We have long understood that to be one of the most successful companies for developing challenging, technology-based products (especially in the medical industry), we had to create and implement well defined design processes and efficient design strategies. Without robust design processes, it is all too easy to lose track of critical design issues – the consequence of which is usually schedule delays, added costs, and/or undesirable design compromises.
Therefore, following extensive research and planning, we decided to utilize ISO standards, which are recognized worldwide, as the basis for defining our design processes. With a sturdy foundation, we were able to then tailor the system to our needs as a design firm, adding the necessary design strategies that would enable us to confidently provide our clients with the highest quality and most cost effective solution to their product development needs.
Since 2003, we’ve had a certified quality assurance program that not only satisfies the requirements of ISO 9001 and ISO 13485 but also enables us to efficiently design technically challenging products in accordance with many of today’s stringent design and regulatory requirements. In other words, our quality assurance program, combined with our design and development procedures, enable us to quickly and cost effectively develop everything from simple mechanical parts to complex, automated, medical devices that require extensive regulatory compliance. In addition, at the end of a project, we will have confidence that:
- we haven’t overlooked a critical design issue
- the product will be safe and effective for the intended use, and
- all the documentation necessary to verify and validate the effectiveness of the product design will be available to satisfy regulatory requirements or to transfer to our client for their documentation needs.
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Why We Implemented ISO Quality Management System: We were a start Cable Television Network. Start-Up organizations generally operate in a performance paradox where things that are important to ‘reducing the effort needed to succeed’ (Efficiency) are considered as secondary to things that ‘make it look like success has already arrived’(effectiveness). For example, a Start-up organization would generally not turn down a project that required way more resources than it has; it must take on the project and in so doing over-extend its resources in a way that is not sustainable in the long run. Thus, the quickest way to do something becomes the best way to do it and the organization’s operating system quickly begins to resemble ‘a tyranny, where the urgent rules over the important’. Simply put, our innovation seeks to reduce the cost of this tyranny; it seeks to change our operating culture.
In four (4) months, we went from having no formal business processes to having over 4000 business processes, procedures, records and documents located in one centrally accessible storage area that taken together formed the official repository of how RLTV operates.
We did this by developing and implementing a Quality Management System (QMS) designed to meet or exceed ISO 9000 requirements. We began active implementation of the QMS in August 2007 and achieved ISO certification in December 2007. However, attaining certification was our minimum requirement. The real goal is to change our operating culture by augmenting the ‘just get it done’ start-up energy with a more deliberate ‘planning and execution’ based culture by incorporating the ISO 9000 Quality Assurance methodology of:
Plan: establish the objectives and processes necessary to deliver results
Do/Execute: implement the processes
Check/Assess: monitor and measure processes and products/services against objectives
Act/Adjust: take actions to continually improve process performance