Which standards apply to your electrical and mechanical test equipment?

Different systems of quality management apply to different industry sectors, which means distinct calibration standards are required. For some industries, such as aerospace, medical devices or automotive engineering, trade bodies set the standards for calibration. For others, the regulation is less stringent and relies on companies to maintain appropriate levels of quality management.

Quality management systems are key to ensuring consistency across products or services. Achieving specific quality management certification demonstrates to customers and stakeholders that you, as an organisation, value continuous improvement and are committed to quality control.

Many quality control accreditations focus on the organisation as a whole, covering areas such as leadership and employee engagement. They also look at how your organisation interacts with others, the business’s customer focus and your relationships with clients and retailers. They analyse your processes; from how departments interact with each other, to how you make decisions, and finally, to how you consistently provide a high-quality product or service.

The importance of calibration for an effective quality control department

Quality control departments should have systems in place to ensure that equipment used for measuring is accurate and reliable. Whether you’re using a voltmeter in electrical systems, or geometrical measuring devices, you need to know that the instrument you’re using is working correctly so that you can trust the results are accurate and reliable.

Calibration is key across various departments of an organisation, from research and product development through to shop-floor manufacturing. Many components are produced with tight specifications that are critical to the operation, quality, and safety of the device. This can have a knock-on effect on a company’s revenue, as positive experiences from high-quality products will generate further business and a loyal customer base. High standards of calibration throughout a manufacturing process will also reduce the number of production errors and recalls of the final product, saving the organisation money in the long term.

Which standards exist?

The most widely recognised quality management certification is ISO 9001. This is a standard that can be applied to any organisation, no matter which industry sector they operate in. ISO 9001 looks at quality control methods across all departments, ensuring they understand, implement, and maintain quality standards.

Clause 7.15 of ISO 9001:2015 specifically looks at calibration and outlines the requirements that should be followed. It recommends that instruments are fully calibrated according to manufacturer instructions before first use. Subsequent calibrations should also be carried out according to manufacturer guidelines but considering the frequency of use. This is similar to car servicing requirements that are carried out after a set period or a given mileage.

ISO 9001 requires quality control departments to maintain records of calibration for future reference and auditing. This should include the device name or reference number, parameters calibrated, acceptance range or tolerance levels and the date of calibration. Many organisations use calibration tags or stickers to notify the operator of the calibration status of the measuring apparatus, much like the labels applied to equipment that has passed portable appliance testing (PAT).

Finally, many companies use an ISO 17025 accredited laboratory to carry out external calibration. ISO 17025 is a separate standard for calibration laboratories which has similar criteria to ISO 9001 but some additional clauses. These clauses cover competence, impartiality, and consistency of testing.

Industry-specific standards and regulations

Some industries have extra quality control standards, such as aerospace, medical devices, and the automotive industry. These industries operate within tight quality parameters because inaccuracies and component failures can have serious safety implications.

AS9100 is a certification requirement for the aviation, space, and defence industries. It must be implemented by organisations who design, develop and manufacture aerospace products, but it also affects the supply chain in this industry. It incorporates all of the regulations detailed in ISO 9001, but with further clauses relating to safety and quality.

Medical devices are covered by the Medicines and Healthcare products Regulatory Agency (MHRA). This is the regulatory body that registers and certifies devices suitable for medical use before they can be made available on the British market. Manufacturers must adhere to additional safety and cleanliness measures during processing and commit to reporting incidents once the product has gone to market. Medical devices also come under ISO 13485 standards.

The automotive industry is regulated by a set of standards that are also based on ISO 9001. This was developed by the International Automotive Task Force (ITAF) and the current version is IATF 16949:2016. It includes customer specific requirements that apply to the automotive sector and applies to organisations that manufacture components for supply to the automotive industry.

Choosing the right calibration service

Depending on which industry sector you operate in, calibration requirements can vary considerably. Some will require UKAS calibration or using ISO 17025 accredited laboratories. Others will require traceable calibration as a minimum. D + M Systems & Test can offer a choice of standards for calibration. To find out more about the different levels of calibration that we offer, read our UKAS vs Traceable Calibration Guide.