N0200R0

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SKN_N0200R0
Proposal for Resolution including new ANNEX E for FPC and ISO 9001 requirements covering
production line
Introduction
Our Specific Rules specify that ‘’the manufacturer shall operate a quality system covering the
production line of the product for with the licence to use the KEYMARK is granted…of the level
of the ISO 9000 standards’’
As certification bodies and inspector bodies have started meeting in order to harmonize their
procedures, we have discovered that FPC and ISO 9001 requirements are not being treated
exactly in the same way. All certification and inspection procedures are being complied with,
but perhaps lacking a higher level of harmonization.
The future version of EN 12795 will incorporate a more detailed clause on factory production
control.
Therefore an annex that clearly specifies what ISO 9001 requirements must be dealt with, and
at the same time specifies more clearly through tables what FPC requirements shall be
required, will be helpful for all parties in the certification process.
As the Keymark grows into a larger family, clearly specifying these requirements will be very
helpful in harmonizing procedures for all parties involved.
This annex is based on the draft of the clause for FPC for the next version of EN 12975, and on
already existing FPC requirements on different product standards: EN 13172 (thermal
insulation products) and EN 1279-6 (insulating glass units).
Members of the working group for this annex are: Alberto Garcia de Jalon, Carsten Lampe,
Christian Stadler, Francois Xavier Ball, Franz Helminger, Henry Rosik, Jaime Fernandez, Ralf
Koebbemann-Rengers, Reuven Godali, Stefan Mehnert, Stephan Fischer, Ulrich Fritzsche and
Wolfgang Eisenmann.
New items with respect to actual Insepction check list
The purpose is not to add new requirements, but to specify those that are already being
complied with.
The differences with respect to requirements on our inspection list are:

The following items regarding ISO 9001 standard have been added (and adapted)
Item on annex E
2.2 Responsibility and authority
2.3 Management representative for factory
production control
2.4 Quality Objectives
2.5 Management review
2.6 Training of personnel
Item on ISO 9001
6.2 Human resources
5.5.2 Representative of management
5.4.1 Quality Objectives
5.6 Management review
6.2 Human resources
3 Quality Manual
6 Handling, storage, packaging and marking of
products
7 Traceability of products
8 Internal audit


4.2.2 Quality manual
7.5.5 Preservation of product
7.5.5 Preservation of product
8.2.2 Internal audit
Tables regarding controls done by the manufacturer on incoming goods and on
products, during and after, the production process have been added
Throughout the annex all new requirements from FPC on draft of new version of EN
12975 have been added
Proposal for Resolution
In clause 5 Factory production control and initial inspection of manufacturing site
Change:
The quality management system shall cover the production line according to inspectors
criteria.
For :
The quality management system shall cover the production line according to inspectors
criteria. In the case of collectors, the requirements are specified in Annex E
Add a new Annex E, Factory Production Control and ISO 9001 requirements covering the
production line which is defined in attached document SKN n0178 R5
The factory production must comply at least with the requirements established in ANNEX E.
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