An ongoing series of Posts: Practical advice on Clause 9.1.3 of ISO 9001:2015
Purpose of ISO 9001:2015 Clause 9.1.3
The intent in sub-clause 9.1.3 is for the organization to analyse and evaluate data and information from the results of monitoring and measurement, so to determine:
- if processes, products and services meet requirements,
- if corrections and corrective actions are needed,
- If decisions based on risk-based thinking were satisfactory, and
- opportunities for improvement.
Working with Data
Data selected should focus on providing results to evaluate the performance and effectiveness of the quality management system and determine the need for any improvements. Here are some typical data sources:
- product: yield; conformity to specific requirements (e.g. customer, statutory, regulatory); rates of non-conformities [e.g. parts per million (ppm)]; scrap and rework; on-time delivery; fulfillment of order;
- service performance: queuing times; indication of resolution of customer issues; ease of access; cleanliness; housekeeping; friendliness;
- results from monitoring of customer perception;
- delivery of projects to plan (e.g. budget and timing);
- review of action items on risks and opportunities (e.g. meeting minutes);
- on-time delivery and quality (e.g. rejects) for external providers;
- status of quality objectives.
Typically, output from analysis and evaluation is documented as:
- trend analyses or reports,
- balanced scorecards,
and becomes an input to management review or meetings that consider the output.
Do's and Don'ts in Analysis and Evaluation for ISO 9001
- Do ensure that the output from analysis and evaluation is in a suitable format. It should allow a determination to be made of whether actions are needed to improve the quality management system – this is of prime importance here.
- Do determine the appropriate frequency for evaluating and analysing the information. Information could be analysed daily, weekly, monthly, annually depending largely on the use you will make of it.
- Do make every effort to retrieve information electronically. Avoid manual preparation of data if possible.
- Do ensure that the methods and data quality provide useful information. These data should be representative, unbiased, complete, and accurate. Best of all, they should be capable of being used for managerial decisions.
- Do use statistical techniques for the analysis and evaluation processes. Check-out Minitab.
- Don’t forget to evaluate the information you have decided to monitor. Analysing lots of raw data is not sufficient to meet the requirement here. You are recommended to interpret the word ‘evaluation’ to mean converting the analysed data into a format that will facilitate decision-making and follow-up action by management or other interested parties.
- Don’t continue to collect and evaluate information if no use is being made of it. If no decisions and/or actions arise from the evaluated information, drop that data source from your programme. And never collect and evaluate data for the benefit of your CAB (Certification Body) alone.
- Don’t forget that there are seven headings in this sub-clause where analysis and evaluation are required. Your CAB Auditor will be asking for evidence that you have addressed all seven – a list like this in a Standard constitutes ‘low-hanging fruit’ for an Auditor.
ISO Sub-clause 9.1.3 is a new clause for a reason. Too often in the past, very low-grade information was developed in QMSs. This was of little use to top management in making useful decisions about the status and future development of their QMS.
The expectation now is that analysed data will be evaluated so as to facilitate decision and actions regarding the QMS being taken. Your ISO 9001 Certification Auditor will be seeking out this linkage.
This is part of an on-going series of posts on the DO's and DON'T's of implementing and maintaining a QMS. Use the Search field at the top of this page to find the others.
Reference: ISO/TS 9002:2016, Guidelines for the application of ISO 9001:2015