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

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

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

Thanks,
Valli

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

It appears to me the answer is yes.

ISO_13485

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?

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.

OK - So the bottom line is ISO 13485 does not specifically require Product Audit.

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.

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.

Agree with Harry and Somashekhar :agree1:

Valli, can you be more specific ?

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?

I would say this is not required for 13485 but if you have a CE Marked Product it would be required as part of this process. Again this depends upon the classification of the device.

The standard does require you to either validate the production, etc process but only if your QC methods do not determine whether the device actually performs to specifications.

Hope this helps!

JCVP

There is no "product audit" requirement within 13485. There is only a requirement to audit the quality system. If you want to incorporate a product audit as part of the quality audit, there's no reason why you can't.:D

Dear All,

Thanks for your response. Let me clarify the objective of starting this discussion.

I am new to this 13485 process and see very limited awarness among the people I know. From this forum I am seeking guidance this process.

1. As a first step we Want to comply to the stated requirement as per 13485 standard.So want address mandatory requirements. Hence the question is Product Audit Mandatory. Looks for the discussion so far it is not mandatory.

2. As second step want to address improvement or good practice. Looks it is good practice. If so , are there any guidelines or standards or more details about Product Audit Process.

3. We are going for MDD /CE certification process also. We are manufacturing Medical Equipements from India. Can any recommeded some good EARs service provides. Has anyone taken service from Obelis , MDSS or Wellkang.

Regards
Valli

Dear All,

Thanks for your response. Let me clarify the objective of starting this discussion.

I am new to this 13485 process and see very limited awarness among the people I know. From this forum I am seeking guidance this process.

1. As a first step we Want to comply to the stated requirement as per 13485 standard.So want address mandatory requirements. Hence the question is Product Audit Mandatory. Looks for the discussion so far it is not mandatory.

2. As second step want to address improvement or good practice. Looks it is good practice. If so , are there any guidelines or standards or more details about Product Audit Process.

3. We are going for MDD /CE certification process also. We are manufacturing Medical Equipements from India. Can any recommeded some good EARs service provides. Has anyone taken service from Obelis , MDSS or Wellkang.

Regards
Valli
MDSS. I have found them good for my requirement.

Some information regarding the term "Product Audits" as indicated in the ASQ-CQA training module:

A Quality audit can focus on a Product, a Process, or a System.
Product audit is an in-depth examination to determine the conformity of a product with any of the following:

-Product specifications
-performance standards
-customer requirements

Some examples of product audit include: examining the packaging, evaluate the apprearance, verify approprate documentation(labels, IFU), and identify if applicable accessories are included in final shipment.

Product audits are not inspections because product audits are conducted after final inspection and serves to reinspect or retest of a product that has already been inspected.

When I perform internal audits(to meet ISO13485 and MDD), I may also include a product audit as part of a process audit, based on my defined audit scope.

Hope that helps.

Hi cclee,

Thanks for the valuable info - Great post indeed :agree1:

Hope to see more from you :)

Any more feedback of EARs Please.


Regards,
Valli

ISO 13485 places an emphasis on validation. If you can identify the key CTQ characteristics in terms of raw materials and process (equipment parameters), then the key inputs to the product /process will be (hopefully) in control.

You can use this approach to demonstrate a degree of control, and if the inputs are in control - then the resultant output(s) should be predictable.

I would still like to see the sanity check on some frequency to perform an actual product audit to check that the system does in fact deliver the expected results - frequency of this activity would need to be an assessment of how confident you are.

In my opinion there is no ISO 13485 section that requires a product audit. My company though goes above and beyond and pulls a sample out of finished goods inventory and opens it just like we are the customer. The audit team has representatives from departments like Marketing, Quality, Design, Manufacturing and Regulatory. In looking at the product we ask ourselves the simple question.....Is there anything here that would generate a customer complaint?

:agree:

Hii Valli..

We are looking for Obelis as EAR for our product. Did some ground work and seems to be good.

Thanks,
Sr'nu