Session 3:

Personal opinion, not IATF opinion: M. Bird questions more and more the validity of 3rd party certification of management system at all, because the companies that do well generally have management system that comply with all the requirements. And the companies that get these certificates because they need them and not necessarily want them do the minimum to get the certificate on the wall. Therefore we always have weaknesses. IATF has agreed to undertake a survey to assess the relation between a management system and the product quality. How much money the sector spends on 3rd party certification each year compared to the value which we get from it (particularly when we get some vehicle manufacturers who even today do not mandate 3rd party certification: their argument would be " why do you have to specify a supplier gets a certificate when there is a contract that request them to provide with good parts anyway?"). It is difficult to put the quality of a product next to the quality of a management system, it is a bit of an unknown, it is an indicator whether there are problems, and when you want to look at cost, certainly in the automotive industry where production is continuous costs can escalate exponentially if a production line stops. Anything that gives us an indication of where there may be a supply problem such as weaknesses in the management system, it is normally worth the investment to avoid that happening, and that is why we still justify carrying on with the management system.

This answer is also applicable to medical devices.

The GHTF does not yet develop technical standards for medical devices. There are many standards already existing and GHTF is happy with that. Nevertheless the problems that the consumers face with medical devices (implants) are special, but the consequences may not be so different than driving a car at 200km/h and your brakes fail. The outcome is the same.

Medical devices with 0 defects is something that the press, the public and sometimes the government asks, but this is impossible. In real life failures may happen. As medical devices are technical devices, they may be difficult to produce and therefore also difficult to use, so in addition to product failures, there is also a broad range for user errors. GHTF would like to have quality standards applied as high as it is required. In real life experience, many defects are reported regarding medical devices (FDA database, Canada database, GHTF database) and then it is absolutely necessary to have a mandatory reporting scheme and mandatory responsibility scheme which ultimately calls on the manufacturer or the importer to be responsible for the product and issue recalls or other corrective actions as needed.

The scheme was developed to support the requirement of the car manufacturer in their quality of customers. There are number of sectors that asked to be considered into the scheme (this has been consistently resisted by the OEM vehicle manufacturers). The standard scope is very clear, it is about manufacturing components for the car industry (cannot be expanded to off road, agricultural vehicles, transport vehicles...). There are many other sector scheme in the world but IATF is actively policing the application of the scheme rules

IATF has developed the training of auditors and continues to develop it. IATF contract with 89 CB's only (out of the 1000+ CB's in the world). There is a requirement for experience, the oversight offices of IATF (5) have their own training body and those alone are allowed to qualify auditors.

They have to be approved by IATF. All the auditors pass the IATF training scheme. A peer review exercise has been done 18 months ago where IATF took somebody who was a past member of IATF and he was hired to do an audit on each of IATF oversight offices including our witness auditors. Because we believe that for a system to be credible, we should be seen as applying our requirement consistently to ourselves. This audit returned some discrepancies but nothing that was not fixable. IATF does not have a particular training for a witness auditor.

CI does not write standards so CI have no standards on this. What CI does is to try to support its members in terms of how they can be involved in market surveillance, and CI recognize that consumers have a critical function in market surveillance because they have the possibility to give feed back to the authorities and they can also contribute in terms of performance assessment (whether the market surveillance scheme which has been put in place is working or not). CI tries to empower its members so that they get effectively engaged in market surveillance, but it has no standard that it can recommend to CASCO. CI would be happy to see a CASCO document of best practices or guidelines that could be commonly used and that would generally facilitate the market surveillance.

The consumers role in market surveillance is to ensure that they inform the relevant authorities when they identify a product or a service that has failures.

The question of counterfeiting has not been addressed by the workshop.