Under what circumstances will a Registrar Audit a Company? (ISO 13485 - Canada)

V

venezia

#1
No sure if the thread falls under this sub or ISO13485.

Under what circumstances will registrar audit a company? I know audit will happen when:
1. Change of location
2. Change of manufacturing process


When we first apply for ISO 13485, design control was not required for Health Canada. Anyone know if an audit will happen for changing design and intended use?

Many thanks in advance! :D :D
 
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Sidney Vianna

Post Responsibly
Leader
Admin
#2
According to the IAF Mandatory Document # 9, the following scenarios would justify/require a short-notice audit:

Short notice audits may be required when:
a) external factors apply such as:
i) available post-market surveillance data known to the CAB on the subject devices indicate a possible significant deficiency in the quality management system
ii) significant safety related information becoming known to the CAB​
b) significant changes occur which have been submitted as required by the regulations or become known to the CAB, and which could affect the decision on the client's state of compliance with the regulatory requirements

The following are examples of such changes which could be significant and relevant to the CAB when considering that a special audit is required, although none of these changes should automatically trigger a special audit:
i) QMS – impact and changes:
▪ New ownership
▪ Extension to manufacturing and/or design control
▪ New facility, site change
* Modification of the site operation involved in the manufacturing activity (e.g. relocation of the manufacturing operation to a new site or centralizing the design and/or development functions for several manufacturing sites) ▪ New processes, process changes
* Significant modifications to special processes (e.g. change in production from sterilization through a supplier to an on site facility or a change in the method of sterilization)
▪ QM management, personnel
* Modifications to the defined authority of the management representative that impact
・ quality management system effectiveness or regulatory compliance
・ the capability and authority to assure that only safe and effective medical
devices are released​
ii) Product related changes:
▪ New products, categories
▪ Addition of a new device category to the manufacturing scope within the quality management system (e.g. addition of sterile single use dialysis sets to an existing scope limited to haemodialysis equipment, or the addition of magnetic resonance imaging to an existing scope limited to ultrasound equipment)​
iii)QMS & Product related changes:
▪ Changes in standards, regulations
▪ Post market surveillance, vigilance​
An unannounced or short-notice audit may also be necessary if the CAB has justifiable concerns about implementation of corrective actions or compliance with standard and regulatory requirements.
 

DannyK

Trusted Information Resource
#3
To get an accurate answer, please speak to your certification body.
When design is no longer an exclusion, this is considered a significant change.
Your contract with the CB specifies that you have to inform them of significant changes.
Also if you have a license with Health Canada, there is a requirement to inform them of this change.
If you do not inform them, a major NC can be issued and your certificate can be suspended.
 
V

venezia

#5
To get an accurate answer, please speak to your certification body.
When design is no longer an exclusion, this is considered a significant change.
Your contract with the CB specifies that you have to inform them of significant changes.
Also if you have a license with Health Canada, there is a requirement to inform them of this change.
If you do not inform them, a major NC can be issued and your certificate can be suspended.


Hi Danny,

Yes, we are definitely going to that. It's just we would like to be prepared if the change will result in an audit.
 

DannyK

Trusted Information Resource
#6
Based on my experience with several CBs, they will definitely want to schedule a special visit to audit the changes.
Get prepared.
 
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