Hi...I am just trying to develop an approved suppliers list for our company...proving fairly difficult as we have close to 100 suppliers so trying to work out which effect quality of product etc...
Anyhow just wanted to know is it enough for company to say it has ISO 9001 on its website or do we need a copy of their certificate?

I would say that you need 'objective evidence' that they have ISO 9001 - if that is the criteria you are using. Just because they put on their website or advert in the 'yellow pages' does not tell you a great deal/

e.g. is it done by an accredited body; is it still in date; what is their scope; etc.

Now, if they post a copy of their certificate on the website I would be OK with that.

Hi...I am just trying to develop an approved suppliers list for our company...proving fairly difficult as we have close to 100 suppliers so trying to work out which effect quality of product etc...
Anyhow just wanted to know is it enough for company to say it has ISO 9001 on its website or do we need a copy of their certificate?

From ISO 9001:2000:

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

There is no requirement for an approved supplier list. It's a good tool, but not required.

Out of the 100 suppliers you've mentioned, which ones really have an effect on the product/service you provide to your Customer? Start there.

Narrow the list.

Establish evaluation criteria. (ISO 9001 or other standard certification may be used for that purpose.) But even an ISO certified supplier can cause problems, so do not use that as a sole criterion.

There are quite a few threads and posts here at The Cove Forums about suppliers and supplier selection, so you may want to do a search and read what others have recommended.

Please do come back if you have more questions.

Stijloor.

Also, the requirement for your suppliers to be ISO registered, is your requirement. There is no place in the 9001 standard that says your suppliers must be registered. So, if it is your requirement, do whatever works for you.

Also, the requirement for your suppliers to be ISO registered, is your requirement. There is no place in the 9001 standard that says your suppliers must be registered. So, if it is your requirement, do whatever works for you.


Steel,

Excellent point! :agree1:

Stijloor.

However, if the OP's company is TS, there is a requirement:

7.4.1.2 Supplier quality management system development

The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is the first step in achieving this goal.

NOTE The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied.

Unless otherwise specified by the customer, suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited third-party certification body.

I know this is the 9001 thread, but he didn't state what his own company's status was.

Also, the requirement for your suppliers to be ISO registered, is your requirement. There is no place in the 9001 standard that says your suppliers must be registered. So, if it is your requirement, do whatever works for you.

This is true for ISO9001 standard but if you are AS9100 certified you must maintain a register of approved suppliers and scope of their approval as per 7.4.1a.

Also, the requirement for your suppliers to be ISO registered, is your requirement. There is no place in the 9001 standard that says your suppliers must be registered. So, if it is your requirement, do whatever works for you.
But in some countries we are not so lucky:
some CB has received from national comitee to require it:whip:

I've attached a sample of a simple MS access I designed easy to maintain and if its done correctly the Puchasing agent and Incoming Inspector can view it for Rational for Acceptance and Quality Requirements. It's been reviewed by ISO and FDA auditors and been in use for over five years.

Regards: Richard

Start with your major suppliers

Brake it down type of supplier example:TypeTypeMajor SupplierNo Longer UsedOff-The-ShelfStandard

what are the attached Quality requiremets going to be

Quality RequrementsQuality RequirementsBest Industrial PracticeCertificate of CalibrationCertificate of Conformance/Compliance.Date Code/Shelf Life Supporting Data SheetsFinal Dimensional Inspection ReportFinal Functional Test ReportFinal Visual Inspection Report,ISO 9001:2000ISO ISO 13485:2003Material Safety Data SheetsMaterial Traceability Data Test Certificates (Mill Test Reports)NANo Supporting Documentation RequiredNone RequiredPlating, Painting, or Product Finish Certificates

What style of QMS do they have

Quality SystemQualtiy SystemBest IndustrialISO 9001 2000None

And finally What type of product will they be supplying

ProductProductAcquisition standActuatorAluminum FabricationBeddingBrushCalibrationCarbon Fiber FabricationCasters and WheelsCell Phone + AccessoriesCertification TestingCollimator CoresComputer HardwareComputer SoftwareConductive Rubber Switches and KeypadsConsultingCrystalsElectronic ComponentsElectronic EquipmentElectronic Sub-AssemblyEMC ShieldingEngineering SupportExtrusionsFastenersGasket FabricationLab EquipmentLabel FabricationMachiningMagnetic Foil ShieldMechanical HardwareMedical Supplies and AccessoriesMembrane Switch AssembliesMetal FabricationNuclear Medicine Supplies and AccessoriesOffice FurnitureOffice SuppliesPacking MaterialPaintingPCB AssemblyPCB FabricationPhotomultiplier TubesPlastic ComponentsPlastic FabricationPlatingProduction EquipmentRaw Material HandbooksRaw Material MetalRaw Material PlasticSafety ProductsSafety Sensing SwitchSheet metal FabricationSignsSilicone Optical CompoundSoftwareSpatial Resolution PhantomSpringsTest EquipmentTest FixturesToolsTransportationWiring

I have a general question related to documenting the approval of a supplier. I work in a Spec Dev / Contract Manu company. In this case, it is a prototype supplier that our Customer wishes to use for a limited production run (1000 units) of disposal components for use with a Class II therapeutic medical device. This product will be distributed in the EU. We have not designed nor will manufacturer the entire device... just the disposable assembly.

We have used a prototype supplier in the past for use in a finished product (again, at the request of the customer) for a mechanical Class II handheld diagnostic device. However, the components were non critical and it was for a very limited production run (100 units) for a country that does not require any registration for medical devices.

Has anyone used a prototype supplier for use in production of finished product? Is so, what is the best way to document the limited approval for use of this supplier for a specific customer? This is not a trend I would like to continue. I am also evaluating business risk/costs/yield issues separately. Right now I am concerned with ensuring compliance to the GMPs.

This is my first time posting! I have been a lurker for quite a while and really appreciate the wealth of information and advice this forum provides.

-Lori

Do you need to distinguish them as a proto type supplier? Could you classify them as a small run job shop instead?

As for approveing them, I would use same requirements you use for other vendors. Size of the production run really has no bearing on the approval process, especially if it is a critical component of the final product.

You could approve a vendor to a product run, or you could approve them to a production process. After all ISO is really only a systematic approach to your processes. Just because a company is ISO Certified doesn't mean they make the best product. It simply means they have processes in place to improve the products they do make. Even if the vendor is approved, you still need to provide them with the specs of the job and your quality requirements/tolerances. Same holds true if the vendor is not ISO Certified, you still need to provide them with the job specs, including your quality requirements/tolerances.


No doubt you have crossed this bridge already. How did it turn out? What did you do?