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ISO 9001 : 2015 Quality management system
ISO standards undergo a review every five years and are updated as necessary to ensure they remain relevant and useful for the industry. The business landscape and challenges faced by organizations today are significantly different from those a few decades ago, and as such, ISO 9001 has been revised to reflect this new environment.
While the old and new standards cover similar topics, there are some significant differences between them. The following paragraphs will discuss some of these differences.
Structure of standard
It is possible to establish a general structure for management system standards because the fundamental concepts such as management, clients, needs, policy, procedure, planning, performance, objectives, control, monitoring, measurement, auditing, decision-making, corrective action, and nonconformity are universal across all these standards. While this can simplify the process of implementing multiple standards for organizations as they will all have the same basic requirements, it may cause some initial disruption as organizations adapt to the new structure.
Information on the required documents
The new ISO 9001:2015 standard has done away with the conventional differentiation between documents and records, and has replaced them with the term “documented information.” It is unclear why ISO chose to discard two well-established concepts and adopt a new, complex one.
ISO’s definition states that documented information refers to information that must be controlled and maintained. Therefore, whenever the new standard uses the term documented information, it implicitly expects the information and its supporting medium to be controlled and maintained. However, this is not the whole story.
According to Annex A of the new standard, the term “documented procedures,” which was used in the previous version (ISO 9001:2008), is now expressed as a need to maintain documented information. Similarly, the term “records” in ISO 9001:2008 is now expressed as a requirement to retain documented information. This means that whenever the new standard refers to documented information and asks for it to be maintained, it is referring to what was previously called procedures, and whenever it asks for documented information to be retained, it is referring to what was previously called records.
Therefore, even though the definition of “documented information” has abandoned the distinction between documents and records, the use of the words “maintain” and “retain,” and the implications of these words (according to Annex A), actually restore this distinction in the main body of the standard. In essence, while documents and records were seemingly removed, they were effectively allowed back in through the back door.
Benefits of ISO 9001 : 2015 Quality management system
The updated version of the standard offers several advantages to its users, including:
- Improved handling of supply chain management
- Clearer language and consistent structure and terminology that can be especially beneficial for organizations using multiple management systems, such as those for environment, health and safety, or business continuity
- Greater focus on leadership involvement
- Structured support for addressing organizational risks and opportunities
- Enhanced user-friendliness for service and knowledge-based organizations