ISO 9001:2015 Draft - Status

[John Broomfield]

LUV-d-4UM,

The processes you list appear to be outsourced from your local subsystem and you may need to think of two scope statements:

A. The scope of the management system
B. The scope of the certified part of the management system

Both the scope and objectives for your organization's process-based management system are determined by its process for soliciting the requirements of stakeholders (aka interested parties) of which manufacturing is one.

Certification bodies may allow narrower scopes according to their policy. Any change from the status quo may require a change to ISO 17021 first.

Or the CBs themselves may consider the adverse risks of services and products delivered by your subsystem which, possibly, have not been designed in accordance with a process that conforms to ISO 9001.

You could tap into the processes used by your corporate office to assess and manage risk so your part of the organizational management system can play its part in realizing opportunities (with quality services and products of course) while managing risk.

And you may find the corporate office already ensures their company-wide management system conforms to applicable national management system standards even though it may not be certified.

John

 

[kzachawk]

The US has great reservations about the language of Annex SL.
Here is the Ballot
http://www.erm31000.com/images/DISvote.pdf

Here is a link which contains the Comments and how they were clustered together
http://www.goingsustainable.com/news/progression-isodis-90012015/

For you folks in the United States, its best you obtain clear legal information related to the words "International and Law" which are found in Note 1 of clause 4.1 as there will be a great deal of consternation over the text of that note and its conflict with Article 2 section 2 sub paragraph 2 of the United States constitution. America has never ratified the Vienna Convention on the Law of Treaties (VCLT) and the VCLTSIO has never been approved. The United States government might not agree with a US organization attempting to forgo Constitutional authority by agreeing to implement international law in the United States, via a document written by a UN, NGO.

ISO can include the language in its MSS because its an international organization and many Nations have approved the VCLT, however the US Senate never ratified that document (and most likely never will). US corporations need pay attention to language such as this, and be sure to obtain legal opinion prior to proceeding, concerning the words International+Law as well as the other International+ list of sustainable initiatives which can be found in Note 1 of clause 4.1.

Corporate entities might agree with sustainable initiatives and international laws, however that does not mean they possess the authority to forgo the Constitution of the United States just because a UN, NGO (ISO) includes the language in their document. Its interesting that the same clause calls for adherence to Statutory and Regulatory requirements then lists items which clearly stand in opposition to those requirements in the United States.

 

[kzachawk]

If by your statements you indicate that design, sales and marketing take place at an offsite location, from where your manufacturing resides, and your manufacturing operations are independent (a separate entity corporate or LLC), then that arrangement changes the context of your organization and its scope under the proposed revision of ISO 9001 limiting your scope to only manufacturing activities. The other activities will show up as part of interested parties under 4.2 of the revised standard.

If however your company is one, (not a separate entity corporate or LLC) and you simply conduct sales marketing and design at an off site location; then those activities will become part of your system and scope under the 2015 revision of ISO 9001.

 

[LUV-d-4UM]

If by your statements you indicate that design, sales and marketing take place at an offsite location, from where your manufacturing resides, and your manufacturing operations are independent (a separate entity corporate or LLC), then that arrangement changes the context of your organization and its scope under the proposed revision of ISO 9001 limiting your scope to only manufacturing activities. The other activities will show up as part of interested parties under 4.2 of the revised standard.

If however your company is one, (not a separate entity corporate or LLC) and you simply conduct sales marketing and design at an off site location; then those activities will become part of your system and scope under the 2015 revision of ISO 9001.

If the second paragraph applies, who will become the interested parties, the customer and the CEO of my company?

 

[lawcch]

Interested parties can refer to shareholder, employees, suppliers, contractors, government/ authorities.
In ISO 9001:2015, we should look into boarder context when we identify biz risks, assess them and how to minimise those risks.

I read the DIS ISO 9001:2015 and FDIS ISO 9001 expected to publish in July 2015.

My comments to the new revision of the ISO 9001 are the terms and definitions used can be very confusing and some of the sentences rephrased can be misleading to the users/ adopter of this standard.

Lawrence

 

[qualityboi]

I am hearung hearing 17 procedures any media format...what are they?

Also .. and this is interpretation, there must be a risk management methodology in place for decision making in the Management Review...besides items mentioned in earlier posts.

Off topic I will no longer be auditing after tomorrow, 15 years! I am going to be presiding over fmea and control plans for the local mfg site, same company. More money, about 1/3 of the work, no more travelling on my weekends and late hours at hotel rooms preparing slides for closing meetings, or holding the auditees hands to close findings or lying to certification bodies and hiding design centers for top management. I look forward to the change going 50 to 60 hrs per week to 40/45.

.

 

[xfngrs]

Omnex's newsletter, Winter 2015 Navigator, also has a nice spread on current state of FDIS. And no I don't work for them. They aren't even our auditing body.

http://www.omnex.com/navigator/images/winter-2015-Navigator.pdf

 

[Kronos147]

Off topic I will no longer be auditing after tomorrow, 15 years!

Congrats!

I have seen a couple of assessors retire in the last few years.

In a few days I start full time with one of the registrars as a client manager. This is after the last 15 years in aerospace manufacturing.

It will be a big change for sure. I am interested in seeing other facilities, new processes, new people, and other interpretations of the standards.

 

[chasf]

Interested parties can refer to shareholder, employees, suppliers, contractors, government/ authorities.
In ISO 9001:2015, we should look into boarder context when we identify biz risks, assess them and how to minimise those risks.

I read the DIS ISO 9001:2015 and FDIS ISO 9001 expected to publish in July 2015.

My comments to the new revision of the ISO 9001 are the terms and definitions used can be very confusing and some of the sentences rephrased can be misleading to the users/ adopter of this standard.

Lawrence

Do you know off hand if the FDIS ISO 9001:2015 is the same in content as the final published copy? I have the FDIS ISO 9001 and am wondering if it is worth while to purchase the published one.

 

[lawcch]

AT last I had the published copy of ISO 9001:2015.

My overview comments are:
1) All terms and terminology used in revised ISO 9001 are found in ISO 9000:2015. Previously the DIS 9001:2015 they were included most of key terms and terminology in it.

2) Risk based thinking is mentioned but not clearly defined methodologies to conduct risk assessment if the organisations need to document the contingent actions to mitigate the identified risks.

3) there is no need to have SOP for critical processes but organisation has the freedom to decide what are the key or critical areas or processes to document.

4) The organisation needs to be more specific on how to achieve the defined quality objectives or KPI for QMS or critical processes.

5) defined the scope of QMS and quality policy statements are relevant and in line with the quality objectives.

Plus other many minor changes to the previous ISO 9001:2008.