ISO 9001 Improvement
What gets measured gets done, and in this case, improved. There is no way to know what aspect of your company that needs to be fixed or improved if you don’t first measure it. This means measuring the right things in the right way and reporting the results to those who can drive changes. As we continue with the EBS DIY ISO 9001 implementation series of articles, let’s dig in and take a look at the following ISO 9001 improvement clauses:
- 1.1 – Monitoring, Measurement, Analysis, & Evaluation (General)
- 1.3 – Analysis & Evaluation
- 10 – Improvement (General)
- 10.3 – Continual Improvement
Improvement is generally accomplished through the application of several other clauses starting at the highest-level business and quality objectives (ISO 9001-6.2), management system changes (ISO 9001-6.3), management review (ISO 9001-9.3), and corrective action (ISO 9001-10.2).
Monitoring and Measuring
- What to measured and monitored,
- The methods to be used to assess performance,
- When these methods are to be performed,
- When the results are to be analyzed and evaluated.
As you create your performance evaluation methods, make sure that they address all of the above items. This can be accomplished with something as simple as a spreadsheet or table identifying key measures and how each of the above are satisfied.
Business Objectives and Metrics
Monitoring and measuring starts with established quality or business objectives. One method of monitoring objectives and system performance is through the use of audits, whether 1st party (internal audits), 2nd party (customer), or 3rd party (ISO registration) audits. Audits are great tools for assessing the overall management system performance and effectiveness and identifying areas of the system which need change and improvement. Depending on the depth of and methods used to complete the audit, just about any aspect of the organization and management system can be assessed at some level.
Quality objectives should be defined at the highest level of the organization and reflect initiatives that are strategic in nature. However, these objectives usually don’t fully measure and assess performance at all levels of the organization. Most companies define more tactical performance measures (metrics, KPIs, etc.) and reporting tools to measure the performance at functional levels of the organization. While metrics and key performance indicators are not specifically required by ISO, we don’t see how you could effectively govern an organization or satisfy the ISO 9001 improvement and performance evaluation requirements without some type of established measures or metrics. The nature and type of metrics established should be determined by the size of your organization, the complexity of your processes, the type of products and services offered, your organizational culture or environment, and the level of risk to be managed within your organization.
Analysis and Evaluation
ISO 9001 requires the data and information gained during monitoring and measuring activities to be analyzed and evaluated. The results of this analysis are used to evaluate the following:
- Conformity of you products and services,
- Customer satisfaction,
- Overall performance and effectiveness of the management system,
- The effectiveness of planning activities,
- The effectiveness of risk management activities,
- External provider performance,
- The need for improvement activities.
The ISO 9001 standard includes a note stating that analysis methods can include statistical techniques and we definitely recommend utilizing some form of statistical analysis when evaluating performance data. This doesn’t need to be complicated, as a simple metric which measures the mean or average of a performance indicator is a statistical technique. You are probably already using some simple statistical methods somewhere within your organization.
If you don’t think so, just go look at your financial reports (balance sheet, cash flows, income statement, payroll, etc.).
Much of the analysis and evaluation requirements can be satisfied through other management system processes such as management review and strategic planning. Any other action or activity that involves the review of performance information and which result in decisions to drive changes and improvement work to satisfy the requirements under ISO 9001-9.3.3.
Section 10 of the ISO 9001 standard is all about improvement of the management system, especially improvement actions taken towards meeting customer requirements and enhancing customer satisfaction. This is the last section of the standard which is all about “Act” within the PDCA cycle. We see references to improvement through the entire ISO 9001 standard with the word “improve” appearing 20 times within 13 different clauses demonstrating the importance of improvement and how it integrates within the entire standard.
Since we covered clause 10.2 (Nonconformity and Corrective Action) in a previous article, that leaves clauses 10.1 and 10.3 to address in at this time and these ISO 9001 improvement requirements are generally satisfied through effective execution of the following processes:
- ISO 9001-9.3, Management Review,
- ISO 9001-10.2, Nonconformity and Corrective Action,
- ISO 9001-9.1.2, Customer Satisfaction, Feedback, & Complaints,
- ISO 9001-9.1, Internal Audit.
One of the best ways to demonstrate improvement is through execution of activities to implement the quality (business) objectives discussed above. You can also show improvement through your corrective action system which links to audit findings, nonconformities (product, service, process), complaints and feedback, risk management, and management review. The bottom line is that your organization should develop and implement core processes to identify and execute improvement opportunities and strive to embed a culture of continuous improvement within and throughout your organization.
Make sure that employees understand and are aware of the need to continuously be seeking and identifying new opportunities for improvement throughout the organization. You may recall that this is a requirement under clause 7.3 (Awareness) and clause 5.1.1 (Leadership and Commitment).
ISO 9001 improvement clauses provide a platform for measuring and evaluating organizational and management system performance, and where warranted, taking action to improve the system and associated processes. This requires establishment of quality objectives and underlying key measures (metrics) to track and measure performance. All of this data and information is rolled-up and reported to the organizational leadership, usually during management review meetings and other periodic strategic planning initiatives.