Q: Does a company certified to ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements that produces raw materials for a customer according to their written specification also, as a raw material supplier, have a responsibility under ISO 9001 to meet the customer’s needs for their design intent and intended and known use?
In simple language, I sell a raw material to a customer who takes my raw material and then designs a product and sells it to a customer who uses it in the field. I wonder where does the ISO standard application stop for the raw material supplier? How can a raw material supplier under ISO 9001 meet the needs of a customer’s trade secret designs, or further down the intended use of the product where the raw material supplier has no control over how it will be used or maintained?
A: Your question is more a legal one than a quality one. You are offering a product to a customer. This is your finished product and their raw material. When both parties agree to the terms and conditions (payment, form, fit, function, shipping, etc.) a contract exists. We call this a purchase order (PO) and part of that PO is the specification for your product. If they place an order to your spec, you have done the design work under ISO 9001 and they are accepting your design. END OF YOUR RESPONSIBILITY for future application and use. If you accept an order to their spec, they have done the design work and you are obligated to make sure your product meets the stated (and often implied) form/fit/function requirements. We call this quality control and you do this by testing in the lab prior to shipment.
Most firms address the issue of application by stating quite clearly in the contract terms that you are selling your product as-is and you do not warrant the product as fit for ultimate use. This is the kind of thing the lawyers require.
Having said all this, there is a requirement in ISO 9001 for you to measure customer satisfaction. You must state in your manual the concept (strategies) for doing this and have some defined processes – usually called procedures – to carry it out. Of course, part of this is the regular management review. Quality, marketing, and sales all provide input on how well the customer needs are being met. Your registrar should be examining how you do this.
If there is a trend showing that customers are unhappy with how the stuff performs under end-use conditions, ISO says you should address those issues. (Ignoring them is an option, if it is deliberate). Mature firms will work on building customer-supplier partnerships, getting their engineers to talk to your engineers. Although this is technically outside of the quality function, it is still part of your overall quality management system.
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author
Open access resources about supplier quality and product development:
Two Sides of the Same Coin: Using Teams in Customer-Supplier Relationships, Journal for Quality and Participation
The Role of Quality Management Practice in the Performance of Integrated Supply Chains, Quality Management Journal
Has Information About Quality Become a Liability? Quality Progress
Product Liability: Beyond Loss Control — An Argument for Quality Assurance, Quality Management Journal