ISO 9001 Quality Management System audit 21.01.2020
7.2.2020 - News
Kaptas Oy has been ISO 9001 –certified since year 2015 by Bureau Veritas Certification. Re –audit was held 21.01.2020 and results showed that ISO -9001 Quality Management System is supporting extremely well Kaptas company culture to improve continuously operations in aiming to develop Kaptas –quality in practice.
For us quality is just not a certification diploma on meeting rooms wall. Our way of acting is based on customer benefits and needs. We implement projects by documented and systematic processes. In our actions quality is a natural built-in part in every day working with our collaborators and customers. Not a different process, point outs Kaptas CEO Pertti Tykkyläinen.
Strong validation and GMP skills
Pharmaceutical industry is one of Kaptas Oy’s customer groups and their quality demands are hardest. Our actions are based on GMP (Good Manufacturing Practice) –spirit and we are truly proud of our validation experience of which we have experience since 1990’s, tells Project Manager Risto Puhakka.
Validation ensures that equipment delivered by Kaptas maintains the desired level of compliance at all stages. User Requirement Specification (URS) is reviewed together with customer. At the same time the methods to verificate quality during the process are decided. Risk analysis (FMEA/Failure Mode and Effect Analysis) is defined in early phase of validation and it is updated during the whole process. Risk analysis follows the equipment to the end of the life cycle.
Main steps of validation DQ, IQ, OQ and CSV
Main phases of validation are Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Control System Verification (CSV). These phases include several protocols / test documents which defines and verifies the function of the equipment. Documentation and verifying taken actions is essential. Trial runs (PAT, FAT, SAT) are done both in Kaptas and in customer premises.
In addition EU directives has to be taken consideration in manufacturing and has to be documented appropriately. ISO 9001 – Management system is a frame for Kaptas quality work.