The core principles of ISO 15378 are:
- staff (organizational structure, training, hygiene and health);
- the management, cleaning and maintenance of the rooms and of the equipments;
- the acquisition and the control of the raw materials and of the materials of packaging;
- the realization, the packaging and the release of the product;
- the qualification and control of subcontractors;
- non-conforming product management, product rework and recall;
- deviation management and 'change control';
- improvement plans based on data analysis regarding deviations and complaints;
- the documentation (procedures / operating instructions / records) needed for proper operation management.
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The Certification Process
The main stages of the certification iter include:
- Preliminary Verification, performed on request only, allows to evaluate the status of the business management system in relation to what is required by ISO 15378. The gap analysis and gap analysis areas are identified;
- the compliance auditing audit, with the objective of assessing the compliance of the management system with the requirements of ISO 15378, by document analysis and field observations;
- the issuance of the attestation of conformity;
- annual auditing audits and three-year renewal.
For companies already certified under ISO 9001 with Certiquality, compliance verification and subsequent periodic audits can be carried out in conjunction with planned activities such as surveillance and renewals.