Introduzione alla ISO 13485: sistema di gestione della qualità per i dispositivi medici ISO 13485:2016

The PECB ISO 9001 Lead Implementer is a five-day training course that aims to help you develop the competence necessary to establish, implement, operate, maintain, and continually improve a QMS. This training course aims to equip you with in-depth knowledge on ISO 9001 requirements, as well as the best practices and approaches used for the implementation and subsequent maintenance of a QMS.By attending this training course, you can help organizations utilize a structured and evidence-based approach for managing the quality of their products and services. Apart from this, you will also learn about the importance of customer focus and benefits of setting the foundations of an organizational culture which enables and supports quality.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO 9001 Provisional ImplementerPECB Certified ISO 9001 ImplementerPECB Certified ISO 9001 Lead ImplementerPECB Certified ISO 9001 Senior Lead ImplementerEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationPECB will provide over 500 pages of instructional materials containing explanations, guidance, and practical examples.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.PrerequisitesThe main requirements for participating in this training course are a basic knowledge of ISO management system standards, overall knowledge of ISO 9001, and the MS implementation principles. An understanding of ISO’s quality management principles may also facilitate the learning process.Languages available: English, Spanish, French, Russian, Hrvatska (Croatian), German, Ukrainian, JapaneseThe fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included) First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF) (AMF is not applicable for Foundation, Provisional and Transition Certification)

Il corso è volto a fornire gli elementi metodologici per la preparazione e l’esecuzione di audit interni dei Sistemi di Gestione per la Salute e Sicurezza sui luoghi di lavoro.ProgrammaPrimo giorno• Presentazione del corso e dei partecipanti• Introduzione delle norme UNI ISO 19011 e UNI ISO 45001• Competenza, conoscenza e capacità di un auditor• Introduzione al processo di audit• Analisi dei requisiti: pianificazione (Plan)• Gestione dei Programmi di Audit• Pianificazione dell’Audit• Preparazione dell’Audit• Esercitazione 1 - Preparazione del Piano dell’AuditSecondo giorno• Analisi dei requisiti: attuazione (Do)• Esercitazione 2 - Preparazione della check list• Conduzione dell’Audit• Analisi dei requisiti: monitoraggio e misurazione (Check)• Analisi dei requisiti: miglioramento continuo e raggiungimento degli obiettivi (Act)• Conclusione e chiusura dell’Audit• Esercitazione 3 - Conduzione dell’Audit (RolePlaying)• Esame scritto