Regulatory System
LAROVA's Quality Management System is certified by DQS according to ISO 9001:2008.
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Download ISO Certificate (English)
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ISO-Zertifikat herunterladen (Deutsch)
Quality Management System
Manufacturing and Process Specifications
- manufacturing documents: product specifications, process specifications, QA procedures, packing and labeling specifications
- master batch records: full description of process and manufacturing steps
- records are retained for the expected life of the devices
- adequate manufacturing equipment for the products and for the volume produced
In-Process Inspection
- continuous improvement of manufacturing processes; written change control
- documentation of process assembly and inspection test results
- promptly identification and segregation of non-conforming material
- established procedures and controls to prevent cross-contamination
Measurement Equipment
- routinely checked, calibrated and inspected specified production instrumentation and QA/ QC equipment
- maintenance documentation
- written documentation of all calibration procedures
- calibration performed by adequately trained personnel
- all program changes in computers are made by designated individuals
Finished Product Inspection and Distribution
- written acceptance and rejection criteria and procedures describing testing, sampling and test methods
- performance of the final inspection and testing under surveillance of Quality Assurance
- final authority of the Quality Control unit to accept or reject finished material
- records and test data are maintained
- all acceptance records are cross checked by a designated individual prior to release
- properly performance of certified analyses according to documented approved test procedures
- designed labeling procedures and operation areas for preventing labeling mix-up
- maintenance of distribution records to allow traceability
Nonconforming Material Control
- procedures do provide for discrepant or nonconforming material – written procedures do exist
- identification, segregation and documentation of defective materials as to inspection status according to written instructions
- reprocessing / disposition, identification and segregation of the products from other products
- issue of corrective action request to suppliers when a quality problem exists
- maintenance of a follow-up system of control and records of corrective action taken
- policies and procedures to notify customers of adulterated or mislabeled products
Environmental Control, Cleaning and Sanitation
- facility provides adequate space to prevent mix-ups and permits material segregation
- orderly cleaning and properly maintenance of work, storage areas and laboratories