Explaining the Basics of ISO Standards: PLAN
For alignment with ISO standards and achieving quality improvements, starting with planning is crucial.
Have you ever realized, part way through a task, that you don’t have all the tools or materials you need? This is why ISO standards are based on the classic “Plan-Do-Check-Act” process approach. Let’s look at all four in more detail, beginning with Plan. You can read more about planning and the PDCA cycle is on our website, Plan-Do-Check-Act.
A Systematic Approach to Preparation
ISO 9001:2015 has four clauses involved in planning: 4, Context of the Organization; 5, Leadership; 6, Planning; and 7, Support. These are essential for determining business requirements and operations, and opening up opportunities for quality improvement.
What does ‘context’ mean? Clause 4 explains it as, generally, examining internal and external issues, in view of what the organization is planning to achieve. For instance, legal opportunities or restrictions, advances in technology, the market for your service or product, competition whether local, national or international. For instance, to open a taco truck, what about local regulations? Availability of ingredients? A unique recipe? The number of tacos you would expect to sell in a session? Location, including partnering with schools or large offices? Your profit margin? For a manufacturer, the list of factors is probably a lot longer, and each one can lead to success or failure, depending on how we approach them.
What are the perceived needs, or the expectations, of those interested in your company? Not only the buying public, but your employees and their families; unions; neighboring firms or housing developments; vendors who will supply utilities or services like waste hauling; and more. Click here for some more help.
Setting out the “scope” of your quality management system: combining the first two factors with what you plan to produce, tells you how you need to create and apply a system to produce services or products that meet customer requirements. How large and how complex will your operation be, and how will it be controlled to achieve your planned results? Are you machining, for instance, with metals only, or with plastics? Assembly work? Designing products or using customer specs only?
The scope statement enables you to create a system to manage that work, in a way that produces the desired results and keeps improving it: in ISO-speak, a “Quality Management System (QMS).” Figuring out the steps, the sequence and interactions, the methods, materials and responsibilities, and risks, just to name a few, then setting it down in an organized manner, sets expectations and lets you get started. To the extent necessary to support your processes, document it in some manner. For help in writing up your QMS, click here.
Leadership and commitment: Clause 5 sets out that the very top managers or owners in an organization have to take responsibility and accountability for the direction of the system, thus the company. There’s much detail about the responsibilities of those managers and their need to communicate their decisions and priorities to all members of the organization. A “Quality Policy” states those intentions and how the company goes about them, in general or specific terms, depending on what is being done. Going along with that are goals and objectives: measurable expectations from your QMS. Here is an article on the purpose of quality objectives.
Customer focus (duh!) isn’t always clear. Do you know the customer’s requirements – both what they’ve said, and what they haven’t stated but thought “any idiot should know”? In the taco truck illustration, how many customers might want dairy-free or vegan products? In manufacturing, do they want delivery ahead of the due date, or just-in-time on that date only? To maximize sales and customer delight, you have to know.
Setting out roles and responsibilities: this is usually pretty simple but can leave some with confusion if it’s not clear. Confusion leads to wasted effort or worse.
Risks and opportunities: Every business has to hedge against what might happen, both to harm the business and on the good side, to open up new ways to improve, expand or be the first to market with something new. While we can’t think of everything, without some thought in this way, you can get stuck big-time. So consider insurance, safety devices and PPE, additional training of staff on the intended results of the system, and so forth, to keep going in the right direction and ward off accidents, unintended results, and frustration for customers and staff. A four-step outline to analyze and decide on risks, is on our website. And see our extensive blog post on risk-based thinking for four different standards.
Resources (Clause 7) is the last step, and is a result of all the others: once you’ve set out the scope and direction of the company, the way you plan to operate, your risks and opportunities; then what you need -- in personnel, buildings/space, skills, equipment, utilities, raw materials, and all the other, will become much more obvious. Click here for some ideas on competence and training.
This is the PLAN step of Plan-Do-Check-Act. See the rest of the series for “Do, Check and Act.” And for more on this topic, including some tips on improvement, see our guide.
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