Richard Shearwood-Porter of The HSQE Department provides an insight into the steps towards achieving ISO 19443.
Major accidents in the nuclear sector are rare but, when they do happen, the consequences are enormous and long-lived, which is why the nuclear industry is highly regulated and completely focused on doing things “right first time – every time”. Those already working with the nuclear industry know that this extends to the safety and quality requirements of entities that supply products and services important to nuclear safety.
The nuclear industry has found that companies that produce equipment, systems and services for it need quality management systems that go beyond ISO 9001, with the main focus being on “designing safety in”. This is the thinking behind ISO 19443, which was released in 2018. ISO 19443 was developed by 24 international experts, working closely with the International Atomic Energy Agency (IAEA). The committee started with the well-known quality management standard ISO 9001, to which 1 million organisations, in 170 countries around the world are certified, and tailored it for use by the nuclear supply chain. The new standard is supplementary to ISO 9001, but doesn’t replace it.
What does ISO 19443 do?
ISO 19443 aims to:
Develop a high level of nuclear safety and quality culture, at all levels;
- standardise quality & management systems to the greatest extent possible throughout the supply chain;
- improve quality, lead-time and cost by achieving a clear understanding of requirements in the supply chain and by wider application of good practices;
- ensure suppliers provide the appropriate level of quality in the delivery of products & services, which meet the client’s expectations and comply with the regulations that apply;
- and contribute to operational excellence by supporting continuous improvement initiatives that may be needed to reach the expected quality level.
ISO 19443 is written to be generic, so that it can be used at all levels of the supply chain, for any product or service with the potential to affect nuclear safety, and by organisations around the world.
How do I go about it?
If you already have ISO 9001, ISO 19433:2018 can take your quality management system to the next level. When you embark on a project to implement ISO 19443 you’re making some important commitments:
- To identify and comply with all of the legislation and other key requirements, such as industry codes of practice, which apply to your business
- To identify the significant safety hazards that your product or service presents; then to design out the hazards to the greatest possible extent
- To continuously improve your quality & safety performance
Most well-run organisations in the nuclear supply chain will already have many elements needed to conform to ISO 19443 and a skilled practitioner can take what an organisation does and demonstrate how it meets the standard, rather than having to write completely new processes from scratch. This avoids the need for employees to learn new ways of working and cuts down the time needed for implementation.
The first steps towards ISO 19443 involve a systematic assessment of the organisation’s quality management system and the control measures that it has already put in place. This is followed by a searching look at the legislation that applies and evidence that the company is compliant. It is at this early stage in the process, known as a “gap analysis”, that even quality & safety conscious companies find areas that they’ve overlooked and start to realise the benefits of the standard.
Once all of the “gaps” have been filled and your ISO 19443 nuclear quality management system is operating smoothly, this is the time to call in a UKAS accredited certification body. Certification follows two stages. Stage 1 is a mainly desk-based review of documents, procedures & records, to test whether all of the clauses of ISO 19443 have been met. This is followed by a short period of time during which any weaknesses in are put right. Stage 2 is a more in-depth audit that checks whether the quality management system is working in practise. All being well, the certification body will tell you, at the end of Stage 2, whether they are recommending you for certification. Your ISO 19443 certificate will arrive a few weeks later.
The United Kingdom Accreditation Service, UKAS, is currently working with UK certification bodies to qualify them for certification of ISO 19443.
How can I get advice?
The HSQE Department Ltd has years of experience helping companies to implement ISO management systems and so can reduce the time and cost needed to achieve certification. We can carry out gap analyses to identify what you need to do to comply with ISO 19443, help you to define a plan to implement any changes, guide the preparation of the nuclear Quality Management System, carry out pre-certification checks on the compliance of your systems and manage the certification visit.