This white paper aims to:
- Explain the changes in the revised standard of ISO 9001:2015.
- Look at the effect of these changes on weighing devices and weighing processes.
- Provide guidance and recommendations on compliance with the risk-based process approach
- Introduce Good Weighing Practice™ - a perfect fit with ISO 9001:2015
- which provides an easy way to implement the risk-based approach
to a Quality Management System.
What is ISO 9001?
ISO 9001 is a standard that defines the requirements for a quality management system. It has been helping businesses and organizations to increase efficiency and improve customer satisfaction since 1987. ISO 9001 is updated regularly to maintain relevance to the current business environment. The current version was published in September 2015 (ISO 9001:2015).
As ISO 9001:2015 is flexible any type of organization, it deliberately does not specify what the “quality” or “meeting customer needs” objectives should be. Instead, it requires organizations to define these objectives themselves and continually improve their processes in order to reach them, using a risk-based approach.
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What is the “risk-based approach”?
A risk-based approach requires that organizations identify, assess, and understand the risks and opportunities to which they are exposed. Then, they must rate these risks into acceptable and not acceptable levels and take the appropriate mitigation measures in accordance with the level of risk. ISO 9001:2015 requires risk-based thinking and decision making.
How does ISO 9001 apply to measuring instruments?
Measurements, including weight, are often critical process steps, which can have a significant effect on quality of the end product. For this reason, weighing and measuring devices must be considered within the process requirements and risk-based thinking approach outlined in the ISO 9001:2015.
ISO 9001:2015 explains requirements for measurement devices in chapter “7.1.5 Monitoring and measuring resources”. It describes the suitable selection and maintenance of such devices. The metrological traceability (achieved by regular calibration) is a requirement in a separate paragraph.
Is there a change regarding measurement instruments in ISO 9001:2015?
Although the wording is different in comparison to the previous version, there is no substantial change in the requirements regarding measurement instruments. Procedures that fulfilled the “old” version will also fulfil the new requirements.
What are the main changes in the 2015 version?
ISO-9001 has a new structure and now follows the same overall High-Level-Structure (HLS), developed within the ISO community, as other ISO management system standards. This provides consistency and makes it easier for anyone using multiple management systems (e.g. environmental management, quality management).
2. Leadership and commitment
The ISO-9001:2015 revision requires top management to demonstrate leadership and commitment to the Quality Management System (QMS). It makes management accountable for the effectiveness of the QMS, ensuring resources are available, and promoting continuous improvement. However, the use of the process approach and risk-based thinking is not just the responsibility of management. It should be everyone's business, and should become an integral part of the organizational culture. In other words, quality becomes a company-wide practice and not solely the specific responsibility of the quality manager, or the quality department.
3. Process approach
A process approach has been an important part of ISO 9001 since 2000 and continues to be in the 2015 version. The revision has a focus on improved process performance by adopting a Plan-Do-Check-Act (PDCA) cycle to manage processes, and the interaction of those processes as a system, with an overall background of risk-based thinking. It is important to recognize that not all processes have the same impact on an organization's ability to deliver conforming products and services. Moreover, the new changes are not prescribed, but are left to the manufacturer to evaluate based on their processes, associated risks and their customer's expectations for high quality.
4. Risk-based thinking
One of the key changes in ISO 9001:2015 is a focus on risk-based thinking. The new version gives it increased prominence by building it into the whole management system. In previous editions of ISO 9001, a clause on preventive action was separated from the whole. The aim is to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system. Risk-based thinking is part of the process approach