ISO 9001

¶ … firms have been outsourcing the manufacturing of numerous products. In the case of So Safe Advanced Hospital Products (SAHCP), the company has been using this to produce an insulin delivery system. That is built in Brazil and Mexico. These practices have created concerns about quality control procedures. To fully understand what is happening requires examining the problem, how SAHCP should respond, if the firm is ISO compliant and internal recommendations for upper management. Together, these elements will highlight the best strategy for the company.

(Abuhav, 2012) (Doyle, 2009) What is the problem from the perspective of a business decision and quality function? Please support your explanation with facts from the case. The problem is that quality control managers are not effectively doing their jobs in monitoring for any kind of manufacturing defects. At the same time, they are not analyzing the design of the insulin pump and possible areas where there could be flaws.

Inside the case, these different issues were reported with some of the most common complaints to include: The tubing is stained When the system is restarted, it does not flow easily Sometimes it is extremely difficult to connect the syringe to the pump These various criticisms are showing how the primary issues are from the design and quality control of the final product.

(Abuhav, 2012) (Doyle, 2009) Does the fact that this company states ISO compliance and has 'never had a bad product' influence how SAHCP should respond to these issues? The fact that the firm new had no bad products should not influence their reaction, but it does. This is because executives have become somewhat delusional from these types statements. These views are problematic, as the company will miss critical issues in the manufacturing and design process.

As a result, the firm needs to concentrate on delivering a safe, quality and reliable product to consumers. This will require transforming the way it responds to numerous challenges. (Abuhav, 2012) (Doyle, 2009) Based on the facts of this case, is SAHCP ISO compliant? Please provide specific examples from the case to support your comments. SAHCP is not ISO compliant. A good example can be seen with the firm's response to the most common complaints.

They claimed that the discolored tubing was cosmetic and how the staff must be trained properly prior to / during operation. None of these issues were directly related to something they did. Instead, it was the customer overreacting to nonexistent issues or errors when using the machine. These kinds of statements are showing how management is refusing to investigate these cases further. This is troubling, as it does not address specific problems with the product.

Under ISO regulations, the company has an obligation to provide customers with a product that is safe and reliable. In the event there are defects, the manufacturer is expected to investigate and resolve these issues. The way the firm is reacting, is clearly a sign of how executives are ignoring key problems. (Abuhav, 2012) (Doyle, 2009) As the Quality Manger, what 'internal recommendations' would you make to SAHCP management? Why? The different internal recommendations include: becoming more customer focused.

This requires providing them with a product that is safe, high quality and has outstanding support for defects. One possible avenue is to have managers impose strict safety monitoring procedures at all manufacturing facilities. This will ensure that ISO standards are met before the device leaves the location. (Abuhav, 2012) (Doyle, 2009) In countries where the product is sold to cliental, the firm needs to open customer service centers. This is when they can discuss their complaints about the product and receive assistance with the machine.

In the future, this will show consumers how the company understands their problems and is doing their best to address the.