Certifications
Analytical solutions backed by our commitment to quality
Quality certifications
Analytical solutions backed by our commitment to quality
Certification is crucial to guarantee the reliability, precision and validity of analyzes and results. ISO/IEC 17025 accreditation ensures that laboratories meet international standards of quality and technical competence, providing a solid basis of trust for clients and regulators, facilitating the comparability of results at a global level, boosting confidence in international trade and in evidence-based decision-making.
ISO/IEC 17025: International Accreditation Service
MCI complies with the requirements of AC89, the accreditation criteria of International Accreditation Service (IAS) for testing laboratories, and has demonstrated compliance with ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories.
MCI is accredited by IAS as a testing laboratory to provide the services specified in the scope of accreditation TL-1207, which include water sampling, biological analysis of viable airborne and surface particles, determination of microbiological load (bioburden), total coliforms and Escherichia coli, bacterial endotoxin testing, biological indicator analysis, and biochemical microbial identification.
In addition, MCI holds accreditation from International Accreditation Service (IAS) as a calibration laboratory, under Calibration Laboratory CL-316, in accordance with ISO/IEC 17025:2017, for the calibration of volumetric airflow in SAS Air Sampler equipment, ensuring metrological traceability, measurement reliability, and compliance with international standards applicable to critical environments and regulated processes.
View TL-1207 / TL-1446 accreditation and scope (testing laboratory)
View CL-316 accreditation and scope (calibration laboratory)
Essential Costa Rica: Beyond Excellence, a National Commitment
As a licensed Essential Costa Rica company, MCI takes pride in embodying the distinctive values of our country. This certification goes beyond excellence in services and products, it is a commitment to social responsibility, sustainability, and contributing to the overall well-being of the community.
Being Essential Costa Rica means that MCI adheres to ethical and sustainable principles in all aspects of our operations. Our corporate social responsibility policy is reflected in the efficiency and responsible use of resources, as well as in the promotion of the well-being of our employees and the community in which we operate. This commitment is not only a distinction but also a responsibility that we proudly embrace, contributing to sustainable development and equitable growth in Costa Rica and beyond.
Member of the Medical Devices Cluster of Costa Rica
The Costa Rica Medical Device Cluster is a private initiative launched in 2019 with the purpose of bringing together medical device companies with operations in the country.
Its objective is to coordinate efforts, create synergies and promote co-creation spaces that allow Costa Rica to continue strengthening and developing its medical device ecosystem, in collaboration with the government, academia, entrepreneurs and investors.
Quality in production
Our analyses are focused on the microbiological quality of the products and the environments in which they are manufactured.
For the execution of all analyses, MCI bases its methods on international standards.
We know very well the needs of the industry regarding the quality of suppliers, so we are fully willing to receive your requests regarding supplier surveys and questionnaires, provide all the necessary documents for review, and receive your audits, of so that MCI can complete the supplier qualification process.
If you need to schedule an audit or request information for this process, please contact us.
International standards
- US Pharmacopeia (USP)
- ISO 14644, Cleanrooms and associated controlled environments
- ISO 14698, Cleanrooms and associated controlled environments — Biocontamination control
- BS EN 17141, Cleanrooms and associated controlled environments. Biocontamination control
- ISO 8573, Compressed air
- ISO 11737, Sterilization of health care products — Microbiological methods
- ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
- ISO 11138, Sterilization of health care products — Biological indicators
- ISO 10993, Biological evaluation of medical devices
- Standard Methods for the Examination of Water and Wastewater. APHA, AWWA and WEF
Environmental commitment
At MCI we are strongly committed to the environment. For this reason, we have adopted a policy of control and reduction of the impact that our operation has on the environment.
To achieve this, we have developed different actions, among which are:
- Installation of solar panel system.
- Implementation of a digital-only reporting system.
- Waste classification centers to be recycled.
- Awareness campaigns for collaborators on ways to save on the use of water and electricity.
Quality policy
Good practices and international regulations
MCI is committed to offering quality analysis services, meeting client needs and regulatory requirements, through the monitoring of good professional practices and continuous improvement.
Our quality management system (QMS) is based on the INTE-ISO/IEC 17025:2017 standard, policies, procedures and requirements established and applied by staff.
