Many companies find themselves needing to comply with multiple/sequential standards, for instance, ISO 9001 and ISO 13485 for the medical device manufacturer, and ISO 9000 and AS 9100 or TS 16949 for aerospace or automotive manufacturers respectively. As ISO 13485, AS 9100 and TS 16949 are quality management system standards and are all based upon ISO 9000, it is often considered a valid approach to achieve ISO 9000 compliance first and then upgrade the system to be compliant to the other, additional standard at a later date. While this sounds like a sensible stepping stone for a multiple stage system, there are often reasons why this does not make sense. The additional requirements placed on suppliers by these other standards are often the same things that customers are interested and asking for.  It is in this area that customers are going to show greater interest. What's more, the organization is often complying with the customers requirements anyway and may be closer to compliance than they thought. Then there are the problems and costs associated with splitting the project into two or more stages that will add complexity and delays completing the total project. In most cases it simply does not make sense to put off compliance with the ultimate goal. If a customer is going to “demand” compliance with the more complex standard within a couple of years it probably makes sense to address that standard immediately.

Another common situation occurs when companies are required to comply with the requirements of different customers and/or regulatory agencies. One frequent example would be a company who sells medical devices to the US and to Europe and thus needs to comply with the differing requirements of the Medical Device Directive (MDD) and FDA QSR. The important issue here is to ensure that only one system is developed. The system will encompass the requirements of both regulations and a single system is implemented to satisfy the combined requirements. It may be necessary to implement case-specific activities or generate case-specific documentation, but typically these are minimal.

Another situation exists when an organization wants to address quality management requirements with a standard such as one of those mentioned above, combined with a management system for another functional area such as environmental management (ISO 14001), health and safety management (OHSAS 18001) or information security management (ISO 27001). In some instances the need to address these standards occurs at the same time – from nothing. In other instances, ISO 9001 has been in place for a while and the need arises to add another standard.

Where the standards originate from ISO and are aligned with ISO 9001, there is substantial overlap of some of the requirements and thus implementing two of these standards takes about 75% of the effort to implement the two separately. Even where the standards are not aligned e.g. FDA QSR is not aligned with ISO 9001, a single system needs to be developed. One organization. One way of operating it.

Cavendish Scott advocates the combination of management-system requirements into a single system to comply with as many regulations, standards, and requirements as needed. This ensures a consistent approach that is easy to learn and understand by staff and minimizes project and maintenance costs.