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We have worked with QFactorial for the past year to help us implement the ISO 13485 Medical Devices standard. Although we have experience with several standards the ISO 13845 documentation requirements are much more thorough than that of ISO 9001 for example and also the terminology differs greatly and this set a significant challenge. QFactorial were able to offer a robust gap analysis and synergy tool that helped guide us through the early part of the project, and with Kevin’s auditing of our internal processes we were able to identify and improve any weak areas within our system. Working closely with Kevin Brown has been a real pleasure and with his experience and advice we have been successful in implementing the ISO 13485 standard.
ISO 13485 certification for Covid-19 test kit assembly and distribution
Although we have excellent in-house experience and robust existing systems, we needed some instant consultation on moving up to ISO 13485 and couldn’t risk falling short, so we sought a safe pair of hands to help us get over the line. It was particularly pleasing to achieve the standard with half as many OFIs and NCs as are typical. Without QFactorial we would have had a much-extended process and the flow of PCR tests would have been much reduced. Achieving ISO 13485 certification has enhanced our productivity and increased market interest from clients to support their projects, so money well spent.
Integrated BMS with ISO 9001 and ISO 14001 for chemical distributor
After our ISO manager left the company, we employed the services of Kevin at QFactorial to help us update our onerous and outdated ISO manual. Kevin rewrote our ISO manual into a useable Business Management System, reducing the number of documents substantially and producing a modern, concise system well matched to our business needs. Audits are conducted sensibly, using a common-sense approach to observations and non-conformancies. The feedback provides highlights as well as areas for improvement rather than nit-picking. After we achieved ISO 9001, we decided to go for ISO 14001, and again QFactorial’s experience was invaluable. Even the complex world of environmental legislation was made easy to understand and as a result we have been able to record our environmental impact and demonstrate through our certificate that we are environmentally responsible. We are happy to continue our relationship with QFactorial as consultants to assist us in maintaining our BMS.
Integrated BMS delivers ISO 9001, ISO 14001, ISO 45001 and Achilles UVDB certification
From the outset, QFactorial and Red Penguin have enjoyed a very positive working relationship. Kevin has worked tirelessly, assisting us with re-structuring our Business Management System and in our transfer from OHSAS 18001 to ISO 45001. His guidance and advice were tailored uniquely to our business model and as a result we achieved a 100% score in all three of our ISO certifications and Achilles UVDB, a great outcome after the first eight months’ involvement.
Compliance support for Water Asset Management
Kevin and his team have been working with us since our conception in 2015. QFactorial have come along on our quality journey with us to develop a Quality Management System that is not only compliant but also adds a huge amount of value to our operations - what we can realistically achieve and maintain and also how our team at Veriflo use it as part of their everyday. Without QFactorial's assistance and patience we would not have achieved the successful surveillance audit that we have just had.
Strategic quality review for international oil & gas operator
Quality is carried out in our business in different areas and often in different ways. We invited QFactorial to conduct a diagnostic exercise throughout a number of functions of our business across geographic areas where we operate. At the conclusion of the three-month programme, this has allowed us, for the first time, to obtain a holistic view of how Quality is approached within our business. At the conclusion of the diagnostic phase, QFactorial have proposed eight workstreams as part of a strategic quality management programme and this is now being evaluated.
QA services for a Danish power plant
This was our first project partnering with the Q! Team and it launched and progressed quickly but smoothly, to deliver a very good outcome for the client. Good communication as the project developed and great support throughout, enabled us to adapt and respond to their emerging business needs.
A Hat-Trick of Health & Safety Approvals
In the wake of the publication of ISO 45001, we faced the challenge of three of our long-standing SME clients deciding simultaneously to formalise and improve their existing health and safety (H&S) systems in order to get certified to the new standard. One of these clients, Purple Leisure Services, left us this feedback:
"We initially set up our Quality Manual with the help of Kevin. His balanced and logical approach helped us to produce a Management System which was so robust that the Health and Safety elements then fitted seamlessly into it. We simply worked through our processes, guided by Kevin who helped us to ensure that we had everything covered within the Standard. This therefore meant that the whole process was much quicker than we anticipated and, honestly, pain free."
We worked with Qfactorial to build a robust Business Management System and fast-track our certification for ISO9001 and 13485.
It was a really rewarding process, Qfactorial were able to quickly understand our business and how we work which allowed us to fine tune the output appropriately. Qfactorial then provided the right level of support to help us build a robust Business Management System that reflected our business, helping us to balance the need for documentation and process with the pragmatic requirements of running a creative business.
The process was in depth but also enjoyable, and Qfactorial were incredibly responsive for questions and support.
The result is a BMS that is core to our business and a recommendation for certification for ISO9001 and 13485
We needed a consultant to help us to upgrade our management systems for UKAS-accredited ISO certification. Of those we contacted, QFactorial seemed to best understand our particular needs as a small, fast-growing, fast-changing construction business. Initially we were just focused on quality and ISO 9001, but QFactorial steered us towards a more integrated and business-focused approach. Building on existing processes, and aligning with ongoing initiatives, we worked together to develop a business management system (BMS) that would satisfy ISO 9001: 2015 and be ready for future integration of ISO 45001 and ISO 14001.
We passed both stages of the ISO 9001 audit with zero nonconformities. More importantly, the BMS is a true reflection of how we work and a solid foundation for business growth. They were on hand for continuous advice and were very accepting of our continuous changes and demands as the company rapidly expanded during the process.
We have now engaged QFactorial for the next stage of development of our BMS as we progress towards ISO 45001 certification. We are pleased to be continuing the partnership as we work towards the next milestone.
It was a pleasure working with Kevin Brown of QFactorial and we are happy to recommend his services. Kevin worked in a professional manner that helped guide our company through the transitions required to achieve an effective outcome. His approach to all aspects of our quality management system has contributed to a positive result, which assisted us in achieving and retaining IS0 9001: 2015 and AS 9100 Rev D
We engaged QFactorial to develop a Business Management System (BMS) that was closely aligned to the operational activities and objectives of the company, and that would also embrace all elements of ISO 9001:2015.
Through a series of face-to-face meetings with senior management QFactorial were able to grasp the inner workings of the business and successfully develop the BMS. A step-by-step approach enabled both parties to modify and fine-tune all necessary areas to arrive at the approved system to be adopted.
The outcome was perfect. The new BMS fulfilled the company’s criteria while at the same time it fully complied with the ISO 9001:2015 standard. It was subject to assessment by BSI on 1st August who were happy to confirm all areas were compliant, without issue. QFactorial – a job very well done.
We are very pleased to continue our collaboration with QFactorial, who have been very supportive and flexible to accommodate our requirements into the work necessary to maintain ISO 9001 this year. As an SME, it is important to count on experts, who can bring industry experience, listen and adapt to the changing needs of a fast growing company. Kevin has done precisely that and as a result we have managed to achieve our goal this year with zero audit findings!
QFactorial took our paper-heavy QMS and greatly reduced the amount of bureaucracy by distilling the entire system into one manual, eliminating unnecessary forms and procedures. They guided us through the new requirements of AS 9100 Rev D and ISO 9001:2015, including facilitating a successful certification audit.
QFactorial worked with us stage by stage, establishing a simple roadmap that our people could understand. They managed the development, implementation and audit processes, engaging the staff without imposing too much on too many at any one time.
We passed the audit and achieved ISO 27001 on-time, with a usable system, supporting the business and supporting GDPR. We now use this achievement to provide assurance to our customers that we have robust information security systems in place.
Purple Leisure Services
QFactorial attended and laid out a comprehensive action plan that we would need to complete in order to meet our deadlines. Despite first being quite sceptical that we would be able to achieve everything in the allocated timeframe, we were soon reassured that actually it could be done, and they were with us all the way! By following the new Business Management System that QFactorial helped us to set up, we completely rewrote our entire Quality Manual. It is a testament to the way in which they work that, when I say "re-wrote", we actually halved the content. This has resulted in a manual that people actually use and which they feel ownership of!
Qfactorial provided exactly what we needed as a small consultancy: excellent insight into developing a Business Management System that meets the needs of our business, as well as successfully helping us achieve ISO 9001 certification. Qfactorial didn't just provide something off the shelf, but used an adaptable and flexible approach to shape what we required.
Self Adhesive Supplies
Our consultant, Qfactorial, was instrumental in achieving a smooth transition to ISO9001:2015. A structured and thorough approach to the transition was achieved within 3 months and this included a complete revision of our Quality Manual.
Qfactorial worked with a small team for 12-15 months to improve the quality of complex industrial equipment for a global manufacturer, whilst in parallel developing and deploying a new quality strategy. The great success was simplifying complex situations for the client, providing them with a step by step approach to improve product quality. A robust plan kept everyone on track throughout implementation, working collaboratively with the client team, providing direction, support and drive. As an example of the benefits achieved, an initial focus on the quality of the assembled product reduced the number of non-conformities per product from 14 to less than 3 in the first four months, preventing more than 500 quality escapes in this period.
Qfactorial have been working with us for several months now and I cannot praise them enough. Apart from being very easy to work with, they have got to grips with our business (contract catering), totally rewritten our BMS manual to meet the new standard, which was a daunting task for us, and also helped with our recent ISO audit, which we passed with flying colours. Qfactorial's work on our ISO 9001, 14001 and 50001 certifications has made a significant difference to our company and I would have no hesitation in recommending Qfactorial to other companies.
We worked together on the definition and implementation of supply chain management systems and processes for a large multinational company. Vast experience of management systems, quality assurance/ control and engineering processes made Qfactorial a perfect fit for the role. In particular, the approach to understanding the issues faced by the organisation and implementing practical solutions was fundamental to the success of the project.
Qfactorial helped Petrofac develop methodology to assess the maturity of our work-share processes. Unlike conventional auditing, Work-Share assessment measures the maturity of the work process governing leadership, communication, systems, people, culture, performance and productivity.
As an output from this initiative, Qfactorial produced a procedure and checklist to define the Work-Share process and assess its effectiveness on projects. The assessment process has drawn noteworthy recognition from LRQA who considered this to be a best practice approach in the Oil and Gas sector.
I have known Kevin since 2008 and have had the pleasure of working with him on development of management system documentation and in auditing. Kevin is very accurate in all his work. He is producing well thought of and comprehensive systems. He performs audit in a pleasant way and at the same time in a motivating manner that is benefiting the organisation. The audit reporting is very clear and it is easy to understand his findings. He has also a good understanding of priorities in the organisation and will focus on these topics during the audit process for the benefit of the company.
There's a method to what we do
There are a lot of management system consultants. So why choose us? We think about every project in a structured way, regardless of size, scope, duration or budget. Find out more about how we work.