ISO 9001:2015 requires an organization to determine the boundaries and applicability of its quality management system (QMS). This determination lays the framework for establishing the organization’s scope, which is then required by ISO 9001 to be maintained as documented information.
 
When determine an organization’s scope, ISO 9001:2015 (4.3) requires that consideration must be given to:
 
1.       the internal and external factors referred to in 4.1;
2.       the requirements of relevant interested parties referred to in 4.2;
3.       the Products and Services of the organization.
 
What does this mean? The following are a few examples of scope statements, in this case detailing a fictitious company (XYZ) that provides machine shop services. While the XYZ company is fictional, these are actual examples of scope statements we’ve encountered, just slightly edited for illustrative purposes and to make this example:
 
Machine Shop Example #1 (Worst Example): “We are a machine shop.”
 
Commentary: required items #1 and #2 in ISO 9001 (4.3) are not addressed, and item #3 could be much, much better described with regards to the products and services the organization provides.
 
Machine Shop Example #2 (Slightly Less-Worse Example): “We are an industry-leading provider of machine shop services.”
 
Commentary: required items #1, #2 in ISO 9001 (4.3) are still not addressed, and item #3 could still be much better defined. Stating the you are an “industry leading provider” is not scope-related, and these types of adjectives and adverbs should be saved for marketing materials.  At this point, you’re trying to explain the boundaries and applicability of the management system, not position yourself to make a sale.
 
Machine Shop Example #3 (Slightly Better Example): “Company XYZ specializes in the precision machining of components for use in the automotive industry.”
 
Commentary: This statement is somewhat better than previous examples. This version of the scope statement covers the products and services of the organization and refers to, albeit in a very limited manner, the relevant interested parties and their requirements.
 
Machine Shop Example #4 (Even Better Example): “Located in Houston TX, Company XYZ is a high-volume machine shop that specializes in the precision machining of aftermarket aluminum brake, steering and suspension components, in accordance with OEM specifications and government regulations, for use in the automotive industry.”
 
Commentary: Now we’re starting to make some real progress. There is still more polishing to be done, but now this statement is coming closer to addressing all requirements. It likely won’t be possible to address every internal and external factor, every interested party and every product in your scope statement, but at least an attempt should be made to summarize these different considerations.
 
​
When creating your scope statement, bear in mind that this requirement of ISO 9001:2015 requires you to define the scope of your quality management system, not the scope of your ISO 9001 certification. ISO 9001 certificates also have their own scope statement, which is determined along with your certifying body, if one is used.
 
Note again, the scope of the quality management system is required by ISO 9001:2015 to be maintained as documented information. It is one of three requirements prescribed by the standard (scope, quality objectives, and quality policy), whereas most other requirements to maintain documented information are “as necessary”. Also, keep in mind that per ISO 9001, this information must also be made available to interested parties.
​

Pay close attention on this one….
​​​

1. Drain 1 can (14 oz.) of diced tomatoes and reserve liquid.
2. Remove diced tomatoes from can and spread onto a baking sheet; place in a 425-degree F oven for 20 minutes.
3. While the tomatoes roast, dice 1 large carrot, 2 celery stalks and 1 medium onion, then combine.
4. In a medium sauce pan on a cooktop, cook carrot, celery and onion mixture over medium heat for 10 minutes, until translucent.
5. Remove the roasted tomatoes from the oven; add tomatoes to the carrot, celery and onion mixture.
6. Also add to the mixture the reserved liquid from the tomatoes, 1 cup chicken stock and ½ cup heavy cream.
7. Simmer all ingredients together for 10 minutes, then remove from heat.
8. Mix with an immersion blender until a smooth texture is obtained.
9. Sprinkle with chopped basil.
10. Spoon into a bowl and enjoy

​ 
Congratulations! – You have just made tomato soup.
 
It seems like I'm asked at least every other day for a work instruction template. The example above, while typically referred to above as a “recipe”, is a basic form of a work instruction. As for a “work instruction template”, there’s no hard-and-fast rules to follow on what a work instruction should or shouldn’t look like; there’s no ISO 9001 requirement; there’s no standardized format or template that everyone is supposed to follow.
 
Communication in written form requires a sender, a receiver, a message and an action / result. In the above example, the sender is the author; the receiver is the cook; the message is the recipe; and the result is tomato soup.
 
What content is required? Work instructions should be developed with the user in mind, and should convey information as necessary to achieve desired outcomes (in the above case, “making soup”). How simple or how complicated this instruction needs to be is a matter between the author and their intended audience (the user), with adequate consideration given to the complexity of the task at hand (or lack of).
 
What a work instruction looks like, the information contained within, is up to the individual preparing. Some work instructions include sections on “materials”, “equipment”, “personnel”, “related procedures”, etc. Some work instructions don’t. Some companies even have specific rules (i.e., a company style guide) and how these documents should be formatted.
 
In any case, the Written Instruction Template can be, and definitely should be, whatever works best for you, your organization and the outcomes your trying to accomplish.
 
It’s cold today and now I’m going to have my soup.
​