This may be demonstrated through: (a)Pr
oduct certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either:accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), orable to demonstrate competence by other means
in accordance with Sections A and B of the Annex to this Agreement (b)Quality System certification bodies
operating according to the requirements of EN 45012 or ISO Guide 62, and either:accredited by JAS-ANZ, or
...[+++]able to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement (c)Inspection bodies operating according to the requirements of ISO/IEC 17020, and either:accredited by the Testing Laboratory Registration Council of New Zealand or any other body established by law in New Zealand which replaces it and which has the same functions, orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.