ISO 9001:2015 requires you to determine, monitor and measure output. However, ISO 9001:2015 does not prescribe specific key performance indicators (KPIs) you must track. Neither does it prescribe how you should monitor or measure your quality management system, when to monitor or measure your quality management system, or how and when you should analyse and evaluate your key performance indicator data.
All of these decisions must be made by the organisation.
So how do can you choose what KPIs to monitor? And how often should you track them?
In this article, quality guru Richard Green, founder and MD of Kingsford Consultancy Services gives you three tips to choosing your key performance indicators.
1. Base Your KPIs on Your Quality Objectives
Your quality objectives should be SMART, e.g. Specific, Measurable, Achievable, Realistic and Time-bound. Clause 9.1.3 'Analysis and Evaluation' requires the organisation to analyse and evaluate appropriate data and information that it has obtained either externally or internally for a variety of pre-defined purposed (e.g. linking back to your quality objectives).
It requires you to analyse data and information to evaluate:
- The conformity of our products and services e.g. % of reworks or acceptance test results.
- The degree of customer satisfaction e.g. Net promoter score.
- The performance and effectiveness of our QMS e.g. use EQMS Dashboard to measure activity.
- Whether planning has been implemented effectively e.g. track number of non-conformities.
- The effectiveness of actions taken to address risks & opportunities e.g. business growth due to identifying new opportunities.
- The performance of external providers e.g. supplier rating scorecards.
- The need for improvements to our QMS e.g. managing issues.
So, as a minimum, you should construct your quality management system key performance indicators which evidence the above.
2. You can choose both qualitative or quantitative Key Performance Indicators
A principal change in ISO 9001:2015 is that you must determine the degree (i.e. how much) the customer perceives their needs and expectations have been met. So, how can you obtain and use customer satisfaction information?
You can measure whether customer expectations have been met both quantitatively or qualitatively, for example:
- Net Promoter Score (NPS)
- Satisfaction Benchmark Survey
- Revenue driven by existing customers or customer retention analysis
- Feedback forms
- Issue analysis / audit results
- Workshops with customers
Furthermore, clause 6.2 requires organisations to set quality objectives for relevant functions, levels and processes within its quality management system, so it may be that you use different types of feedback for different areas of your organisation.
3. Focus on trends over time
ISO 9001:2008 required evaluation of trends in data or information relating to products and processes. ISO 9001:2015 extends this and explicitly requires top management to consider trends at management reviews.
This means it is necessary to examine performance through time, not just a single point in time. Although the frequency will depend on the context of the organisation, for example, a consultancy firm will require a different number of KPI reviews than a medical device manufacturer, a system such as EQMS which gathers data from across your organisation and notifies relevant parties when there is something outstanding can help provide a robust, systematic and agile system.
So, when determining how often you will review your outputs it is necessary to consider what is reasonable for the context of the organisation.
Successfully transitioning to ISO 9001:2015 requires robust, agile and flexible systems. EQMS software consolidates and integrates all of your quality management system initiatives across your organisation in a single solution.