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FAQ

Question 41.4 Accreditation scope for ISO 19443

Scope of accreditation for ISO 19443 (Quality management systems – Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS))

In the case of granting accreditation according to ISO/IEC 17021-1 for ITNS. What is your opinion?

1) Is it necessary to grant accreditation to ISO 19443 together with ISO 9001?
2) Shall the scope of accreditation according to ISO 19443 be described by technological sector(s) e.g. as description of economic sector / activity in the IAF ID 1:2020?

March 2021

1) Is it necessary to grant accreditation to ISO 19443 together with ISO 9001?

Answer is NO

Accreditation for certification to ISO 19443 shall use ISO/TS 23406 (Nuclear sector — Requirements for bodies providing audit and certification of quality management systems for organizations supplying products and services important to nuclear safety (ITNS)) as a lever for normative document, in addition to ISO/IEC 17021-1.

ISO/TS 23406 specifies all requirements, including those relating to multisite and audit duration. Therefore, there is no need to have a combined accreditation for ISO 19443 and ISO 9001 EA code 11.

Furthermore, accreditation for ISO19443 shall not automatically imply an accreditation for ISO 9001:  for accrediting the CB for ISO 9001 it shall be verified that it has considered the specific documents (i.e., IAF MDs) and have implemented them correctly. For instance, regarding the audit duration, the determination of the effective number of personnel is different for ISO 19443 certification purposes than for ISO 9001.

Another point is that an organization applying for a combined certification ISO 19443 and ISO 9001 would not necessarily, for ISO 9001, fall under EA/IAF code 11 as it could be operating in other codes (17, 18…) depending on its activities.

2) Shall the scope of accreditation according to ISO 19443 be described by technological sector(s) e.g. as description of economic sector / activity in the IAF ID 1:2020?

Answer is NO.

Consistency implies that we stay with the same level of detail than an  EA/IAF code which is the 11 in this case.

The “Table A.2 — Typical technological sector(s)” of ISO/TS 23406 describes technological sectors.

It can be used by the CB as a guidance to determine the competence of the auditors to justify the criteria “Understanding of the nuclear industry and familiar with nuclear safety culture and knowledge of clients technological sector”. This table A.2 lists the more common technological sectors in the nuclear industry and this list is not exhaustive. This information is for the CB only to help it with its personnel qualification.

The accreditation scope will be ISO 19443 standard.