Interpretations related to JIS Mark scheme

JIS Certification Bodies Association

This translation has been made based on the original collections of the interpretation by JISCBA

March 29, 2013

[Common 15] Handling of on-site audit and the content of the product test when adding"Factory or business site" that has already received the certification of thesame JIS to the JIS certification (Assumption of the factory to be added:
Factory that is responsible for the process representing that of licensee to beadded).

Interpretation:
In case adding the "Factory or business site" obtaining the same JIS certification (hereinafter referred to as"factory"), perform on-site audit and conduct the items required for product test in accordance with thefollowing cases. (The factory in this interpretation also includes other factory of the same legal entity aslicensee)
1. Content of on-site audit<Case A> When the factory to be added has received JIS certification from the same accredited
certification body (hereinafter referred to as "CB")(1) When there is new possibility of risk of not conforming to JIS due to addition
Certification maintenance factory audit for the relevant factory and /or subcontract factory shall be
conducted by on-site audit.
[Notes] Example for on-site audit
Due to the addition, when new quality or production condition (including a process, equipment, testingand inspection, replacement of identification and symbols associated with the addition, a mechanism
for transferring information for approval of conformity and approval of shipment, etc.) or a combination
thereof exceeds the scope of certification and/or the scope of quality control system at factory or at
subcontractor's factory occur at the factory or subcontractor.
(2) When a new quality or production condition (including a process, equipment, testing and inspection,replacement of identification and symbols associated with the addition, a mechanism for transferring
information for approval of conformity and approval of shipment, etc.) or a combination thereof arises
within the scope of certification and/or the scope of quality control system at the factory to be added.
1) When a new quality/production condition or a combination thereof is the main process (hereinafterreferred to as the "main process" and the main process refers to the process determined to becritical to the quality by JISCBA and/or the respective accredited certification body.) etc.
On-site audit for the main process of the additional factory shall be conducted only when the CB
determines that it is necessary to confirm by on-site audit to the additional factory, as determinedby a) of JIS Q 1001 subclause 11.2 (modification or addition of the plant or businessestablishment), taking into account the quality of the production record since certification of thefactory to be added (including the evaluation of the effectiveness of the educational training) andthe stability of the operational critical control factors based on the conventional review.

2) When a new quality or production condition or its combination is other than the main process1On-site audit will not be made for other processes of the additional factory unless the CBdetermines that JIS Q 1001 subclause 11.2 (modification or addition of the plant or businessestablishment) results in the inherent need for on-site audit to the additional factory as a result ofconsidering the quality of the production record since certification of the factory to be added(including the assessment of the effectiveness of educational training) and the stability of theoperational critical control factors based on the conventional review.

<Case B> When the factory to be added has received JIS certification from a CB that is different fromthe certification of the factory or business site to which it is added(1) When there is a new risk of not conforming to JIS due to the addition
Same as (1) of <Case A> in 1.
(2) When a new quality or production condition (including a process, equipment, testing and inspection,
replacement of identification and symbols associated with the addition, a mechanism for transferring
information for approval of conformity and approval of shipment, etc.) or a combination thereof arises
within the scope of certification and/or the scope of quality control system at the factory to be added.
1) When a new quality or production condition or a combination thereof is a major process, etc.
Perform on-site audit of the main process concerned.
2) When a new quality or production condition or its combination is other than the main process
CB of the licensee of the factory to be added decide according to 2) of (2) of <Case A> in 1.
2. Contents of the product test
<Case A> When the factory to be added has received JIS certification from the same CB as thecertification of the factory to be added(1) When there is a new risk of not conforming to JIS due to the addition
Perform certification maintenance product tests on the relevant factory.
[Notes] Example of performing product test
In conjunction with the addition, when a new quality/production condition (including process,equipment, test and inspection) that exceeds the scope of certification and/or the quality control
system or the combination thereof occurs at the factory or/or subcontractor factory, and when the CBof licensee judges that it is required to be verified by product test under the specification of JIS Q 1001
subclause 11.2 (changes or additions to the factory or business site).
(2) When a new quality/production condition (including process, Equipment, test/inspection, etc.) or a
combination thereof arises within the scope of certification and/or within the scope of the quality control
system received at an additional plant.
1) When a new quality or production condition or a combination thereof is a major process, etc.
A product test is conducted only when the CB determines that verification by product test isrequired under the specification of JIS Q1001 subclause 11.2 (changes or additions to the factoryor business site), taking into account the quality of the production records since certification of thefactory to be added (including the evaluation of the effectiveness of educational training) and thestability of operational critical control factors based on the conventional review.
2) When a new quality or production condition or its combination is other than the main process2

Product test is not performed for any other process unless the CB determines that JIS Q 1001
subclause 11.2 (changes or additions to the factory or business site) will result in a specific needfor product testing as a result of considering the quality (including the effectiveness assessment ofeducational training) and the stability of operational critical control factors based on theconventional review based on the production record since certification of the factory to be added.
<Case B> When the factory to be added has received JIS certification from the different CB of thefactory to be added to.
(1) Due to the addition, there is a new risk of not conforming to JIS.
Same as (1) of <Case A> in 2.
(2) When new quality/production conditions (including processes, equipment, test/ inspections, etc.) orcombinations thereof occurs within the scope of certification received at the factory to be added
1) When a new quality or production condition or a combination thereof is a major process, etc.
Conduct a product test of the product to which the critical process is applied.
2) When a new quality or production condition or its combination is other than the main process
CB of the licensee corresponds according to 2) of (2) of <Case A> in 2.

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