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
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
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.
 
Thread starter Similar threads Forum Replies Date
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 6
I ISO 13485 - Would it be beneficial to get certified under my circumstances? ISO 13485:2016 - Medical Device Quality Management Systems 5
K Definition of SAE under MDR EU Medical Device Regulations 3
M Including devices in kits under the IVDR EU Medical Device Regulations 1
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
A % of defects on the whole batch based on result from inspection under AQL Level II Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Still having trouble as to what equipment falls under 8.5.1.1 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
R Revalidation under VDmax25 following material change ISO 13485:2016 - Medical Device Quality Management Systems 2
K Re-packaging under MDR EU Medical Device Regulations 3
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 5
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
F Plastics cans shelf life determination under static load Manufacturing and Related Processes 1
L Classification under MDR EU Medical Device Regulations 1
K Biological indicator system classification under MDR EU Medical Device Regulations 2
K Advertising and promotion of device under investigation China Medical Device Regulations 1
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 2
F Is there such a thing as 'Critical supplier' status under the Dept. of Health (UK)? Medical Device and FDA Regulations and Standards News 2
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
W Issuing reports under ISO 17025:2017 ISO 17025 related Discussions 2
JoCam Software Translation under MDR requirements EU Medical Device Regulations 6
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1

Similar threads

Top Bottom