ISO 9001:2015 Draft - Status

[Sidney Vianna]

ISO is making the Committee Draft available for purchase now.

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1765

 

[WCHorn]

Here is a link to a Quality Digest article that discusses the draft and "risk." I love the quote at the end of the article; "risk analysis is by definition a risky business."

 

[LUV-d-4UM]

"The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality management system

The organization shall update such determinations when needed.

When determining relevant external and internal issues, the organization shall consider those arising from:

a) changes and trends which can have an impact on the objectives of the organization;
b) relationships with, and perceptions and values of relevant interested parties;
c) governance issues, strategic priorities, internal policies and commitments; and
d) resource availability and priorities and technological change

Note 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local

Note 2 When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization"

I am quoting 4.1 of the new ISO9001:2015. What kind of objective evidence do we need to have to satisfy this clause of the standard? We have our policies and objectives and performance indicators but should we need to have more? Thank you.

 

[Colin]

Whilst not fully answering your question, I think this requirement will encourage auditors to make sure that the QMS aligns with the business needs and reflects the way in which they operate, rather than being an addendum which has been developed to meet the requirements of a standard.

 

[LUV-d-4UM]

Thank you. I think so too.

 

[Big Jim]

"The organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome(s) of its quality management system

The organization shall update such determinations when needed.

When determining relevant external and internal issues, the organization shall consider those arising from:

a) changes and trends which can have an impact on the objectives of the organization;
b) relationships with, and perceptions and values of relevant interested parties;
c) governance issues, strategic priorities, internal policies and commitments; and
d) resource availability and priorities and technological change

Note 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, cultural, social, economic and natural environment, whether international, national, regional or local

Note 2 When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization"

I am quoting 4.1 of the new ISO9001:2015. What kind of objective evidence do we need to have to satisfy this clause of the standard? We have our policies and objectives and performance indicators but should we need to have more? Thank you.

I think auditors may be able to look at management review for this. This is actually already in management review in the topic of "changes that could effect the quality management system". That's a wide upen topic. Many seem to limit it to internal changes, but the standard puts no such limitations on it.

 

[LUV-d-4UM]

Thank you. It looks like this new standard lifted a lot of ambiguous things in the ISO9001:2008.

 

[Peter Fraser]

<external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended outcome>
Surely "issues that are NOT relevant to its purpose and its strategic direction but which affect its ability to achieve the intended outcome" need to be managed as well. Is "relevant to its purpose and its strategic direction" relevant?

 

[Sidney Vianna]

Today is the deadline for the CD ISO 9001:2015 ballot and its subsidiary ballot, as well.

 

[LUV-d-4UM]

Good Luck in the voting Sidney. I am anticipating the release of the new ISO9001:2015 standard.