Consulting in quality management and regulatory compliance in healthcare
From the makers of slp.blue. We help laboratories and medical practices keep their documentation in order and stay calmly prepared for audits and inspections.
Who we are and why you can trust us
At slp.blue we have long focused on quality and documentation management in healthcare. We are the makers of the software used today by more than 100 laboratories in 4 countries.
The requirements of the ISO 15189 standard are part of our everyday practice, as are audits and inspections in healthcare facilities. We would like to offer you our many years of experience as consulting services as well.
What services we offer
We offer flexible services that we adapt to the individual needs of every client, and you can choose the scope and focus of the services according to what you need right now.
For medical laboratories
For outpatient practices
External quality manager for medical laboratories
We make sure your laboratory has a working quality management system according to ISO 15189 and stays continuously ready for audits, and we take the administrative burden off its senior staff. We provide the service both to laboratories without a quality manager of their own and as expert support for an existing one.
If you are only now building your quality management system, we will help you set it up and prepare your laboratory for its first accreditation assessment. We will guide you through the whole process of preparation and accreditation step by step.
What we take care of
- Running the quality management system: documentation, directives, SOPs, metrology, controlled documents.
- Internal audits: planning, execution, audit reports, corrective and preventive actions.
- Nonconformity and risk management: records, root cause analysis, management of risks and opportunities.
- Review and monitoring of quality indicators.
- Preparation for accreditation and surveillance visits: pre-accreditation audits, readiness checks, assistance during the assessment.
- Staff training: ISO 15189 requirements, internal auditors, metrologist, quality and risk management.
We run the quality agenda efficiently in our own software, slp.blue. We also provide the service to laboratories that do not use slp.blue. The software is not a condition of our cooperation.
How our cooperation works
Initial consultation
we go through your situation and needs with no obligation
Entry audit
we walk through the workplace and assess the current state
Plan proposal
we write down what needs to be addressed and agree on the scope and the schedule
Implementation and ongoing support
we put the documentation in order and keep you compliant in the future as well
Scheduled and ad hoc internal audits
In smaller laboratories it can be difficult to ensure the impartiality and independence required of an internal audit.
By carrying out the audit independently we provide an objective assessment of the quality system, uncover any shortcomings and identify opportunities for improvement. At the same time you meet the requirement of ISO 15189 and gain the independent view of an experienced auditor without having to build your own staff capacity for this activity.
We can carry out the audit as a one-off according to your current needs, or on a long-term and regular basis as part of ongoing quality management.
Consulting for outpatient physicians
Running a medical practice today means a long list of legal and administrative obligations. We take over part of that agenda so that you can focus on patient care. We help you prepare for and check compliance with the requirements of the supervisory authorities as well as with personal data protection.
Requirements of public health and medicines authorities
- Entry audit of the practice: a review of compliance with the requirements of the public health protection authority and of the medicines regulator, operating rules, cleaning and disinfection plan, handling of hazardous waste, handling of medicinal products.
- Review and preparation of documentation: directives, procedures, documentation ready for an inspection.
- Staff training: hygiene essentials, handling of hazardous waste, obligations relating to medicinal products.
Personal data protection (GDPR)
- An audit of the compliance of personal data processing with the GDPR (the EU General Data Protection Regulation).
- Information duties towards patients and employees, data security, contracts with processors.
- Procedures for handling security incidents, directives, staff training.
Ongoing consulting
- Telephone and e-mail consultations, updates on legislative changes, methodological support.
Why work with us
- Expert assurance and an independent view of how the workplace operates.
- Continuous readiness for audits and inspections, without catching up on documentation at the last minute.
- Time and administration saved for management and staff alike.
- An individual approach based on the size and focus of the workplace, and the option of long-term cooperation.
Trust and impartiality are a matter of course for us. We treat all information entrusted to us by our clients as confidential and take care to protect it. Our work is always impartial, objective and independent, free of conflicts of interest and of discrimination. Our aim is to provide expert and fair services you can rely on.
We provide methodological and advisory support. Responsibility for operations and for meeting statutory obligations remains with the healthcare provider. For binding legal opinions we recommend consulting a lawyer.
What clients say
RNDr. Dagmar Korábová
About the consultant
Marta Hýnarová, LL.M.
Quality Management Solutions Specialist
I have worked with quality management systems for more than 18 years, as a metrologist, an internal auditor and, not least, a quality manager. I actively promote their digitalization. I help organizations implement solutions for controlled documentation and connect the requirements of standards with modern technologies and everyday practice. At the same time I contribute to the development and design of slp.blue features so that they best support both the requirements of quality management systems and the needs of their users.
I have experience setting up and running the quality management system of a smaller hospital laboratory as well as a centrally managed quality management system within a large healthcare group.
I keep developing my knowledge and stay up to date with the current requirements and changes in the field. Besides professional training and following current requirements, I also draw valuable experience from audits of various workplaces. Each of them brings a different perspective, experience and practical solutions that I can then use in my own work.
My goal is to set up a quality management system so that it is simple, understandable for every member of staff and at the same time efficient, so that it fully suits the needs of the particular workplace.
Contact
We will be glad to meet you with no obligation and propose a solution tailored to your workplace.
- Contact person
- Marta Hýnarová, LL.M.
- [email protected]
- Phone
- +420 604 753 119
- Web
- slp.blue
Contact us
Write to us at [email protected], contact Marta Hýnarová directly, or fill in the contact form below. We will get back to you promptly and arrange a date for a no-obligation consultation.