ISO 9001:2015 - Is Strategic Planning audited?

Q

QAMTY

#1
Hi all

When reading the standard, the strategic direction term it is mentioned frequently, it seems we have to do different things that we did in the past.


Do you think that very different action an auditor will expect of it when auditing 2015?

In your opinion what actions do you plan to do but different to the one you have implemented in the past, considering the way the standard stress the term?

Additionally, it depends how important is the strategic direction, for some companies, will be considered just to comply with the standard, while others surely will implement really strategic planning.

Please share examples of strategic direction in your company.

Thanks
 
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B

BoardGuy

#2
Under ISO 9001:2015 strategic direction will be audited. The actual term is not defined, so my organization adopted the definition: “A course of action that leads to the achievement of the goals of an organization’s strategy” (Re. Business Dictionary.com, term: strategic-direction).

Now that it is defined as the goals of an organization’s strategy, Clauses 4.1, 4.2 and 4.3 become the inputs to the strategy that are reviewed during the management review meeting.

Within our "context of the organization" procedure we say the following forms the inputs to the strategic direction of the company:

· Scope of Products and Services
· Interested Parties
· Issues of Concern
· Organizational Risks
· Opportunities

My organizations strategic direction is: “The Company’s strategy is to grow and gain market share through superior performance and investment for the future

If you think about it, simple change from commercial work to medical device would impact the scope of products and services, add the FDA as an interested party, issues of concern now becomes meeting the medical device Standard and FDA regulations, organization risk increase as you now need to address medical device risk and opportunities increase as a new markets opens for the business.

[FONT=&quot]In this context does moving into medical device business [FONT=&quot]follows[/FONT] my organization’s strategic direction? I would say yes. Output from management review meeting: Strategic Direction has been met.
[/FONT]
 
#3
Every business owner knows the strategic direction of his company. He may not have shared it in the past, and some still may not.

Think of 4.1, Context of the Organization as the big picture of the company, you might say the view from 30,000 feet. It is often first developed during the conceptional planning of starting a business. That is the genesis of long term goals.

The organization may or may not want to share what those long term goals actually are to auditors or others outside of the company.

ISO 9001:2015 does not require them to be shared with auditors. 4.1 requires that external and internal issues that are relevant to their strategic direction be determined. Nothing about sharing them or recording them.

5.1.1b requires that the quality policy and objectives be compatible with the context and strategic direction. Nothing about keeping a record.

9.3.1 requires management review be performed to ensure the QMS has continuing suitability, adequacy, effectiveness, and alignement with the strategic direction.

9.3.3 requires keeping records as evidence of the results of management review. It would be a big stretch to assume these records would need to include disclosing what the strategic direction is.

In recap, virtually all viable companies have strategic goals or direction. They may or may not wish to share them, and they are not required to do so.
 
Q

QAMTY

#5
Thanks Boardguy

Please explain the next:When you defined the strategic direction " “The Company’s strategy is to grow....." it is stated in a special document?
and what is the relationship with policy, objectives, is it separated? is it additional?
on the other hand, in the output of management review meetings, how you will translate the strategic direction into facts?
A special document of a business analysis,some complex studies?, or just the same documents we usually used in 2008 version?
procedures, records, objectives, work instructions, and so on?
Please clarify.
Thanks
 
Q

QAMTY

#6
Thanks Big Jim

Ok, but what the auditor will ask?
if we answer, ok I have considered 4,1 and 4.2 and 4.3, but will be that enough?
to convince him that really we did a strategic analysis?
Thanks
 
#7
Here are some sample questions I stumbled on that could be asked while auditing top management.

What are some examples of current internal and external issues that you are attempting to address within your organization?

What methods have you established to determine, monitor and review external and internal issues relevant to your organization?

In light of these issues - how do you ensure that the strategic direction of the company is consistent with the quality direction of the company?
 
Q

QAMTY

#9
Thanks Ajit

I already read the article, it seems a useful guide, I noticed it involves
vision, mision, values,policy, goals, objectives.

It is an interesting issue, I always refuse to insert all these terms into a QMS.
because is hard to make people understand policy and harder , if I include vision, mision and values, I think it may cause confusion , and possibly
source of non conformances in audits if people cant explain clearly.

Don´t you think that is possible to make a good strategy by only using the policy and objectives?

Really do these terms add value into a QMS

Thanks
 

Paul Simpson

Trusted Information Resource
#10
<snip>The organization may or may not want to share what those long term goals actually are to auditors or others outside of the company.

ISO 9001:2015 does not require them to be shared with auditors. 4.1 requires that external and internal issues that are relevant to their strategic direction be determined. Nothing about sharing them or recording them. </snip>
Without wanting to start off our usual flamethrower debate. :truce:

How is the 1st requirement in ISO 9001:2015:
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 result(s) of its quality management system.
auditable if the organisation doesn't make its strategic direction available to an auditor?
 
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