Calibration of equipment in ISO 13485 and ISO 9001

Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure the equipment you’re using to monitor and measure is giving you consistent results? The answer lies in your calibration process.

Over time, any equipment used in product development and manufacturing can be prone to ‘drift’. Measuring equipment is no exception. Settings and configurations can slip because of mishandling, misuse, atmospheric changes, as well as natural wear and tear. A calibration process ensures you are regularly checking your equipment is delivering consistent and accurate results.

Why is calibration so important?

Even the tiniest change in tolerances can lead to products that don’t work properly. Where equipment is complex and safety-critical, such as medical devices or EV components, even micro-deviations can result in product failure, injury or death. Accurate measurements ensure products are being manufactured to exact specifications, so they will function exactly as intended.

What kind of equipment needs to be calibrated?

  • R&D test & measuring equipment
  • Production line test & measuring equipment
  • Software used for the monitoring and measurement of requirements

Regular calibration is a requirement of ISO 13485 and ISO 9001

Where consistency and precision in quality assurance is an absolute requirement, your calibration regime must be formalised to avoid mistakes, waste and potential harm to users.

That’s why documenting and implementing an ongoing calibration process for your monitoring and measurement equipment is a requirement of the quality standards ISO 13485 and ISO 9001.

Download our complete guide to medical device developmentEquipment calibration in ISO 13485

In ISO 13485 the regulation says

“The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

The organization shall document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.”

Equipment calibration in ISO 9001

ISO 9001 speaks about the importance of documentation in measurement traceability

“When measurement traceability is a requirement or is considered by the organization 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;”

What is the procedure for calibrating equipment?

With this in mind, you need a documented calibration process to:

  •  Identify which equipment needs calibration to ensure required quality in your end product.
  • Determine measurements to be made and tolerances for each.
  • Ensure calibration responsibilities (both internal and 3rd party) are well understood.
  • Calibrate at required intervals and to national and international standards. (e.g. ILAB, NAMAS, NIST).
  • Keep calibration records up-to-date and ready for audit.
  • Adjust or repair instruments where appropriate.

How frequently should you calibrate your equipment?

This is going to depend on the tendency of your equipment to go off-calibration, and the potential risk involved to quality when it does so. But it is influenced by a number of factors:

  • Whether it’s an in-house or external calibration program.
  • The calibration regime recommended by the manufacturer.
  • Usage of the instrument.
  • Behaviour of the instrument (e.g. is it frequently out-of-tolerance?).
  • Accuracy and precision requirements (what tolerances are permitted).
  • Environmental conditions (humidity/temperature etc).
  • Your overall calibration program and policy.
  • Unscheduled calibration due to accident or mishandling leading to non-conformance.

Who is responsible for calibration?

The quality, lab, or production manager is typically responsible for calibration. But it is best to assign a single person to keep an overview, even if detailed activities are delegated. This will ensure you have an identified stakeholder responsible for meeting regulatory requirements and collating records.

For items used off-site (e.g. remote sites, contract manufacturers, etc) you need to ensure that responsibility for calibration is agreed - while gathering evidence that procedures are being followed.

Those who use the equipment are also responsible for checking that it is in calibration when they use it (this will act as a further safety net beyond regular checks).

What to do if something is found to be out of calibration?

  • Advise the ‘owner’/user of that piece of equipment of the calibration failure.
  • Analyse the potential consequences of the calibration fail, including whether the validity of measurements taken recently by that equipment has been compromised.
  • Take corrective actions where necessary (e.g. re-test, add additional tests or inspections, do rework, recall products, advise customers, etc.)

A short guide to non-conformance reports: what, why and how?

9 tips to build an effective calibration process

1. Keep records in a single database

Keep a complete record of all equipment to be calibrated within a single database or equipment log. Look for a document management system (DMS) to compile and control this list.

2. Create documented SOPs

Provide documented SOPs for calibration that people can follow consistently - make them digital, graphical, and accessible for best results.

3. Define responsibilities

Ensure calibration is done by those with authority and competence to do so - ensure roles and responsibilities are clearly defined across your organisation.

4. Keep full calibration records

These can be paper or electronic e.g. scanned certificates, but a digital system is easier and less cumbersome to store and maintain. A dedicated document management system will also help you with version control and document integrity to ensure accuracy. Look for a system that allows you to create bespoke forms, to capture the unique flow of your calibration process.

5. Automate reminders

Have a process for flagging calibration due dates in advance - a digital and automated system of notifications is less likely to result in missed reminders and process failures.

6. Keep calibration status obvious

Have a way of easily, clearly and visually confirming the calibration status and next due date for each piece of equipment - at point of use. You can label machinery and use QR or reference codes to link users to records within your QMS for more information.

7. Mitigate risk of mistakes

Ensure the equipment cannot be adjusted, damaged or suffer from deterioration, without this being obvious. Create procedures to shut down and store equipment consistently when idle.

8. Incorporate visual checks

Have a regular visual ‘sweep’ through all areas of the business for equipment that is out of calibration or that will need it imminently, as well as damage or tampering.

9. Trigger non-conformance reports and CAPAs

Ensure you have a system to trigger non-conformance and corrective action processes when necessary. Use a DMS that can automate your workflows and reduce the risk of omissions and mistakes in your process.

Calibration is an essential part of quality management. The accuracy and consistency of calibration directly impact the quality of products produced. Quality managers must be able to accurately monitor the calibration of equipment in order to ensure that their products are consistently made with the highest degree of accuracy, efficiency, and reliability.

Calibrating equipment regularly also allows for potential problems to be identified quickly before they become a larger issue, allowing for greater control over cost, production standards, and customer satisfaction.

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Tags: Quality Management System, Compliance

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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