Shall Notify Body follows the relevant MD IAF documents when they are assessing Manufacturer quality system (i.e. Conformity to EU-type based on quality assurance of the production process – Module D)?
Shall in particular be considered mandatory the followed documents: IAF MD5 (duration of audit), MD2 (transfer of certification), MD1 (multiple sites sampling)?
September 2018
As in the example given in the question:
(In Blue Guide 2016)
D Conformity to EU-type based on quality assurance of the production process
Covers production and follows module B. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU- type. The notified body assesses the quality system.
Module Description EN/ISO/IEC 17065 EN/ISO/IEC 17020 EN/ISO/IEC 17021 EN/ISO/IEC 17025 D Conformity to type based on quality assurance of the production process 1 + qa 1 + qa 1 + pk qa: Ability to assess and approve manufacturer’s quality systems where required. To this end, fulfillment of clause 9 in EN ISO/IEC 17021:2011 shall be demonstrated.
pk: Ability to make professional judgments related to product requirements where required. To this end fulfilment of clauses 6.1.2, 6.1.3 and 6.1.6 to 6.1.10 in EN ISO/IEC 17020:2012 shall be demonstrated.
Also, for Module D (Conformity to EU-type based on quality assurance of the production process) ISO/IEC 17065 is preferred standard.
In ISO/IEC 17065:2012
6.2.1 Internal resources
When a certification body performs evaluation activities, either with its internal resources or with other resources under its direct control, it shall meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents. For testing, it shall meet the applicable requirements of ISO/IEC 17025; for inspection, it shall meet the applicable requirements of ISO/IEC 17020; and for management system auditing, it shall meet the applicable requirements of ISO/IEC 17021. The impartiality requirements of the evaluation personnel stipulated in the relevant standard shall always be applicable.
NOTE Examples of reasons as to why some requirements are not applicable include the following:
- expertise is available within the certification body when using the results of the evaluation activity;
- the extent of control the certification body has over testing (including witnessing the testing), inspection (e.g. specifying inspection methods or parameters) or management system assessment (e.g. requiring specific details of a management system);
- a particular requirement is covered in an equivalent way by this International Standard, or is not needed to give confidence in the certification decision.
It can be noticed from above definitions and requirements, there is a strong link between accreditation for notification purposes for quality management system-based modules and accreditation requirements for MS certification bodies. In almost all cases, it is appropriate for Notified Bodies to take into account the relevant MD IAF documents while assessing quality management system-based modules e.g. Modules D, E, H and their derivatives, especially IAF MD5 (duration of audit), MD2 (transfer of certification), MD1 (multiple sites sampling), or the Notified Bodies should take applicable IAF MDs as reference in relevant issues i.e. audit or evaluation time allocation, multi-site sampling and transfer of certification.