Ensuring ISO-9001 calibration compliance for your business: practical guidelines and best practices

ISO-9001 is the universally-recognised standard for quality management, but when it comes to calibrating your equipment, it can be a little ambiguous. The standard itself makes references to calibration, meaning it is a requirement, but there is a little bit more unpacking required to fully understand how you can ensure your equipment is boosting the performance of your quality systems.

Ensuring that all measuring equipment is calibrated to ISO-9001 standard is of paramount importance for companies set on improving their products to meet the needs of their customers. In most manufacturing arenas, this includes ensuring that products are of high quality, low cost and of immense value to their customers.

Being able to prove this standard of calibration is a non-negotiable for businesses in many industries - as failure to do so can seriously restrict or even destroy their ability to trade.

In this article, we explain what businesses need to do to make sure the calibration of their equipment is watertight - and feeds into an efficacious quality management system. Read on to find out what you need to do to ensure ISO-9001 calibration compliance.

What are ISO-9001’s requirements for calibration? 

For calibration standards that are so important for businesses to meet, ISO-9001’s references to calibration are brief and vague. This is because ISO-9001 is a huge document that sets standards for businesses in all sectors around the world. Only two small clauses of the document are about calibration - hence the lack of detail - but that doesn’t make it any less important for businesses with equipment that needs to achieve high standards of accuracy to adhere to. If you’ve read what ISO-9001 says about calibration, you’ll know that it’s divided into two sections - some general standards, and some pertaining to measurement traceability.

ISO-9001 7.1.5 monitoring and measuring resources

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 the purpose of the monitoring and measurement resources.

Measurement traceability 

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:

• Identified in order to determine their status.
• Safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results.
• 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.

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.

Much of ISO-9001’s discussion of calibration refers to ensuring equipment is up to the standard of the particular industry or application it is used for. In this sense, ISO refers businesses to other measurement standards - on national or international levels - or accepted best practices. Clearly, these will differ from industry to industry. What ISO really requires is measured indicators of quality and processes, to prove accuracy and deal with any quality non-conformity.

This is why ISO-9001’s calibration standards should be viewed as a guiding framework, rather than an exhaustive list of processes that should occur.

Ensuring compliance with ISO-9001 calibration standards

Any business looking to calibrate their equipment to ISO-9001 standards should be aware of the foundations of rigorous calibration. Generally speaking, accurate and up-to-date documentation of the equipment’s calibration status is vital, as well as the intervals equipment should be calibrated between. Processes must also be in place to ensure the equipment’s working environment is regulated to keep the risk of damage or unwanted adjustments to a minimum.

ISO-9001 monitoring & measuring resources checklist

• Determine which resources need accurate results.
• Measure the resources to verify your products or services against required standards.
• Keep documentation of results to monitor progress.

Guidelines for any equipment needing calibration

• Calibrate in set intervals according to required standards.
• Make adjustments according to the manufacturer’s instructions, protecting from unnecessary adjustments.
• Check non ISO-accredited devices against another conforming device for accuracy.
• Clearly document and label with the current status of calibration.
• Consistently protect devices from damage - do not move them during the calibration process.

Ensuring compliance with ISO-9001 calibration standards

As to the specific aspects of the equipment that need to be tested, and to what extent, this will depend on the type of equipment, its uses, and the accuracy requirements of the industry it is used in. The gold standard stipulates what these exact requirements are for a range of industries, but not every piece of equipment requires this level of attention. Some common areas needing particular scrutiny include:

Keeping track of the calibration requirements for every piece of equipment is a painstaking and time-draining process for quality managers. This is especially true for businesses operating a mix of different equipment with different specific calibration needs. It’s because of this that finding a high-quality calibration service provider is the only guaranteed way to easily adhere to ISO-9001.

With laboratories, testing equipment, and engineers accredited to ISO-9001 standard, trustworthy providers offering managed calibration services like DM Systems & Test are best placed to provide the expertise and care needed. Going directly to a high-quality provider also significantly reduces the required downtime of equipment - as they are able to service a business’s entire stock at once to save on time.

Maintaining the highest standards of quality with DM 

With calibration constituting a key part of a business’s quality management system, a trustworthy calibration provider is an ally in helping maintain solid processes. They can ensure all required documentation and protocols around calibration are in place - meaning you don’t have to worry about falling foul of customer expectations or industry regulations.

DM takes care of everything your business needs to comply with ISO-9001’s calibration requirements. We provide mechanical and electrical calibration to both traceable and UKAS standards - and we’ll work closely with you to help you decide which is best for your needs.

Our engineers can calibrate all your business’s equipment at the same time and in the same location to cut downtime to an absolute minimum. Our mobile and laboratory calibration services cover all major tooling and gauges, enabling us to deliver calibration on-site; making it possible to service all your equipment in just a few hours.

To learn more about how we can ensure ISO-compliant calibration that works around your business, get in touch with our team.