ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments....

ogghall

Starting to get Involved
#1
The 2008 revision required ensuring control outsourced processes. My question is does the 2015 revision requirement now require the same level of control to be applied to these outsourced processes that had and still are for the traditional purchased product? For example would calibration services, equipment maintenance, transportation, and employment recruiting services now require, "evaluation, selection, monitoring of performance" criteria be determined and applied for them? Where in the 2008 standard they were required to be controlled to the "type and extent" we defined?
 
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BoardGuy

Quite Involved in Discussions
#3
Re: ISO 9001:2016 - 8.4 Control of externally provided ......

Most of what is contained in ISO 9001:2015; Section 8.4 comes from a number of locations within ISO 9001:2008. Clause 4.1, Note 3, Control of Outsourced Process (under scope of your registration), 7.4.1, Purchasing, 7.4.2, Purchasing Information, and 7.4.3, Verification of Purchased Product

Outsourced Processes are process you have not excluded from you scope of registration such as design and development, Section 8.3 of 2015. In the example of design and develop, when you outsource this work to a 3rd party you are not absolved of the responsibility of conformity to ISO 9001:2015 Section 8.3, customer, statutory and regulatory requirements.

The good news is when some of these processes are outsourced, such as calibration; you communicate the requirements from Section 7.1.5 to your calibration service via a purchase order and then verify their compliance upon receipt. Other elements of 7.1.5 you perform in-house such as reviewing the calibration certificates for out of tolerance conditions and adjusting calibration intervals.

Measurement of supplier performance is not new. Organizations and their certification bodies may have overlooked a measurement of supplier performance in the past but now it more directly stated in 2015.
 

ogghall

Starting to get Involved
#4
Re: ISO 9001:2016 - 8.4 Control of externally provided ......

In the 2008 revision 7.4 dealt specifically with Purchased product. As you mentioned most of what is in 2015's 8.4 comes from 7.4 except that 8.4 also includes "externally provided processes..." It does now appear as "howste" answered Yes to that the standard is requiring the "evaluation, selection, monitoring of performance" of those other processes outsourced. 2008 4.1 did not require the same amount of control so to speak as 8.4 now does. For the most part I am not referring to the complete outsourcing of a process but certain portions of a process. For example some calibrations, some external maintenance, etc.

I think referencing 7.1.5 regarding calibration besides identifying requirements in a PO now requires more then reviews of the certificate for the calibration results but includes how calibration facilities will be evaluated. For example their delivery, the quality of their calibrations, the quality of their paperwork, etc. And the records of those reviews.

Thanks for the response
 

BoardGuy

Quite Involved in Discussions
#5
Re: ISO 9001:2016 - 8.4 Control of externally provided ......

Yes ISO 9001:2008 4.1, Note 3 does speak to requirements of outsourced process because if you did outsource them the note becomes applicable and must be applied in some form. 4.1 now show up as 8.4.2 D) without the reference to “outsource”.

Don’t over think requirements of 8.4. Yes, you are more directly required to apply appropriate controls to the organizations direct and indirect suppliers to assure requirements for product and service can be net but you must do so within resource constraints of your organization.

What are some of the requirements for outsourcing calibration? That would be Section 7.1.5 along with 8.4. Design and development, Clause 8.3 plus 8.4. Special process supplier like plating would be Clause 8.5.1 plus 8.4.

Hope this helps.
 

Kronos147

Trusted Information Resource
#6
Re: ISO 9001:2016 - 8.4 Control of externally provided ......

I think a little difference between ISO 9001:2008 and 2015 is that the auditor will also be poking around for Risk Based Thinking and how it was integrated into your system.
 

LUV-d-4UM

Quite Involved in Discussions
#7
re: ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments....

If your company is a TIER 1 supplier to OEM, is it mandatory to have your supplier certified for ISO/TS 16949 Requirements? Thanks.:)
 

dubrizo

Involved In Discussions
#8
re: ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments....

If your company is a TIER 1 supplier to OEM, is it mandatory to have your supplier certified for ISO/TS 16949 Requirements? Thanks.:)
Depends on the particular OEM's requirements. IATF 16949:2016 goes so far as to state that suppliers of automotive equipment shall develop a QMS which is to become certified to ISO 9001 with the end goal of certification to IATF 16949 (unless otherwise authorized by the customer).

Hope that helps a bit
 
#9
re: ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments....

8.4.1 I am really confused on this issue. Controls of External Providers/Drops Shipments

We are authorized Distributors for several lines. We Drop Ship bearings, motors, etc, directly from the Manufacture to the Customer. For Controls we have always used our AVL, Supplier Performance and have then Vendor send us their Manufacturers Certs and their pack slip.

My auditor states this is not sufficient for control. He suggested source inspection at the Vendor whenever we have a drop ship. What??

Any suggestions??
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
re: ISO 9001:2015 - 8.4 Control of externally provided-Distributor & drop shipments....

My auditor states this is not sufficient for control.
You are probably dealing with an inexperienced auditor. You have to ask the auditor what EXACT requirement would force a distributor to inspect a product intended for drop shipment, manufactured elsewhere. Especially when the product is delivered with a manufacturer certificate of conformity.

When an auditor basically comes to a conclusion that a business model tested and tried for decades is inadequate, someone must question this auditor's business acumen.
 
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