NQSA promotes the use of the ISO 19443 standard

ISO 19443

2018 adds requirements to those specified in ISO 9001: 2015 and offers an organization the opportunity to introduce some additional features to its quality management system (QMS). The regular QMS standard, ISO 9001, has some 400 requirements specified. ISO 19443 adds another 200 plus to the standard to meet the expectations of licensed operators in the nuclear sector. It specifies requirements for a quality management system when an organization :

needs to demonstrate its ability to consistently provide products and services important to nuclear safety that meet both customer requirements and applicable statutory and regulatory requirements

aims to enhance customer satisfaction through the effective application of its quality management system, including processes for systematic improvement and quality assurance.

All the requirements of ISO 19443 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides to the nuclear sector. The new standard is likely to appeal to companies that supply items important for safety to customers from non-nuclear industries as well as to established suppliers to reactor vendors and licensed nuclear operators. Such companies will often already have a QMS that goes well beyond meeting the requirements of ISO 9001. For example, the aircraft sector has additional QMS requirements similar to those described in ISO 19443.

The standard also aims to meet the General Safety Requirements for Leadership and Management for Safety issued by the International Atomic Energy Agency in 2016 (IAEA GSR Part 2), which are the foundation for many countries’ regulations on nuclear safety. ISO 19443 includes the following nuclear sector specific requirements

Maintain a quality manual or quality plan (this requirement is no longer mandated by ISO 9001, by the way).

Ensure that top management take nuclear safety into account in decision making.
Provide the resources to ensure that nuclear safety is not compromised.
Ensure an appropriate nuclear safety culture and that nuclear safety receives the attention warranted by its significance.
Grade the application of QMS requirements according the licensee’s safety classification of structures, systems and components.
Train personnel on the importance of their tasks in the realization of products and services important for nuclear safety (ITNS).
Ensure persons doing the work are competent on the basis of appropriate education, training, experience and qualification;
Control documented information to ensure it is traceable and authenticated.
Take account of interfaces in design, development and operational planning and control.
Demonstrate that design tools are fit for purpose.
Verify and validate the design and development of products and services using competent persons different from those who performed the design.

Ensure that design and development outputs specify the conditions under which commercial grade items or activities can be used as ITNS items or activities.
Communicate relevant requirements to all levels of the supply chain.
Provide evidence that all production and monitoring/measuring activities have been completed as planned to demonstrate the conformity of products and services to their requirements.
Take account of the range and accuracy of measuring equipment when verifying the conformity of products and services to specification.
Prevent counterfeit, fraudulent and suspect items at all levels of operation.
Report non-conformances and corrective actions without undue delay to the relevant level of management and, as appropriate, to the customer.

Take action to contain the effect of non-conformity on other processes or products.

Undertake root cause analysis, as applicable, to ensure that a non-conformity does not recur or occur elsewhere.

Review the QMS regularly and take into consideration opportunities for improvement, including lessons from nuclear experience.

Share relevant learning from experience with the supply chain.