Certification of conformity to ISO 15378 applies the requirements of ISO 9001 to good manufacturing practice (GMP) in the design, manufacture and control of primary packaging materials for medical and pharmaceutical products (cellulose, polyethylene, glass etc.).
Our service includes verification and validation of the materials manufactured and risk assessment to guarantee the safety of the packaging against any risk of microbiological, chemical and particle contamination and to assure that it functions as desired.
WHY RINA SERVICES?
RINA SERVICES has developed its professionalism in this sector thanks to the elevated competence of its staff, matured through constant investments in training and in the selection of specific resources.
Our extensive experience has allowed us to obtain:
- dual ACCREDIA and ANAB accreditation for the ISO 9001:2008 standard in sector 38 - Health and Social Services;
- numerous certifications, both in Italy and abroad, in hospitals, clinics and nursing homes, laboratories, rehabilitation facilities and social services;
- qualification of audit teams.
The certification procedure involves:
- compilation and dispatch of the questionnaire
- definition of the offer and stipulation of the contract
- optional pre-audit
- initial certification audit and document review
- issue of certificate
- annual surveillance audits
- recertification audits (every 36 months).