The latest revision to the ISO 9001—the leading quality management standard—has introduced numerous important changes to improve the standard and its implementation.
Among other things, ISO 9001:2015 aim is to help companies improve their operational efficiency and take greater advantage of opportunities in a context of complex global supply chains.
Here are five key changes from the previous version of ISO 9001.
1. Consistency across standards
To make it easier for people using multiple management systems, ISO 9001:2015 follows the same structure as other ISO standards, making integration easier and the audit process simpler.
2. Risk management plan
The new ISO 9001 standard requires businesses to use “risk-based thinking” to identify, consider and control the risks that are inherent in any system, process or function. While risk management was previously separated from the rest of the quality management system, risk now has to be considered at every step of the “plan-do-check-act” cycle.
3. Measurable objectives
Applying the new standard will require more involvement from company management. Clear and specific objectives must not only be set, but progress toward their achievement monitored. The objectives must also evolve over time. They now have to be reviewed at least once a year, and they’ll have to be properly communicated to employees, who will also be more involved in the process.
The new standards are less prescriptive and focus on what has to be achieved rather than on how to achieve it. In particular, the 2015 version does not require a specific documentation procedure. It leaves it to the organization to assess its own documentation needs in terms of managing processes, taking into account client requirements and its own regulatory framework.
5. Satisfaction and compliance for all parties
The goal of the new standard is still to ensure product and service compliance in order to meet client expectations. However, the 9001:2015 versionsgoes beyond the client relationship to encompass relationships with all parties, including end users and regulatory organizations.