What is the difference between being ISO 9001:2008 registered versus compliant?
The difference can be summed up quite simply. REGISTRATION: Obtaining ISO registration involves an enormous amount of time, up to two years to complete the process, not to mention having a robust infrastructure, a documented Quality system and an on-going commitment by senior management to put in place continuous improvement plans. Then theres the on-going costs associated with the initial assessment audit plus the on-going triennial audits. Registration signifies an unending commitment to quality. COMPLIANCE: Just as the name implies, compliance means to demonstrate an adherence to regulations or policies. Companies that say they are ISO 9001 compliant, have not gone through any formal auditing processes by an accreditation body to document that they have systems and procedures in place. In other words, they simply say they are compliant without any documented proof that they understand the complexities to meet the rigorous standards of the FDA. Driven by regulatory requirements, Inte
