Organisations are required by ISO 9001:2015 to determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. The following must be included:
Although improvement was also a requirement under the previous release of the standard, a significant change in the 2015 update is the deletion of all references to preventive action. This been replaced by risk-based thinking as discussed in detail in article 6.1, and embedded throughout the standard. It is also pointed out in the A.4 Annex of the standard that: “One of the key purposes of the (whole) quality management system is to act as a preventive tool…”
Another subtle but important change was the shift in emphasis away from improvement being only continual. Indeed, the standard points out in the sub-clause 10.1 notes that: “…improvement can include correction, corrective action, continual, breakthrough change, innovation and re-organization.” IE: It is recognised that step changes are also an important tool organisations use to improve.
Other new requirements include the “correcting, preventing or reducing undesired effects.” These could be associated with products or services provided, manufacturing / service processes, or the management system itself. The methods used to address the unwanted effects must therefore be tailored accordingly.
Note also that product and services improvements to meet not only current requirements, but also address future needs and expectations are also specified.
Opportunities and requirement for improvement may be derived from any source and at any level in an organisation, many businesses derive their improvement objectives from three key areas however:
Whilst improvement need not be directly associated with established quality objectives, improvement requirements are often a logical output of the process. IE: High level objectives initially be set by top management, may in turn lead to further supporting objectives and enabling improvement programmes or initiatives.
Below are high level examples of areas which may be selected for improvement in a typical organisation along with possible tools which may be used to execute. (Note: These tools and methodologies are just a few examples and include some of the more advanced methods available. Once improvement opportunities have been identified, there is no prescriptive methodology on how improvements should be executed. These example are therefore not prerequisites and indeed, simple is often the best!)
DMEDI Six Sigma, Competitor Benchmarking, Cause and Effect Diagrams, Voice Of the Customer, DFMEA, Lesson’s Learned Feedback.
DMAIC Six Sigma, Value Steam Mapping, statistical analysis, Design of Experiments, Process Flow Charting, 5S, Brainstorming, Kaizen, Poka-Yoke, PFMEA, 5Y’s, 8D.
Audits, Plan-Do-Check-Act methodology, Organisational structure changes, Training.
Note: It is also important to remember that in any organisation, resources are finite, and there is no requirement for organisations to improve all areas simultaneously. Focus should therefore be on “the vital few”. See also article 10.3 – Continual Improvement
Auditors are advised to determine through objective evidence, if top management are actively looking for opportunities to improve and if so, that objectives have been set and plans put in place to improve products or services, processes and management systems performance. IE Through the gathering, analysis and evaluation of data and execution of improvement plans.
This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!
David Barker CQP MCQI