ISO 9001 Requirements
ISO 9001 Requirements Clause 7.1.5 Measuring and monitoring resources (MMR)
Let’s begin with some definitions:
Measurement – is a process to determine the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension, etc.
Measurement process – is a set of operations to determine the value of a quantity.
(MMR) Measuring equipment – may comprise of measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.
Monitoring – determining the status of system, a process, a product, a service, or an activity. For the determination of the status there can be a need to check, supervise or critically observe. Monitoring is generally a determination of the status of an object, carried out at different stages or at different times.
Metrological characteristic – a characteristic which can influence the results of measurement. Measuring equipment usually has several metrological characteristics which can be the subject of calibration.
An organization provides various products and services and may use a number of processes to produce them. ISO 9001 requires:
· Measuring various quality characteristics (material, dimensional, functional, durability, safety; etc) of these products and services to defined criteria to verify conformity to requirements,
· Monitoring key process variables (temperature, pressure, flow rate, time, mix rates, concentration of processing liquids, etc) to ensure these processes operate within controlled parameters.
Note: There can be quite a wide diversity and range of MMR’s that can be used within different organizations – the scope and type and complexity of measurements and monitoring; risks associated with your PS and MMR, etc. Accordingly, you must customize your MMR procedures and controls to suit the specific needs of your organization.
Your MMR procedures and controls (documented or not) must include:
· Determining the specific product or service quality characteristics or process variables that need to be measured and monitored;
· Determining the suitability & precision of MMR needed for such M&M;
· The acceptance criteria for product & service quality characteristics and process control variables;
· Ensuring calibration traceability to national or international standards;
· The timing & frequency – when & at what stages of the realization process to do MM; how often to do it and the sample size for M&M; etc.
· Responsibility, competence and training for MM activities;
· How (methods) such MM activities will be performed;
· Performing a risk assessment to evaluate the risks related to MMR and their use and take appropriate risk mitigation steps (see clause 6.1);
· Determining what records are needed as evidence that MMR are fit for purpose, i.e. conducting MM activities & providing reliable results;
· Using appropriate performance indicators to evaluate the effectiveness of the use of MMR.
· Applying the PDCA approach to control the process for using MMR as explained in this section.
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article on this clause discusses in detail how to implement the various controls listed above as per the requirements of clause 7.1.4.