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SouthWestSensor ISO 9001 and ISO 14001 for tech start-up
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Elgin Energy UK solar energy developer and asset manager
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Eseye ISO 27001: 2022 Transition for IoT Services Provider

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ISO Standards

Isn’t it aMAZEing?

Despite all efforts from the quality community to convince you that you need one (or more) standards to improve your business, we have found the main driver is more the insistance of a bigger fish somewhere in your market. As much as we would love you to come on the ISO journey with us out of sheer altruism, we do understand that it’s far more likely that you’ve arrived at the decision in order to unlock new markets, become more competitive or a customer/partner requires it of you. 

Of course, the spin off is that it does, in fact, improve your business. With an ISO in place you’ll find yourself more resilient, better poised to take advantage of all available markets, more efficient and with a better understanding of how your business works - and doesn’t work. 

Working with QFactorial means you get a partner with years of experience with these standards and the process of achieving them. We know what the auditors want to see in each case and we also know how to make the standard work for you without introducing swathes of bureaucracy and paperwork. It should be a part of your natural growth, it should make sense to your people and it should be a seamless integration. This doesn’t mean we won’t challenge you - it’s our job to tease out any underlying issues and listen to your current objectives and then make sure that the standard works to truly address these and help you meet your goals. 

And of course, we’re here for as little or as long as you need us for. If you want some help maintaining your shiny new certification, we can do that. If you want to branch out into a new market or a new standard, we can help weave these into your existing management systems, synching them efficiently to avoid unnecessary duplication. If you acquire a new business (or are acquired) we can move with you and integrate all the moving parts. 

We have a wide-ranging team full of different specialisms, locations and experiences, this means we can be on hand no matter what road you go down. Collectively, we’ve seen a huge amount of different businesses in so many varied and interesting sectors - all that knowledge and experience is shared for the benefit of consultants and customers alike. We may be able to offer fresh perspectives or alternative methods that a pigeon-holed consultant might never have seen. With such a great team on board, should your nominated consultant go down with an emergency, there’s always someone else who can take over the reins and keep the project running smoothly. 

So if you’re standing at the entrance to the ISO maze, let us be your guide. We promise you won’t get lost.

Q!Standards

ISO 9001 is an internationally recognised standard with all the kudos and clout that comes along with it. It can be used for all kinds of organisation, no matter your industry or service, and is as applicable to start-ups and micro businesses as it is to large corporate entities and everyone in between. By providing a framework for your Quality Management System (QMS), it will bring structure, process, and consistency to the way you work. QFactorial can ensure the standard bends and fits to the way you actually do business. We'll develop your QMS, together, to improve the quality of your products, services, projects and operations and top it all off with a certification at the end to prove it.

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ISO 13485 is an internationally recognised standard which sets out the requirements for a quality management system specifically oriented towards the highly regulated medical devices sector. The standard can be used by organisations throughout the supply chain, from design and development, to manufacture, import, logistics, installation and servicing, through to end-of-life decommissioning and disposal. The overall objective of the standard is to ensure patient safety.

We can help you to establish, implement and improve your quality management system and make it both compliant and effective. Whether you are establishing a QMS for the first time, or building on an existing ISO 9001 certification, or you just want to make it all work more effectively and get your system certified, we can help you.

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ISO 14001 is an internationally recognised standard for environmental management systems and provides guidance towards implementing a systematic approach for environmental protection.

Unless you’ve been living under a rock for the last decade or so, you’ll know as well as us that climate, environment, and sustainability are all becoming increasingly important to businesses and consumers. With the world’s focus set on tackling the Climate Crisis, customers, investors, governments, businesses, and stakeholders are beginning to make demands that organisations can clearly demonstrate their steps toward operating a sustainable concern. Impending legislation over Environmental & Social Governance (ESG) is only making these calls louder and more insistent.

Implementing ISO 14001 in your organisation can help formalise and develop your approach for tackling these demands. It can help you consider all aspects of your activities to reduce their impacts on the environment. We can help you to establish, implement and maintain an effective Environmental Management System (EMS) and support you in continuous improvement initiatives. Together, we can achieve and maintain your certification.

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ISO 15189 is an internationally recognised standard for quality and competence in medical laboratories. The 2022 edition fully incorporates ISO 22870 Point of Care Testing (POCT). Patient welfare is absolutely the focus of the updates, with management of risk and opportunities for improvement at the heart whilst maintaining many of the previous requirements for the standard. 

There are tens of thousands of medical tests carried out every day across the UK to support health services, diagnostics and treatment monitoring, and each test is of the utmost importance to the patient and their medical team. ISO 15189 now has an increased focus on the well-being of these patients. Their safety and rights during the process have now been aligned with other relevant medical ISO standards to build a robust testing environment. The new revision sets out the core requirements for ensuring quality and competence, patient-centred care, and the obligations of health care providers, and an ethical governance environment.   

We can help you to establish and implement a compliant and effective management system for your medical laboratory, either for the first time or by working with you to transition to the latest requirements. We can help you to achieve and maintain your accreditation - and to continually improve your system. 

 

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ISO 17025 is an internationally recognised standard for the management of testing and calibration laboratories.  It enables laboratories across a wide range of sectors to demonstrate that they are competent, that the results they generate are reliable and accurate.  

We can help you to establish and implement your laboratory quality management system, either from scratch or by formalising and organising processes you already have in place. Together we can make sure you gain (and/or retain) your ISO 17025 accreditation. 

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ISO 27001 is an internationally recognised standard for information security (InfoSec) management, incorporating data management, cybersecurity, and privacy protection. It defines the requirements for an effective system that can be applied to any type and size of organisation. It’s not just for the IT Crowd. We can help you to establish and implement your information security management system (ISMS), either from scratch or by transitioning to the latest requirements, making sure you gain (and/or retain) your ISO 27001 certification.

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ISO 42001 is the first international standard for AI management systems (AIMS?) and provides a framework for managing the risks and impacts associated with developing and using AI technologies. We’d like to think that ISO have been deliberately holding back the number ‘42001’ for an appropriate topic of which Douglas Adams would approve. It defines the requirements for an effective system that can be applied to any type and size of organisation. It’s not just for the IT Crowd.

We’ve all watched enough sci-fi by now to have a healthy fear of the implications of AI, and we’re not saying Terminator wouldn’t have happened if they’d have had ISO 42001, but Skynet might have at least had a roll back plan….

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ISO 45001 integrates health and safety compliance into your business processes, encouraging everyone to take responsibility for health and safety in their day-to-day behaviours and decision-making. Your HSMS will demonstrate compliance and commitment to all stakeholders. 

ISO 50001 is an internationally recognised standard for energy management systems. It provides guidance for organisations to establish a recognised and structured approach for energy performance improvement, incorporating consideration of energy efficiency, energy usage and consumption.

Across the world there is an increasing awareness of the issues around energy, its generation, transmission, usage, and the impacts on security of supply, the needs for increased efficiency and what the future challenges and developments will be. Increasingly customers, investors, governments, and other stakeholders are requiring the organisations they deal with to take clear and effective steps to demonstrate continual improvement in their energy performance, with clear energy objectives that are measured, and clear fulfilment of their legal and regulatory compliance obligations.   

Implementing ISO 50001 in your organisation will help you to take the structured steps you need to determine how to organise, operate, measure, verify and improve in managing energy performance associated with your organisation.  It can help you to formalise and develop your own approach and to consider all the aspects of your activities, and since the standard now aligns with the ISO management systems structure, it can be integrated with other management systems standards such as ISO 9001 and ISO 14001. We can help you to establish and implement an effective Energy Management System (EnMS). We can support and help you to develop and continually improve your system, and to achieve and maintain your certification.

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ISO 55001 is a standard which provides a framework to help organisations to manage their assets more effectively across their complete life cycle from acquisition to decommissioning. Implementing a system complaint with ISO 55001 can help you to manage the risks and costs associated with the assets of your organisation, enable you to meet your stakeholder, business and legal requirements, and to support on-going value creation and continual improvement. The standard is applicable to all types of assets and all types and sizes of organisation. If asset management is important to the delivery of your products and services, or if your organisation manages assets on behalf of others then ISO 55001 could be for you.  

We can help you to establish and implement an effective asset management system, either from scratch or by working with you to build on your existing processes. We can help you to maintain and continually improve your system –and to achieve certification if required.   

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AS9100 is a quality management standard which is widely adopted by the aerospace, space and defence industry worldwide. It’s latest issue – revision D – was released in 2016 and is based around ISO 9001: 2015. It adds industry-specific quality management requirements applicable throughout the aerospace supply chain for organisations that design, develop or provide products or services. AS9100 was prepared by the International Aerospace Quality Group (IAQG) and is recognised throughout the industry in challenging and highly regulated sectors.

In addition to the general aerospace standard AS9100 the IAQG created AS9120 specifically for the quality management of stockist distributors.

We can help you to establish, implement and improve an effective quality management system compliant with AS9100. Many aerospace manufacturers and supply chain members will only work with partners who hold certification. Whether you are establishing an AS9100 compliant system for the first time, or you just want to make your existing system work more effectively, we can help you through the complete process.

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QFactorial have been working with us since 2016 and I cannot praise them enough .... QFactorial's work on our ISO 9001, ISO 14001, ISO 45001 and ISO 50001 certifications has made a significant difference to our company and I would have no hesitation in recommending QFactorial to other companies.

Kim Lovelock

Regional Operations Director, Connect Catering

Case Study:
Connect Catering ISO 9001, 14001, 45001 and 50001 for catering services
Nouveau Solutions ISO 27001 Information Security for Managed IT Services
Aerocomponents AS 9100 Rev D for aerospace and F1 manufacturer
Biopharma Process Systems ISO 13485 certification for Covid-19 test kit assembly and distribution
ISO 17025, ISO 15189 and ISO 22870 accreditation for Lord’s Pharmacy UKAS Stage 3 documentation for Covid-19 swab sampling, followed by scope extension to include rapid antigen lateral flow testing
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