Global quality management standards had their beginnings in the late 1980s with the publication of the ISO 9000 series of documents developed by ISO/Technical Committee (TC) 176. The intent of these documents was to provide an internationally recognized set of quality management standards for all industries. The ISO 9001/2/4 standards were adopted in Europe as an analogous series of standards, EN 29001/2/3, and subsequently as EN ISO 9001/2/3.
It became clear that at least one specific segment of industry required special consideration regarding quality management standards—the medical device industry. The reason for this unique need stemmed from the fact that manufacturers of medical devices are subject to additional requirements from various national regulatory bodies. In order to produce standards that also met such regulatory requirements, a supplemental set of European quality management standards, EN 46001/2/3 series, could apply directly to the medical device industry in such a way as to comply with regulatory requirements.
The desire to progress from European medical device quality standards to globally recognized standards led to the creation of ISO 13485: 1996 and ISO13488: 1996, which detail requirements for ISO 9002 applications. In the same way their European predecessors referred to EN ISO 9001/2, the ISO 13485/8: 1996 referred directly to provisions in ISO 9001/2 in that they were not stand alone. This was in recognition that the primacy for quality management standards as defined by ISO, rested with TC 176 and the philosophy of TC 176 was not to proliferate quality management standards industry by industry.
ISO 13485/8: 1996 produced a tremendous affect on global harmonization of regulatory requirements. They became the quality management standards for Canada and are available as an alternative set of quality management standards in Australia. They are destined to replace the European standards, EN 46001/2 in 2004, and they are the source of information for revisions to quality regulations in both the United States and Japan. This is due, in no small measure, to the close cooperation that existed from the beginning with the Global Harmonization Task Force that represents countries that are home to the world’s major medical device manufacturers.
Why revise ISO 13485/8: 1996?ISO 13485/8: 1996 incorporates ISO 9001/2: 1994 as normative documents. As such, any changes in ISO 9001/2 automatically would become requirements for ISO 13485/8: 1996. So when TC 176 made significant changes to both the organization and the content of the ISO 9000 series of documents, changes to ISO 13485/8: 1996 became a foregone conclusion.
The changes to the ISO 9000 series of standards affected both structure and content. Three documents, ISO 9001/2/3: 1994 were combined in a single document—ISO 9001: 2000. In place of 20 areas of quality system requirements in the 1994 version, the 2000 version organizes requirements into four process areas. Prior requirements for documentation were reduced significantly to only a few documents and a few documented processes. New requirements for continual improvements to the quality system and for demonstrating customer satisfaction were added.
These changes posed both opportunities and challenges to TC 210 as it approached the revision to ISO 13485/8: 1996. There was the opportunity to reduce the number of documents requiring maintenance by following the TC 176 lead and incorporating ISO 13488 into ISO 13485. But the reorganization of ISO 9001: 2000 into process areas approached required a similar reorganization of ISO 13485. And, since documentation is essential to regulatory bodies, documentation requirements needed to be re-inserted into the revised ISO 13485 in order not to “lower the requirements bar” compared to ISO 9001/2: 1994 and ISO 13485/8: 1996 standards.
Of even greater concern, however, was how to deal with the new requirements that ISO 9001: 2000 introduced in the areas of continual improvement and customer satisfaction. These two items in effect raised the requirement bar with respect to prior standards and regulatory requirements. Putting a device manufacturer’s certification at risk based on an inspector’s perception of whether or not the quality system had, indeed, improved, or that customers were, in fact, satisfied, was not consistent with the realities of a regulated industry where effectiveness and meeting requirements are the norm.
How the new version differsAfter considerable discussions with TC 176, the decision was made to pursue an independent, stand-alone revision of ISO 13485, which will remain as consistent as possible with the provisions of ISO 9001: 2000, but which will depart from ISO 9001: 2000’s wording in those instances as necessary because of existing or emerging regulatory requirements. The organization of ISO 13485: 2003 contributes to the reduction in quality standards documents by absorbing ISO 13488: 1996.
The key areas of concern compared to ISO 9001: 2000 are documentation requirements, continual improvement and customer satisfaction. These concerns are also addressed in the new stand-alone ISO 13485: 2003. All previous levels of documents and documented procedures are retained. The requirement for continual improvement in the quality system is replaced by the requirement for demonstrating the continual effectiveness of the quality system to meet customer requirements. The need to demonstrate customer satisfaction is replaced by the requirement to demonstrate a customer feedback process that provides objective evidence the organization, is, in fact, meeting customer requirements.
There are additional concerns. The changes in ISO 9001: 2000 were also accompanied by a significant change in the nature of ISO 9004: 2000, which before had served as a guidance document for the ISO 9001/2/3 standards. ISO 9004: 2000 is not a guide to the implementation of iso 9001: 2000, but rather acts as guide over a wider range of objectives than is covered in ISO 9001: 2000, particularly with regard to improving the organization’s overall performance and efficiency. In contrast, the intended use of the guidance document for ISO 13485: 2003, to be published as ISO/TS 14969: 2003, has not changed. However, in the interest of a rapid publication, it will be published as a technical specification not a standard.
ISO or QSR?As widespread in acceptance as the ISO 13485/8 document has become, and ISO 13485:2003 is expected to be, the U.S. Federal Drug Administration (FDA) will continue to rely on the Quality System Regulations (QSR) as its standard. The QSR is the FDA’s set of guidelines that U.S. manufacturers must adhere to. The regulations are harmonized with ISO 9001 and ISO 13485: 1996. Individual manufacturers will need to consider carefully whether to achieve certification against ISO 9001: 2000 or ISO 13485: 2003 or both.
Transition to ISO 13485: 2003 will be somewhat complicated because of the December 2003 expiration of ISO 9001/2/3: 1996, which serves as normative documents to the existing ISO 13485/8: 1996.
The combined effects of ISO 9001/2/3 and ISO 13485/8 quality management standards have created a remarkable degree of harmonization with the countries that are home to the majority of medical device manufacturers. This has only been possible because of the close cooperation between the respective ISO Technical Committees (176 and 210) and the Global Harmonization Task Force. ISO 13485/8: 2003 is expected to continue to progress toward global harmonization as it takes effect over the next several years. Q
- Assuring customer satisfaction: This goes beyond the safety and efficiency of medical devices. To a large extent the requirement to assure customer satisfaction is outside the purview of medical device regulators.
- Engaging in continual improvement with regard to increasing efficiency: Improvement is within the medical device regulator’s purview when it is done to correct violations. However, improvement for the sake of operating more efficiently is outside the purview of medical device regulatory agencies.
- Documentation: ISO 9001: 2000 requires less documentation. Auditors and investigators, whether from FDA or from some other organization, need documentation to know what a company intends to do and what they actually did.
Q & A: ISO and QSRWhy did FDA harmonize its regulations with ISO?
- Many other countries rely on ISO standards in regulating medical devices. It is easier and less confusing for industry to develop a quality system if the quality system requirements of various countries are similar.
- FDA and device regulatory agencies from other countries can more readily rely on one another’s inspections and exchange inspection reports if the quality system requirements are similar. This becomes important when countries negotiate agreements to exchange information with one another.
FDA found that ISO 9001 did not totally serve its purposes. Also, ISO 9001 is revised periodically and might serve FDA’s purposes even less after future revisions. ISO 9001 is copyrighted and cannot be published as a Federal Regulation in the Federal Register.
Can’t FDA just change its regulations to harmonize with the new ISO 9001: 2000?
FDA and medical device regulators from other countries see problems with enforcing some ISO 9001: 2000 requirements relating to:
- Assuring customer satisfaction: This goes beyond the safety and efficiency of medical devices. Therefore, to a large extent the requirement to assure customer satisfaction is outside the purview of medical device regulators.
- Engaging in continual improvement (in regard to increasing efficiency): Improvement is within the medical device regulator’s purview when it is done to correct violations. However, improvement for the sake of operating more efficiently is outside the purview of medical device regulatory agencies.
- Documentation: ISO 9001: 2000 requires less documentation. Auditors and investigators, whether from FDA or other organizations, need documentation to know what a company intends to do and what they actually do.
Also, ISO 9001: 2000 is written using a process model approach instead of the twenty (20) element format used in ISO 9001: 1987 and 1994. In a voluntary standards arena there is no requirement for a manufacturer to change the structure of its documentation to meet the format of the standard. In a regulatory environment, however, manufacturers often feel the need to align their documentation structure with that of the regulations.
FDA sees no safety or quality benefit in having the manufacturers completely change their documentation structure and systems to the process model. Manufacturers may choose whatever documentation structure and system works best for their organization and regulatory obligations. The reasons the authors of the new ISO 9001: 2000 changed to a process model are not necessarily transferable to the medical device industry.
Source: U.S. FDA