ISO 9001 Revision explained in simple terms
Work at the Revisions of ISO 9001:2015, ISO 9000:2015 and ISO 14001:2015 is continuing. In mid-April, the final meeting relating to ISO 14001 took place in London. The result is extremely positive for the users: Even ISO 14001 is to be published in September 2015. At Quality Austria, the preparations run at full speed. Workshops are held with our auditors in order to analyse the requirements and guarantee an adequate further development of our qualityaustria audit procedure. Now the transitional rules are being defined while considering the international and national requirements.
In a series of technical lectures, Quality Austria provides information on the revision of ISO 9001:2015. Each month, a key concept of the revision will be explained more profoundly. This month, Wolfgang Hackenauer, MSc, explains the requirements relating to the topic of “performance Evaluation”
Understanding performance evaluation
Wolfgang Hackenauer, MSc
The autonomous Clause “Performance evaluation” has been newly taken up to ISO 9001:2015. In this respect, “performance”, i.e. the measurable results, can refer to the management of activities, processes, products (including services), systems or organizations.
What approach is pursued by ISO 9001:2015?
Establishing a quality management system is a strategic decision taken by the organization. External and internal topics (cf. Clause 4, Context of the organization), which are relevant for an organization’s purpose and strategic alignment, determine the objectives (i.e. the results to be achieved) of the quality management system. Depending on the objectives, process and activities will be planned. If these activities are carried out as planned and the objectives are achieved, this means that the system is “effective”. These explanations are important for understanding evaluation of “performance and effectiveness” of the quality management system, which is now required in ISO 9001:2015. Clause 9 “Performance evaluation” is broken down into 9.1 “Monitoring, measurement, analysis and evaluation”, 9.2 “Internal audit” and 9.3 “Management review”. The most important innovations are part of Clause 9.1. In Clause 9.1.1 “General”, the normative relationships are discussed.
The Figure gives a rough overview of the specification elements in connection with 9.1 “Monitoring, measurement, analysis and evaluation” to be considered, the concrete requirements to be met and the commensurate aspects (e.g. knowledge). The arrows on the left side show what specification elements are related to “Monitoring, measurement, analysis and evaluation”. This means that the topic draws a red-thread path through the Standard. The central part of the Figure shows the concrete needs for action, e.g. the necessity to determine what needs to be monitored and measured.
Clause 9.1.2 deals with the known topic of customer satisfaction. The Figure shows the specification elements, activities as well as possible effects on topics leading further (e.g. management review). The organization is to strive for increasing customer satisfaction by effectively utilizing the system. In ISO 9000:2015, the “Standard of Terminology”, customer satisfaction is defined as “the customer’s perception of the degree to which the customer expectations have been fulfilled.” Customer satisfaction needs to be dealt with when planning and making the management review.
Clause 9.1.3 “Analysis and evaluation of data” deals with the topics to be concretely analysed and evaluated according to the Standard. This Figure shows the interrelations between the specification elements to be considered, the concrete actions and the topics leading further.
“The organization shall analyse and evaluate appropriate data arising from monitoring, measurement and other relevant sources.” (ISO 9001:2015).
The results of analysis and evaluation shall be used to evaluate the following:
- conformity of the products and services,
- customer satisfaction,
- performance and effectiveness of the quality management systems,
- effective implementation of planning,
- effectiveness of the actions in terms of risks and opportunities,
- performance of external providers,
- the need for improving the quality management system.
An interesting link can be established between this Clause and the principles of quality management. These principles also are anchored in ISO 9000:2015. One principle deals with “evidence-based decision-making”. “Decision-making can be a complex process and always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.”
Besides Clause 9.1 “Monitoring, measurement, analysis and evaluation”, which has been discussed, there are the specification elements 9.2 “Internal audits” and 9.3 “Management review” in Clause 9 “Performance evaluation”. At this point, these elements are not discussed in more detail.
Below, we will try to provide the actions required by the Standard with possible remarks or methods. This can provide support when it comes to implementing the changed requirements.
Step 1: Determining what needs to be monitored and measured
Considering the requirements of the Standard and own definitions; possible examples of definitions can be based on: strategy, opportunities and risks, defined objectives for processes, functions and levels, customer requirements or legal obligations
Priority “Customer satisfaction” (9.1.2) Monitoring of the customer’s perceptions - obtaining information on the customer’s impression about the degree to which their expectations have been fulfilled - determining the methods for obtaining, monitoring and evaluating this Information
Examples of “monitoring of customer perception” might be: customer surveys; customer feedback about products delivered or services provided; meetings with customers; analyses of market shares; recommendations; warranty claims; reports made by merchants
Step 2: Establishing methods for monitoring, measurement, analysis and Evaluation
For presenting the aspects determined, (which are required in the Standard, including the own definitions) to be monitored, measured, analysed and evaluated, a data sheet might be thought about. This data sheet might show
- what needs to be monitored and measured,
- when and how often this needs to take place (intervals),
- who (persons, group) needs to carry this out,
- the method (see above) Information adequately documented needs to be retained.
Step 3: Determining when monitoring and measurement need to be carried out
Information given in the data sheet
Step 4: Determining when the results of monitoring and measurement need to be analysed and evaluated
Information given in the data sheet
Priority “Analysis and evaluation” (9.1.3) - considering the results required from a) to g) - using the results and assessment as inputs in management review
Information given in the data sheet
Step 5: Retention of suitable documented information as evidence for the results
e. g. “recording matrix”
Step 6: Performance evaluation and effectiveness of the quality management System
Evaluation of the single results, which is directly done by the competent persons → deriving actions; overall assessment at a system level: this is part of management review