Enews - 24 February 2014
BSI medical device unannounced audits webinar
On 11th February 2014 experts from BSI covered key aspects of the new requirements such as the potential need for new contractual agreements, operating procedures, and preparedness planning among staff.
Other important details include:
- EU Commission Recommendation requirements and how BSI will plan and perform unannounced audits
- Information expected by a Notified Body so that the audit team can audit products and processes relevant to your EC certificates
- Typical audit frequency and duration
- Impact of high risk products and multiple locations
- Areas of R&D, operations, and testing that will be subject to audit
- Types of subcontractors and suppliers that are potential candidates for unannounced audits
To view the slides and hear the recording from this presentation and stay informed on important updates on unannounced audits please visit our website and register*.
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