Understanding structure terminology and concept of ISO 9001:2015
Pretesh Biswas
The most significant change we will see in ISO 9001:2015 is the new structure. The reason for the change is to adopt the common approach outlined in Annex SL, the new document that all ISO management system standards, including ISO 9001, ISO 14001 and the recently released ISO 27001, must follow. Currently, ISO 9001 contains 8 sections, of which four attempt to approximate “plan, do, check, act.” The new structure, based on Annex SL, has 10 sections four of which also approximate to “plan, do, check, act.” All new management system standards will have this common structure. Here is the new structure:
- Scope
This section describes the scope of the management system standard and will be unique to the individual standard. - Normative References
This section references other relevant standards, which are indispensable for the application of the document and will also be unique. - Terms and Definitions
Section three contains definitions, and while some of these are common terms related to Annex SL, other definitions will be unique to the management system standard. - Context of the Organization
This part is about understanding the organization’s purpose, the management system and who the stakeholders are. It describes how to set up the management system and is similar in some respects to the old section 4 except that it explicitly requires a broader understanding of the situation and needs of the business.
- Leadership
This section provides requirements for commitment, policy and responsibilities. This section is similar to the old section 5 on Management but the emphasis is perhaps more on leadership than just management. This is a “soft” requirement and it will be interesting to see how it develops.
- Planning
Planning is now a section on its own. Planning was always covered by the current standard in sections 4.1, 6.1, 7.1 and 8.1 but the new structure includes risk (which is now a clear requirement) and opportunities, the setting of goals and objectives to achieve plans, and resources. Interestingly, risk was introduced in AS9100 (the aerospace version of ISO 9001) in a similarly limited manner. In the latest version of AS9100, however, risk was expanded and defines a number of specific requirements/activities for a risk process. It will be interesting to see whether ISO will leave the requirement for risk as a general requirement as defined in Annex SL or whether it will take AS’s lead and expand it. This planning section also requires a greater application of goals and objectives to integrate with the management system’s planning and operation to generally facilitate success of the organization.
- Support
The support section includes most of the expected support processes that exist in an organization and which are covered in the current ISO standard. Human resources is renamed as “competence”, and communication, which will require a new approach in most organizations, is given its own section rather than a mention as a management responsibility. Finally, document control has been renamed “documented information.” It now covers both procedure/document control and records control.
- Operation
This is a relatively short section, which essentially says “Do a good job” at whatever your management system is trying for. In the case of ISO 9001, that is quality and in the early drafts we have seen of ISO 9001, significant familiar content is added here including design, customers, purchasing and production/service (although many of the sections have new titles).
- Performance Evaluation
The section on evaluation includes monitoring, measurement and analysis, internal audits and management review. All familiar topics with some subtle changes. - Improvement
Improvement covers nonconformity and corrective action, as well as continual improvement, all of which are outlined in section 8 of the current standard. There is no preventive action section any more as effectively it is replaced by “risk” under planning – improvement is now defined as a proactive planning activity.