ISO-9001 calibration requirements

ISO-9001 sets standards for businesses around the world, and it has big implications for how quality managers go about calibrating measuring equipment for precision engineering. Getting this equipment up to the calibration level required by ISO can be time consuming and a drain on resources - if you don’t have the right help.

Ensuring that equipment meets ISO-9001 requirements is especially important for satisfying the expected level of quality management in industries like aerospace, defence, medical and automotive. In these industries, companies will frequently only work with or buy from suppliers that are approved to ISO standard.

But what exactly are the calibration requirements needed to achieve certification and pass your ISO audit? We explain everything you need to know about getting your equipment up to ISO standard, and how you can make sure it gets done efficiently.

What does ISO-9001 say about calibration?

Calibration makes up just a small part of the ISO-9001 document, so it’s important to know where to look. The most up-to-date version is ISO-9001:2015, and the stipulations on calibration can be found under clause 7.1.5 in a section called Monitoring and Measuring Resources.

This clause is then split into two further sub-clauses:

7.1.5.1 - General

This sub-clause explains the general premise of Monitoring and Measuring Resources. It states that:

The organisation shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organisation shall ensure that the resources provided:

Are suitable for the specific type of monitoring and measurement activities being undertaken
Are maintained to ensure their continuing fitness for their purpose

The organisation shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

In practice, the sub-clause has a simple meaning. When ISO-9001 says “resources” it is referring to monitoring and measuring equipment. In the case we are interested in, this means calibration instruments. These instruments must be:

Directly appropriate to accurately assess the type of product or activity they are being used for
Regularly monitored to ensure they meet the standards required
Accompanied by sufficient documentation to prove they are fit for their purpose

7.1.5.2 - Measurement Traceability

This sub-clause looks further into the actual calibration standards required:

When measurement traceability is a requirement, or is considered by the organisation to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information
Identified in order to determine their status
Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results

The organisation shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

The dense language used in this section can easily obscure its meaning. The salient points from sub-clause 7.1.5.2 are:

Again, the clause only applies where measurement traceability (ensuring calibration equipment is accurate) is vital to the activities of a business
Equipment must be calibrated to an industry’s recognised standard (national or international). In the unlikely event no such standard exists, they must show the logic they’ve used to pass their equipment as fit
Equipment must be protected from suffering any alterations that would render them unreliable
If equipment is found to be inaccurate, a business must declare this and find out whether it has affected past results

What do you need to do to meet ISO-9001’s calibration requirements?

Extensive quality management is needed to satisfy ISO-9001’s calibration requirements - and certainly more actions than there is space to include in this article. However, some key fundamentals include:

Calibration status. Having clear visibility over how recently a piece of equipment has been calibrated is essential, as is visibility over when it will next be calibrated. While this information needs to be documented in detail, each individual calibration device should be labelled with these two dates for the avoidance of mistakes.
Protection from adjustments. Equipment passing an ISO audit is no good if the working environment it operates in causes it to lose its accuracy. Multiple steps should be taken to ensure this doesn’t happen - for example regulating who uses the equipment and in what way.
Preventing damage. The components or services that a business offers are only as good as the calibration equipment regulating them. Therefore, just as much care should be taken in safeguarding this equipment as in the manufacturing of the components themselves.
When things go wrong. Even with the most exacting calibration standards, occasionally instruments will fall outside the boundary of accuracy. In this event, you must ensure there are protocols in place to quickly identify:

The nature of the problem
The extent of the inaccuracy
The affected components and processes
The action required to resolve any issues within ISO guidelines

Taking care of calibration with DM Systems & Test

Quality managers in certain manufacturing sectors know that compliance with ISO-9001 calibration requirements is vital to their business’ viability. It’s certainly not something that can be left to chance, as a failed audit or chronic issues with calibration can be disastrous.

But on the other hand, calibration is a time-consuming process; every extra day taken is a day where a manufacturer isn’t able to give their components the final seal of approval. This is where DM Systems & Test can help. We guarantee the highest standard of calibration - fully compliant with ISO-9001:2015 - with a rapid turnaround, ensuring your equipment doesn’t need extensive downtime.

We excel in both electrical and mechanical calibration. When you choose DM, you can be sure that:

Most equipment will be fully calibrated and returned in 5 working days, with expedited turnaround also available
We will collect your equipment and return it directly to you, With our catchment area
A team of fully trained and highly experienced engineers to service your equipment
Equipment will be labelled according to your requirements and sealed for integrity
A certificate of calibration containing measurement results confirming conformance to specification
Close communication every step of the way ensuring your requirements are met and you are kept fully informed.

To learn more about how DM can take care of calibration for all your measuring equipment, contact us today.