ISO 9001 Clause 7.1.5 – Monitoring and Measuring Resources

Let’s turn our attention to the fifth sub-clause in ISO 9001 Clause 7.1 – Monitoring and Measurement Resources.

What does it mean, and how does it work with the rest of your certification?

According to the International Organisation for Standardisation (the main ISO body), by December 2021, more than “one million companies and organisations in over 170 countries certified with ISO 9001:2015”

Is it time to join them?

We would say yes! Though we always caution - ISO 9001 might just be the most confusing document in business history!

That’s why this series of articles and accompanying free factsheets have been written. Their purpose is to:

• Cut through the jargon
• Debunk the myths
• Make smoother sailing of your journey to certification

So if you’re wondering about working towards ISO 9001 certification, we’d like to help get you there – taking the sting out of that dire warning!

Let’s get to it – here’s a breakdown of ISO 9001 Clause 7.1.5 –  Monitoring and measuring resources.

What is ISO 9001 Clause 7.1.5.1?

This sub-clause requires you to identify and provide the right resources for monitoring and measuring activities. The purpose is to ensure you get valid, reliable results when checking if your products and services meet requirements. 

It basically says: make sure you have the right tools and methods to check that your products and services are meeting the required standards.

The resources you need will vary significantly based on what your business does and how your quality management system is set up. Sometimes a simple check or basic monitoring will be enough to determine the status and verify everything is correct.

An example of this is a quick visual check to ensure you've got the right number of items in a package.

Other times you'll need precise measurements. This may involve using equipment that's been properly verified or calibrated, to ensure accurate information.

Monitoring and measuring - what’s the difference?

Monitoring means systematically observing, supervising, and checking to assess the status of your activities, processes, products, or services.

This could involve verifying correct quantities, confirming orders are complete, using gauges to check if something's working properly, reviewing customer service calls for quality, or gathering feedback during service delivery.

Measurement involves determining specific quantities or dimensions using appropriate measuring tools.

Do you manufacture widgets that have to be an exact size? You’ll need tools that deliver precise measurements when you check them. This may require calibrated equipment that can be traced back to national or international standards. For services, you might use validated feedback models or established evaluation methods.

What needs to be monitored or measured?

You need to consider how critical your monitoring and measurement activities are for determining whether your products and services meet requirements. I suggest you:

• start by identifying what needs to be monitored or measured across your processes, products, and services.
• determine what resources you need to do this effectively.

It is also a requirement of the standard to keep documentation that shows your monitoring and measuring resources are suitable for their intended purpose.

This may include:

• maintenance schedules to ensure ongoing validity
• evidence of traceability to official standards or other approved methods.

Other situations require expert evaluation to confirm proper delivery. This will mean having qualified professionals assess the work. Or you may need to develop specific evaluation tools, such as assessment criteria or scoring systems, to verify that requirements have been met. 

Just ensure your approach to monitoring and measuring matches how critical conformity is for your organisation. It must give you confidence in your results, as you may need to explain your methods in audit.

What is ISO 9001 Clause 7.1.5.2 – measurement traceability?

It’s necessary to maintain confidence in the validity of your measurement results. That’s the purpose of this sub-clause - to ensure that your business provides measurement traceability when required.

Is your measuring equipment used to verify conformity and ensure measurement validity? If so, you should establish processes for the verification, calibration, control, storage, use, and maintenance of this equipment.

The calibration and verification status of measuring equipment must be clearly identified, including:

• whether equipment has been calibrated or verified
• the extent of calibration
• the validity period.

This identification may be displayed on the equipment itself, or its container. Alternatively, it can be logged through administrative systems such as unique identifiers linked to equipment databases.

Tools with adjustable calibration features should be protected against accidental modification. This can be achieved by securing or covering adjustment sections to prevent disruption during handling or use.

For equipment susceptible to vibration or shock that could affect calibration status, protective measures such as customised cases or specialised packaging should be implemented.

Calibrate or verify?

Calibration is testing your measuring device against a known accurate standard to see if it's giving you the correct readings. 

Think of a digital thermometer used in a restaurant's walk-in fridge. It needs to be calibrated to ensure food safety. Once a year the thermometer is sent off for calibration, and a certificate is held on file.

Verification involves the same sort of checking as calibration, but it happens in between calibration cycles. 

In our example of the thermometer, you can use the ice-water / hot-water method: place the thermometer in a container of ice water (which should be exactly 0°C) and see what it reads, and then in boiling water (which should be exactly 100°C). 

The purpose of verification is to detect small changes in an instrument’s accuracy. It may trigger an earlier calibration if it goes too far out of true.

When to calibrate?

You need to decide how often calibration and/or verification is required. In ISO speak – these are the ‘specified intervals’.  Manufacturers of measuring equipment often establish recommended calibration frequencies for their equipment, and I recommend using these instructions.

Once you have determined the frequency with which each piece of equipment must be calibrated and/or verified, I recommend documenting this in a ‘calibration schedule’.  This could be a list, file, spreadsheet, online database – whatever works for your business – the purpose is to determine when devices are due for calibration, and ensuring it happens. 

Records of calibration / verification

ISO 9001 requires records of ‘fitness for purpose’ of monitoring and measuring resources, and calibration falls into this category. The records of calibration usually contain the following:

• Serial number
• Date of calibration
• Who carried out the calibration
• Results of the calibration
• Any adjustments required
• Results of the calibration after the adjustments
• Process used in the calibration
• Next calibration date

What if your measuring equipment is found to be inaccurate, and thus unfit for purpose? In that case you must review the potential impact, and take appropriate action. This may include sampling affected products to check they are still within acceptable tolerance levels.

Review results may indicate various responses: no action required, service repetition, stock investigation, customer notification, or product recall. The level of action depends on the actual or potential impact on product and service conformity and any associated risks. 

Whatever your decision regarding the piece of equipment, you must record it and the action taken.