[The following is a full chapter excerpted from the book Surviving ISO 9001:2015 by Christopher Paris. The book is available for purchase at www.survivingiso9001.com.]
If you recall, I mentioned that the entirety of the COTO Exercise was building up to the development of a “strategic direction” for the company. No, there really isn’t a clause 4.5 in the standard, and technically, ISO 9001:2015 makes no firm requirement for a strategic direction at all, but instead keeps talking about it as if it were part of a movie prequel you had already seen. Specifically, ISO 9001 name-drops this concept in five places:
0.3.1 The Process Approach: “The process [should] achieve the intended results in accordance with the quality policy and strategic direction….”
4.1 Understanding the Organization and its Context: “The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction….”
5.1.1 Leadership & Commitment: Leadership and commitment shall ensure “that the quality policy and quality objectives are … compatible with the context and strategic direction ….”
5.2.1 Developing the Quality Policy: The quality policy must be “appropriate to the purpose and context of the organization and supports its strategic direction.”
9.3.1 Management Review: “Top management shall review the organization’s quality management system … to ensure its … alignment with the strategic direction….”
Summarizing, ISO 9001 thus invokes this idea of a “strategic direction” by suggesting the strategic direction be considered five times:
- … when identifying processes
- … when identifying the issues of concern (during COTO Exercise)
- … when developing the quality policy
- … when developing the quality objectives
- … as a metric to measure the overall QMS against during management review
So, if you need to have a thing in order to conduct five required steps, it helps, therefore, to ensure the thing actually exists. Having said that, since it’s not a mandatory requirement, this means it can “exist” any way you’d like, even as a set of cohesive thoughts held by the top management and communicated verbally.
SpaceX had the most elegant strategic direction; when moving from an R&D house to a full production company, Elon Musk’s edict was summed up in two words: “forty cores annually.” This meant everything was adjusted to target a production goal of forty rocket cores per year: production capacity, engineering throughput, plant layout, staffing, budgeting… every single thing the company did was redesigned to “hit” the forty core mark. When asked, anyone in the company could recite a single goal – “forty cores” – and then go on to elaborate on how it affected them, in their particular department or function. Simple, elegant, and it worked.
But, as usual, SpaceX may be an outlier. Reducing your strategic direction to two words wouldn’t work in most companies. So, most organizations have far more complicated strategies: perhaps to expand in one market while getting out of another, or to grow the business by 50% in a five-year period. If that sounds a lot like a quality or process objective, that’s not by accident: the strategic direction should inform the development of the quality objectives, after all.
The strategic direction isn’t binding; it’s going to change over time. For SpaceX, once they’ve mastered “forty cores” it’s likely Elon will issue a new strategic direction statement, and it will probably be “get my ass to Mars.” So these things do change, and it’s not written in stone. I do recommend writing it down, though, and my best recommendation is to put it in the records of Management Review, which we will discuss in section 9.3.
I’ve found, however, that some executives don’t want their plans written down for general consumption by the company employees; one of my clients was pursuing ISO 9001 as a means of making the company more attractive to potential buyers, so his strategic direction was “to sell the company.” He didn’t want employees to get terrified and quit en masse, so he kept this very close to the vest. In such cases, it’s fine if the executive writes it down and keeps it private; there’s no requirement the direction be publicized or even communicated. In such cases, it’s the top management’s job to ensure the direction is being met, even if the employees don’t know what it is. It’s a good idea to have it written down, though, if only to show an auditor, in private.
So while it’s not a firm requirement, developing the strategic direction – and ensuring those five points above align with it – is a critical step in developing an ISO 9001:2015 quality system.