ISO 9001 sets basic standards for what is actually a certified business system. Generally one can say that worldwide, your customers acknowledge and understand the value of a solidly developed quality / business system supporting their supply chain.
This system provides for the existence and control of some very core processes which every business should have. In the case of an ISO certified business those processes are documented, followed by trained staff, controlled and updated as appropriate, and done in a repeatable fashion to assure a consistent output.
ISO generally guarantees more frequent review of process and operational or product discrepancies, those things that might cause customer dissatisfaction or escalate costs. Such review provides earlier or improved visibility into improvement opportunities, ensuring that the appropriate attention and resources are applied in a more timely fashion than might happen in many businesses that haven't been certified.
In some industries, ISO certification is essentially a barrier to entry if it is not obtained. Medical is a good example, in most cases requiring ISO 13485 (the equivalent of ISO 9001 for medical device manufacturing). ISO 9001 is also often required for doing business with companies located overseas, particularly in Europe.
In other cases, a company finds itself in a position where costs swing out of control due to operational, production or process control instability. The effect on the customer base with respect to trusting you as a reliable supplier and the internal cost of managing the defect situation are both painful and eventually result in lost customers.
Engineering efforts, manufacturability, and out-of-the-box profitability become more predictable and more capable of meeting time to market expectations when ISO certified business processes provide for a basic set of interface and review procedures across the organization. It has nothing to do with telling R&D how to do their job or engineering how to develop the product. It has much to do with assuring a process for requirements definition and review, phase reviews, documentation and sufficient cross-functional engagement for manufacturing transfer and release.
The ISO decision is sometimes accompanied by competitive forces, a major production failure or customer loss. ISO has also been used to facilitate competitive differentiation, free up time for innovation by removing barriers, shorten cycle times and reduce the unplanned engineering and operations resource consumption that occurs from variation in output quality.
Generally the executive team will be in agreement or perhaps simply be willing to investigate the benefits of a more developed business / quality system. But in all cases, securing executive support for the effort is a critical starting point.
In many cases there is disagreement as to the need to do anything further to enhance business processes and output. Some people resist change in general, particularly new controls. They view it as "more work" instead of an investment in reducing wasted effort. Furthermore, not everyone subscribes to the theory of minimizing variation to improve profits and customer satisfaction.
While the drivers in each business may be slightly different, we recommend senior management rally behind the need to pursue ISO certification by tying it to part of your company's strategy and encouraging involvement. Cross-departmental barriers should be weakened, staff educated and goals shared. Ultimately, the team's effort will produce data that reinforces the ISO decision. But until then, management should continue emphasizing the benefits of tighter quality, such as:
People need to be rewarded for productivity, meeting development and production schedules, and maintaining consistently high customer satisfaction ratings. Properly recognizing somebody's contribution, however, is challenging. Those employees who have built a well deserved reputation around firefighting the difficult problems that arise have indeed played a valuable role, but management should encourage them to adopt a "preventive approach" versus "reactive".