Is Product Audit Mandatory as per ISO 13485?

Valli

Involved In Discussions
#1
Dear All,

Is Product Audit Mandatory for 13485:2003 Implementation? If so as per which clause? It is only a good practice or mandatory requirement as per any standard? Are there any recommended frequency or stages these audits to be performed.

Thanks & Regards,
Valli
 
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harry

Super Moderator
#2
Re: Is Product Audit Mandatory as per 13485?

You need to ask yourself only one question - is ISO 13485 a product standard?
 

Valli

Involved In Discussions
#3
Thanks Harry. But I am expecting more straight answer. Please respond if you know,based of your experience.

Thanks,
Valli
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
You need to ask yourself only one question - is ISO 13485 a product standard?
It appears to me the answer is yes.

Wikipedia reference-linkISO_13485

Wikipedia said:
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Other specific differences include:

* the promotion and awareness of regulatory requirements as a management responsibility, will providing resources and during reviews. An example of the market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
* controls in the work environment to ensure product safety
* focus on risk management activities and design transfer activities during product development
* specific requirements for inspection and traceability for implantable devices
* specific requirements for documentation and validation of processes for sterile medical devices
* specific requirements for verification of the effectiveness of corrective and preventive actions

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.
Is Product Audit Mandatory for 13485:2003
I don't have a copy of ISO 13485 to check. Can anyone verify whether or not ISO 13485 contains a Product Audit requirement?
 

harry

Super Moderator
#5
This is how I look at it.

1. ISO 13485 is a 'Quality Management System' Standard for medical devices.
2. It requires you to identify requirements of the product you manufactured imposed by regulatory agencies, usage, customers, etc.
3. If specific product requirements such as flame-proofing is required, you are required to show evidence of compliance - usually in the form of a test certificate.

Product audit is another specialization by itself and not covered by ISO 13485. You only need to be able to identify specific regulatory requirements related to the product and show evidence that it had been met.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
OK - So the bottom line is ISO 13485 does not specifically require Product Audit.
 

somashekar

Staff member
Super Moderator
#7
7.5.1 : control of production and service provision
8.2.4 : Monitoring and measurement of product
are typically two main ISO 13485 clauses which when audited will look into a product. More over, if the products bear any safety markings, then audits on the product and the testing becomes mandatory to keep and use the safety mark on the product. How your established process and system are working will be evident by auditing a product in manufacturing. I hope this gives you some insight. I would like to understand better from you what you mean by Product Audit.
 

harry

Super Moderator
#8
OK - So the bottom line is ISO 13485 does not specifically require Product Audit.
I don't think this term exist in ISO 13485. Apart from the few differences identified in the wiki page from your previous post, the rest should be similar to ISO 9001.
 
M

MIREGMGR

#10
Why would a company want to implement ISO 13485 other than to improve its products/services/other deliverables, and/or assure the users of those products that they meet specifications and requirements?

Is this question asked because the asker wants an ISO 13485 certificate for marketing/legal reasons, but wants to avoid increasing his costs by exposing product shortcomings to the glare of the auditing process?

That sounds a lot like the kind of legalistic quality-certification approach that resulted in Chinese companies delivering milk with melamine-powder-enhanced measurable-nitrogen levels.

Who, upon seeing that a company is certificated to ISO 13485, would not assume that its medical device products are part of that supposed conformance?
 
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