The process of receiving an ISO-9001 registration involves the development and implementation of a Quality Management System (QMS) that complies with the requirements set forth in the corresponding ISO-9001 international standard.
Developing a QMS involves taking pre-existing and/or non-existing informal processes and formalizing them by documenting each process with a written standard operating procedure. Additionally records need to be kept in order to provide objective evidence that each process is indeed working and producing subsequent results.
Certification vs. Registration
The technically correct term that should be used is registration. Certification is often used because the process of conforming to the ISO-9001 standard concludes with a “Certificate of Registration.” Henceforth the use of the word “certified.”
Following a successful audit of the QMS, by an appropriately credentialed third party independent auditor, the system is formally “registered” with the governing body that is sanctioned by the global ISO authorities responsible for developing and maintaining the ISO standards.
Challenges
The most significant challenge involves achieving a cultural change within a company. When there are only implied understandings of what to do that constitutes an informal process that is often subject to non-conformance. Convincing employees to embrace a formal process involves change and that takes time. Quite often broad support for these initiatives does not occur until positive results are achieved.
A secondary challenge is sustaining the QMS after the registration has been awarded. It is not unusual to see an organization revert back to “business as usual” following an ISO registration. It takes strong commitment and support from upper management to ensure that the progress made in achieving the initial registration is sustained into the future. To that point ISO-9001 requires companies to periodically perform internal audits of their system and to also bring in an independent third party auditor to verify that system is indeed being maintained.
Market Opportunities
The most significant marketing opportunity occurs when a company publicizes its registration in product catalogs, datasheets and on their web site. The presence of an ISO registration logo and/or statement conveys to potential customers that the company is serious about quality and continually improving its processes. That serves to demonstrate value to the customer who seeks assurance that they will be satisfied with the purchase of the company’s products.