Understanding ISO 9001:2015
7.1.5 Monitoring and
measuring resources (MMR)
Let’s begin with some definitions:
– is a
process to determine
the property or value of something, usually expressed as a quantity, e.g. temperature, speed, weight, dimension,
is a set of
operations to determine the value of a quantity.
– may comprise of measuring
instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof
necessary to realize 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.
– 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
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.
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
Determining the suitability & precision of MMR needed for such M&M;
The acceptance criteria for product & service quality characteristics and process control
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.