Common ISO 13485 questions
What is the deadline for transitioning to ISO 13485:2016?
Notified Bodies will not issue ISO 13485:2003 certificates after March 2018. Therefore, companies that obtain ISO 13485:2003 by January 1, 2017, for example, will only have a valid certificate until March 2019. After this date, companies must obtain certification to ISO 13485:2016.
When should we start the transition to ISO 13485:2016?
As soon as possible. Notified Bodies will be in high demand as the deadline gets closer due to an industry surge of audit requests. Also, European regulators will pressure Notified Bodies to perform stricter (more time-consuming) audits that exhibit control of manufacturers' suppliers and processes. Also, the number of Notified Bodies available for audits will get smaller as new requirements force some to close their doors. If you delay the audit process, you may find yourself at the end of a very long line.
How long does it take to complete an ISO 13485 audit?
The time needed to complete the audit varies based on the size and complexity of your organization. Emergo suggests that companies allow at least 3 ½ days to complete the inspection process, with up two days spent on-site.
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