Disclaimer: Christopher Paris, founder and VP Operations of Oxebridge, claims to have access to the committee draft of the new ISO 9001, set to replace ISO 9001:2015. It is to be noted that we do not have access to the committee draft and this blog is based on the findings of Christopher Paris.
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Overview
The new ISO 9001 committee draft is confusing and even though, from a literal sense, there are some changes, from a practical standpoint, the changes are almost negligible. In fact, in some cases, it is going backward and giving organizations relaxation about things, which can be very risky. Let’s get started.
1. Top Management Commitment (Clause 5.1.1 General)
- Promotion of Ethics and Integrity: Requires top management to promote ethics and integrity.
- Mission, Vision, and Values: Management must determine, implement, and improve the organization’s mission, vision, and values, promoting an aligned quality culture.
Our insight
From an ideal world perspective, this concept sounds commendable and fair. However, unless it addresses KPIs related to ethics and integrity, it holds no real value. Top management can present some evidence that they are endorsing this mindset, but there is no risk of them receiving a nonconformity for it.
Isolocity QMS Capabilities:
Organizations can document their mission, vision, and values in Isolocity. Top management can also set objectives and track the KPI’s that allow for quick adjustments. They can also include documents detailing how top management aligns with quality objectives and promotes ethics and integrity. Additionally, we take it a step further by allowing organizations to track employee activities through an audit trail, enabling top management to review actions if issues arise. From a proactive standpoint, top management can ensure all employees undergo ethics and integrity training via the training module and establish specific KPIs for these areas.
As you click on the view diff link, this is what you come across.
Also, here’s another example of the training program module of Isolocity.
2. Addressing Risks and Opportunities (Clause 6.1)
- Distinction Between Risk and Opportunity: This clearly distinguishes between risks and opportunities.
- sub-clause 6.1.1.1 discusses risks
- sub-clause 6.1.1.1 discusses opportunities
Our insight
We believe this change is positive. However, there is a minor issue: they neglected to define opportunities, leaving it somewhat open to interpretation. Additionally, since this is not a requirement, it primarily affects terminology and could even create new possibilities. Given that risks are typically prioritized, if questioned about why a particular risk was not addressed, one might simply respond that it was not a risk but rather an opportunity.
Isolocity QMS Capabilities:
Isolocity QMS offers advanced capabilities in risk management, helping companies stay compliant with PFMEA and HACCP. The PFMEA template is ready for users to fill out, and the system calculates severity, detection, and RPN levels based on the provided inputs. The HACCP process is similarly streamlined, with a pre-built template that users simply need to complete.
Additionally, for opportunities, users can track them through the planning module. This ensures that the entire organization is aligned when it comes to capitalizing on opportunities. Our quality planning module is aligned with the PDCA methodology.
3. Quality Objectives (Clause 6.2)
Measurability: Objectives now need to be measurable “if practicable,” which is a step back from always requiring measurability.
Our insight
This could potentially create a significant issue and a loophole for organizations. Since the fundamentals of a quality management system revolve around quality objectives, not defining these objectives because it is deemed “impractical” undermines the system’s effectiveness. We strongly encourage organizations to always clearly define their quality objectives, even when it’s not mandatory, and to avoid cutting corners. Without well-defined quality objectives, it’s unclear how an organization can gauge the effectiveness of their QMS.
Isolocity QMS Capabilities:
The entire Isolocity QMS is designed to track and measure quality objectives. With Isolocity QMS, you can create both organizational and individual KPIs and monitor them through various reports and dashboards.
4. Environment for Operation of Processes (Clause 7.1.4)
- Notes on Social and Psychological Factors: Continues to mention “emotionally protective” workplace and adds “technological” and “cultural” aspects.
- Technological References: Includes terms like “AI, Metaverse, VR, chatbots.”
Our insight
We grasp the intention behind this, and it likely requires more elaboration than just a brief mention. While all workplaces should aim to be emotionally supportive, from an audit standpoint, we may need more specific details on how this would be assessed. Additionally, since this involves a different realm altogether, it’s uncertain whether any ISO 9001 auditor would possess the qualifications to evaluate whether a workplace is emotionally supportive or not.
Regarding the technological references, it’s unclear why these specific keywords are utilized. However, here are some potential examples that we believe are feasible:
- Utilizing the metaverse or VR technology to inspect the product before production begins, allowing for an understanding of its functionality and identifying any potential quality risks.
- Employing an Augmented Reality inspector to overlay real-time data onto the product, enhancing visualization and facilitating the detection of non-conformities.
- Implementing an AI Chatbot capable of analyzing data to identify potential risks and opportunities, and perhaps assisting in setting KPIs.
Once again, these examples are beneficial but not essential, as they are mentioned merely as possibilities rather than requirements.
Isolocity QMS Capabilities:
In addition to its utilization of various advanced technologies, including AI, the Isolocity QMS offers numerous other functionalities. We’ve dedicated an entire blog to explore the significance of AI QMS in quality management. If you’re incorporating any of these technologies and intend to transfer their data to Isolocity QMS, it’s achievable through our open API.
5. New Appendix
Guidance on Use of Standard: Adds a new appendix similar to ISO 9001:2015 for Small Enterprises, offering detailed guidance on implementing the standard.
Our insight
Insight isn’t necessary here; this serves as an appendix. If your company already has an established QMS, there’s no need to delve into this section. However, it could be beneficial for small and medium-sized businesses (SMBs) who are new to ISO 9001 and are in the early stages of setting up their QMS.
Conclusion
In conclusion, there are no changes from a requirements standpoint. If you wish to remain ahead, you could consider implementing some of the suggestions outlined here. However, it’s important to note that these are not mandatory requirements. Therefore, even if you choose not to implement them, there will be no negative consequences. While we’re not entirely fond of the flexibility regarding quality objectives, as this is still a draft committee, we remain optimistic that there will be improvements in the final version once it’s published.
