ISO Standards

Each sub-division of ISO Standards details how Qualitation can help. Our consultants provide expert support to ensure compliance across the whole range of ISO Standards. They are located around the UK and can work virtually or are prepared to travel far and wide to help transform your business.

ISO standards incorporate best practice from organisations in a wide range of industries and around the globe. There are many benefits to gaining an ISO certificate, including:

  • slashing waste to boost available capital
  • increasing customer retention rates
  • improving workforce morale
  • becoming a leader in your market sector.
ISO 9001 Quality

ISO 9001 is the international standard that specifies requirements for a quality management system. ISO 9001 is the ultimate indicator of quality. Its focus is customer satisfaction.

Organisations use the certification to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
This ISO 9001 quality standard alone, is held globally by more than one million organisations – more than 20 times the number of organisations holding “Investors in People”.

ISO 9001 allows you:
• To match your products or services with your customers’ expectations
• To ensure that you never miss customer preferences as markets evolve
• To enable your organisation, however large or small, to be agile to changes such as market prices

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ISO 14001 Environment

ISO 14001, covering environmental management and monitoring, is the second-most popular standard across the globe after ISO 9001 (quality management system). It’s available to any size of organisation. It’s all about reducing impact on the world around us while maximising the positive effects of your own operations.

ISO 14001 helps businesses across all sectors make their day-to-day activities more sustainable. This covers procurement, storage, distribution, product development and production, manufacturing, marketing and more.

In turn, proven environmental credentials breed many positives, including increased brand advocacy, reputation, employee engagement and, ultimately, sales. According to the British Standards Institute, achieving ISO 14001 certification has led to 60% of companies measuring increased trust from their customer base.

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ISO 45001 Health & Safety

Look after your people and they will look after you

The ISO 45001 certification indicates a safety-first approach and the requirements are, in large part already enforced by legislation. The beauty of ISO 45001 is that it enables any size of organisation, in any industry, to remain compliant in the face of ever-changing health and safety laws. Ultimately, this protects your most valuable asset – people.

ISO 45001 formalises a business’s approach to health and safety using thorough, but efficient, documentation, verified with further checks and balances by a third party. Our Consultants can advise on all aspects of ISO 45001.

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ISO 27001 Data Security

ISO 27001 details how to address concerns about data security – what to do to control the related risks and how to determine improvements while providing appropriate flexible criteria checklists against which to assess the right actions.

We offer both a consultant based approach and a semi-automated approach using the 27K1 programme (with support from Consultants if required) – it depends what you are looking for. This is a quick and simple way to generate your own data security controls based around the ISO 27001 Data Security Standard. 

Designed to address the concerns of data loss, data breach, data theft, data corruption and ransomware, this takes you through a step by step approach to clearly identifying your risks and what you can do to prevent and reduce such events from happening.

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ISO 13485 Medical Devices

ISO 13485 Medical Devices is designed for businesses which provide medical devices and related services (such as maintenance and repair).

Holding this standard demonstrates that you consistently meet both customer and regulatory requirements in your field.

Specifically, the standard relates to you if you’re involved in the design, development, production, installation and servicing of medical devices.


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UKCA/CE Marking for Medical Devices

Prior to Brexit – all electronic equipment sold in the EU (including UK at the time) had to be CE marked.  Following Brexit, this remains true for EU countries. A new regulatory scheme, UKCA (UK Conformity Assessed) will be applied to products being placed on the market in the UK. UKCA marking for medical devices requires a third-party assessment process by a UK Approved Body.

The process of gaining the UKCA and/or CE marking involves a formal application, together with technical specifications and justifications to support the application.  If a product is to be placed on both UK and EU markets, then it will need to be marked with both UKCA and CE marks – each with its respective application.

Our Consultants can help with these processes – usually virtually – often only an hour or so of time.  

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ISO 14791 Medical Risk Management

This standard details terminology, principles and a process for risk management of medical devices, including software when it is used as a medical device and also in-vitro diagnostic medical devices.

The approach described in this document is written to help the makers of medical devices to identify the hazards involved with the medical device, to assess the associated risks, to control these risks, and to check up on those controls subsequently.

The standard’s requirements apply to each part of the life cycle of a medical device. It specifically relates to risks associated with a medical device, such as those linked to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

These processes can also be applied to non medical devices in some jurisdictions and circumstances and can also be used by others involved in the medical device life cycle.

This standard requires manufacturers to create objective criteria for risk acceptability but does not specify acceptable risk levels – which is left to the determination and business judgement of the manufacturer.

Risk management should be an integral part of any quality management system. However, this document does not require the manufacturer to have a formal quality management system in place.

Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.

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ISO 15189 Medical Laboratory Competence and Calibration

ISO 15189 was devised to uphold standards in medical laboratory environments, such as Covid sampling facilities, reflecting the importance of high-quality provision of scientific services as part of the treatment of patients.

ISO 15189 is relevant to businesses in the medical field that rely on taking measurements, conduct regular experiments and assess scientific outcomes relating to their own or other organisations’ operations. It’s also worth considering whether your company is involved in designing, making or selling products to medical firms, as the standard demonstrates reliability in a highly regulated industry.

To achieve ISO 15189 accreditation, organisations must prove:
• Laboratory processes are recorded, controlled and checked for errors
• A regular process audit is in place
• The audit feeds into management reviews.

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ISO 17025 Laboratory Competence and Calibration

There are several requirements for organisations looking to achieve this accreditation. Your processes must follow the Scientific Method and be:

• Recorded
• Repeatable
• Controlled
• Error assessed
• Regularly audited and fed into wider management reviews.

There are wide benefits to achieving ISO 17025 accreditation. These include the ability to demonstrate competent operation and valid results; increase confidence in your work thanks to achieving a globally recognised standard; and the knock-on effect of continuously galvanising co-operation between scientific testing companies around the world.

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ISO/TS 16949 Automotive

ISO/TS 16949 Automotive is designed to be scalable and adaptable and is open to all companies, large and small, who operate within the automotive supply chain, with specific focus when working with sub-contractors.

ISO / TS 16949 Automotive certification is applicable to you if you’re working in the design, development, production, installation or service of automotive-related products. It is often, effectively, a requirement when supplying into this market.

It is similar in content to ISO 9001 Quality, but with variations to match the Automotive industry needs. Therefore its main focus is the setting up of a system that allows you to monitor customer feedback, positive and negative, and ensures you’re working to supply what your customers expect.

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AS 9100, 9110, 9120 Aviation

These are a series of standards specific to the Aviation, Space and Defence industry sectors – three of the most heavily regulated sectors around the globe. Unlike many industries where customer service and quality management systems are paramount, lives are at stake if these types of organisations do not achieve this sector’s version of ISO certification – referred to as AS Standards

The AS standard that you choose to strive for depends on which specific section of these industries your business operates in: Manufacturing (AS9100), Maintenance (AS9110) or Distribution (AS9120).

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There are over 20,000 ISO standards covering areas from how to keep customers happy, to how to erect scaffolding, from how to operate a medical laboratory scientifically to how to determine the exact specification for concrete in different situations.

Many of our consultants cover a number of different ISO Standards and have many years practical experience in wide range of industries – so have a wealth of additional skills to offer.

If you do not find what you are looking for in the list above, please feel free to contact us anyway and we will see if we can find someone who can help you – or at least point you in the right direction.  There is no charge for enquiring!

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