system and technical requirements for clinical laboratories. Greater focus is now given to technical competency, assessing measurement uncertainty and traceability.

What’s more, the updated standard recognises that information systems are essential to the lab environment. Previously, IT requirements had only been included for information purposes; but now, for the first time, IT requirements have been included in the main text of the document, with strict and specific requirements.

The right processesSection 4 of ISO 15189:2012 covers all aspects of laboratory management, from organisation and management, through quality management system requirements, document control, continual improvement and more.

Your laboratory information system is a critical tool to help you meet the requirements. MIPS has over 25 years of experience in the design, development, deployment and support of clinical laboratory information management solutions. Our LIS, GLIMS, supports every step of the sample journey. Embedding your quality processes into the work flows supported by our solutions ensures greater consistency of compliance and greater ease of compliance. Records and reports are only held in one place and in many instances automatically created as a by-product of the process.

Stay up to standard, with MIPSKeeping up with national and international standards gets ever-more complex for clinical laboratories. But with MIPS you have an LIS partner that can support you in successfully achieving and maintaining compliance, against a backdrop of ever more demanding accreditation standards.

Focus on information systemsThe central role IT plays in today’s clinical laboratory is given specific attention in the latest version of the ISO 15189 standard. In section 5.10, requirements for information systems are laid out as an inherent part of the norm. MIPS solutions meet the requirements, ensuring you peace of mind as you prepare for your audit. To give a few examples:

Our software complies with all the functional requirements of the standard, such as patient data protection, audit and traceability.

System requirements are clear, so you know exactly what hardware you need to run the MIPS solution.

Our expert project management and deployment skills ensure that work flows and processes are correctly and accurately implemented.

We provide the necessary training, as well as training certificates for all attendees.

Our software is thoroughly validated in line with the requirements before being installed on a customer’s site.

We provide you with the necessary software validation certificates.

Tailored quality servicesAs a consequence of the large number of new deployments we successfully complete each year, we are continually expanding and enhancing the services we can offer:

We use structured project management methodologies based on PRINCE II and PMI for implementing our products. This includes the necessary objective evidence required for the standard.

Our support SLAs are designed to meet your operational requirements and are clearly documented within our contracts enabling you to accurately measure the quality of support you are receiving.

A test and validation environment set up in your laboratory enables you to make changes to your configuration of GLIMS and test new versions of GLIMS without impacting operations.

We can help you in defining and implementing your verification procedures, now a crucial element in meeting the standard.

We can help you put together the required validation records.

We offer system maintenance and back-up procedures that help prevent potential problems.

We follow strict internal processes to ensure all patient data is carefully protected and we sign confidentiality agreements with you showing commitment to the safeguarding of this sensitive data.

We can plan technical audits and preventive maintenance on your backup and restore procedures, and on your disaster recovery and emergency procedure testing.

We can support you with compliance consultancy services advising on configurations to help improve adherence to the standard.

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