Labtopia Solutions provides full consulting support to organizations wishing to seek or maintain ISO-based quality systems. Labtopia’s consulting services consist of partial or turn-key solutions for every aspect of the quality assurance system. We offer customized solutions based on your exact needs and scope of work.
ISO 9001 is the original quality standard and one of the most widely recognized quality management system certifications. The purpose of the ISO 9001 standard is to continually improve business processes with stringent requirements that help in providing products and services that meet and exceed customer expectations. This standard is widely applicable as any size company in any industry can use the standard for their business practices. ISO 9001 is designed to be dynamic and able to adapt to businesses in different industries to ensure quality management.
ISO 17025 is the quality management system and the international standard for testing and calibration facilities. Regardless of the number of personnel, this standard is applicable to all businesses offering testing or calibration services. It shows competency in producing defensible and accurate test results and data.
ISO 17034 is the quality assurance standard that specifies requirements for the competence and consistent operation of reference material producers. Though previously outlined in ISO Guide 34:2009, the minimum requirements of ISO 17034 were developed by the International Organization for Standardization Committee on Reference Materials and is used by accreditation bodies for the third-party assessment of reference material producers.
ISO 13485 is an international standard that sets requirements for a quality management system specific to the medical device industry. This quality standard ensures that the consistent design, development, production, installation, and delivery of medical devices are safe for their intended purpose. Encompassing a robust system of different regulatory best practices, ISO 13485 provides the medical device industry with a common language and business management framework.