ISO 9001 Quality Improvement

ISO 9001 Quality Improvement

ISO 9001 Quality Improvement – Time for a return on investment

ISO 9001:2015 Clause 10 Quality Improvement, I would prefer to call this clause – ROI or return on investment. If you are running an effective Quality Management System, you have invested a lot of time, money, and effort to get to this point. Clause 9 focuses on evaluating the performance of your QMS and then based on that improving your system. Improvements to your QMS can be on the back of positive feedback, ideation and improvement opportunities, or negative issues such as customer complaints of audit non-conformances. Whatever the driver may be, he is your opportunity to improve your QMS, take action to prevent recurrence of negative issues or enhance business performance or that of the QMS through leveraging opportunities.

Clause 10.1 Improvement – General

Your organization must discover opportunities for improvement and implement any actions necessary to meet requirements that may stem from the business or the customer. The end goal of which is to ensure that you achieve the intended outcomes of the QMS. Opportunities for improvement could be associated with:

  • Improvements to products or services:
    • New product & service development to meet future customer needs
    • Improvements to existing products & services
  • Protecting against undesired effects:
    • An example could be to improve the procurement, logistics and warehouse processes to better protect raw materials and finished goods.
  • Improving the suitability, adequacy, and effectiveness of the QMS
    • An example could be to update the auditing process to audit certain processes more regularly due to an increase in product-related issues.

Clause 10.2 Improvement – Nonconformity and Corrective Action

Your organization is required to report, investigate, identify the root of contributing factors to detected nonconformity, take action to address root causes and review the effectiveness of actions taken. The purpose of which is to prevent the recurrence of these issues.

A nonconformity is a nonfulfillment of a requirement, and corrective action is an action taken to address the nonconformity and prevent a recurrence, examples of this could be:

  • An audit finding
  • A Customer Complaint
  • A supplier delivery issue (late delivery, damaged goods etc)
  • A trend of product which is out of specification

My experience to date has shown that many improvements recur due to superficial investigations, incorrect root causes and the effectiveness of actions taken are not being reviewed.

Consider the cost of non-conformances on your products, services, and reputation, thus every effort should be bid to address non-conformances correctly to prevent a recurrence. When it comes to non-conformances, I believe the following applies, “to err is human, but to forgive is divine”, the point being is that everyone makes mistakes, however, how we address those issues is what separates one company from another. My experience has been that most customers will buy your product or services (after a non-conformance) if you can demonstrate that you have addressed the issues adequately.

Clause 10.3 Improvement – Continual Improvement

At this point, we must address the difference between continuous improvement and continual improvement, as they are often incorrectly assumed to be the same.

Continual improvement means that the approach is repeated and has pauses in between repetitions. A continual approach will have a phased system, whereby improvements will be made then there will be a break to measure and analyses the success, after this further improvements can be made. ISO 9001:2015 Clause 10.3 refers to continual improvement.

Whereas a continuous improvement approach does not stop, it is an uninterrupted flow. A continuous approach is one that will constantly look to make improvements, it is a sustained process of development.

Your organization is required to continually improve the suitability, adequacy, and effectiveness of the QMS. This is achieved through considering the results of performance evaluation and management review to determine if there are needs or opportunities for improvement.

Examples of this could be:

  • The management review confirms that the organization is hamstrung but a documented QMS and would benefit from digitizing their QMS into a cloud software solution. This would be a continual improvement opportunity.

Use SHEQ software

To design and implement a Quality Management System, SRM and many of our clients use Mango Compliance Software – www.mangolive.com  Mango makes it easier to obtain ISO 9001:2015 certification and to log and action improvements.

In Summary

  1. Quality Improvement is an intended outcome of any good QMS
  2. Develop a process that allows for the reporting, investigating, root cause analysis, corrective action and effectiveness review
  3. This is an incredible opportunity to get a return on the extensive investment you have made into your QMS

SRM is ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 certified. Contact our consultants today. Let us know if we can help you with the development and implementation of your Quality Management System.

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