Business organizations may have the option of self-declaring conformity to ISO standards and regulations. This is usually a suitable option for organizations that typically have higher standards quality to begin with. The official act of self-declaration has the advantage of avoiding third-party assessment costs which are part of the general conformity assessment procedure. The self-declaration also serves as a commitment to maintaining these standards of quality and procedure. The declaring organization should also be able to demonstrate in good faith that they are capable of consistently meeting ISO standards and regulations without fail. Those that do qualify for self-declaration are still subject to any form of post-market surveillance to ensure their compliance to ISO regulations.
Thus, not every business is recommended to self-declare. Business organizations that do self-declare are also not guaranteed to meet the necessary criteria that will have them exempt from assessment costs. Most notably, companies must provide supporting documentation to establish a historical pattern of meeting if not exceeding ISO standards. If the documentation proves without a doubt that the organization is operating at a high level of quality, they may be able to acquire ISO certification at minimal expense. The organization must also commit to maintaining these standards and regulations. Post-market surveillance will continue to monitor this organization to ensure that they maintain this compliance.
In the end, a supplier’s declaration of conformity may be a great option for organizations that have a previously established standard of excellence. However, many businesses will be forced to seek ISO certification by means of a third-party assessment. The process of self-declaraction does require substantial documentation that would make a reasonable case on behalf of the self-declaring business. Additionally, self-declaration must be marked by a commitment to ISO standards and regulations. After obtaining certification, the business must work hard to keep it. This process will likely also include some form of surveillance to maintain that the organization continues to comply with ISO standards and practices.
