Why the 'Context of the Organization'?
One of the first things that people will notice about the 2015 version of ISO 9001 – if they are familiar with the 2008 version – is the adoption of the “Annex SL” layout of the requirements. This layout is going to be a common theme across many management system requirements.
The first requirement (section 4) isn’t about the management system per se, as in ISO 9001:2008, but something else entirely, named the “Context of the Organization.”
What Is The Context Of The Organization?
According to clause 4.1 of ISO 9001:2015, an organization must now look at both the internal and external issues surrounding its purpose, objectives and ability to achieve the desired results of its quality management system (QMS). These issues can be any positive or negative factor that influences your QMS, company culture, productivity, customers and other vital aspects of your business.
The clause's definition of context of the organization is quite general, so many organizations feel lost in pinpointing various external and internal issues. However, you should focus mainly on issues that will affect your products' or services' quality or your customers' satisfaction. These factors might include:
- Internal: Internal issues include your business approach and practices, performance, customer relationships, company culture, values and beliefs.
- External: External concerns involve any matter that arises from technological, legal, economic, political, cultural, societal or environmental roots. For example, changing government regulations, evolving technology and economic growth or decline are all factors that can affect your business on a local, national or international level.
The Concept Of Context Of The Organization
The 2015 revisions to ISO 9001 are the result of customer feedback from users all over the world. Clearly from experience, something was needed to frame some requirements for them to come together more cohesively when defining an organization’s Quality Management System.
In the previous revisions, it wasn’t very clear how some requirements were supposed to work in harmony with the result that some aspects of the resulting QMS. A pictogram was used to describe major groups of requirements, but the details of how to frame the various “sub-elements” weren't clear.
For example, ISO 9001:2008 required the following to be established:
- quality policy
- quality objectives
- a quality manual
- the scope of the quality system, including
- any exclusions and their justification.
With the exception of the quality policy being established as a framework for setting quality objectives, it’s not explicit, from reading the standard, how the components are to be framed into the resulting Quality Management System. Thus, section 4 was introduced to guide organizations in making evidence-based decisions for their QMS. As you continually monitor and review the information surrounding these internal and external factors, you can decide how to best improve your QMS to meet various needs.
Context Of The Organization Example — Under Promise, Over Deliver
The famous sales person’s maxim should have a familiar ring when it comes to setting up the Quality Management System. However, it’s often the case that in the enthusiasm for getting certified, the creation of documents listed above, key points are overlooked. A commonly missed opportunity is the creation of a meaningful and appropriate quality policy statement. Many are cut and pasted from another example and look like this:
“It is our Organization’s Quality Policy to Meet and Exceed Our Customers’ Expectations…”
While this would seem fine and dandy on the surface, and won’t necessarily cause a finding during an audit, it might not be appropriate for the “context of the organization.” Let’s consider the difference between a well-known fast food business, which has sold “billions” and compare that to a single site, gourmet restaurant.
Would the above quality policy statement be suitable for both businesses?
If we consider the context of each organization, we’ll see that it’s unlikely to be so:
When customers (an interested party) go to fast food businesses, they frequently choose it because
1. They are hungry
2. They know what they want
3. They can be served quickly
The menu is often shown to the customers as pictures with portion size options, as individual selections or “meal deals.” There aren’t many options for the way the food is cooked, side dishes or beverages. The servers are only required to be familiar with basic food preparation processes. Suppliers (another kind of interested party) are expected to supply the same thing, without deviation and they may be located in a variety of areas across the country.
In review of the Quality Policy, can we say the fast food business exceeds customers’ expectations?
Turning to the gourmet restaurant, it’s unlikely that the customer is there for the same reasons as listed above. The time frame allowed for the meal can be lengthy, the menu may present options that weren’t known to the customer, and the options available may require careful consideration.
As a result, the menu is unlikely to be shown in a similar way – using pictures, “meal deals” etc. The serving staff are often well trained in food preparation methods, pairings of beverages (wines for example), and may even suggest side dishes to compliment the customer’s choice. They are, however, highly unlikely to ask a customer who has ordered a chateaubriand, “Do you want fries with that?”
Similarly, they may have a small number of locally based suppliers who they rely upon to provide a variety of products which may change with the seasons, etc.
In the context of such an organization, it is most likely they will exceed customers’ expectations.
Both are places to eat which serve their food, in accordance with food safety regulations, produce a “quality product” and who satisfy their respective customers. The fast food business meets its customers’ needs, and the gourmet restaurant may, indeed, exceed expectations.
Implementing A QMS Based On Context Of The Organization
How does a company use its context of the organization information to satisfy ISO 9001 demands? A pyramid has been used in the past to depict the various levels of documentation of the Quality Management System, to meet ISO 9001 requirements. Its structure is as follows:
- Manual: The top tier of the pyramid contains the policy manual. This document outlines what will be done within an organization and why it will be done that way — often influenced by internal and external issues.
- Procedures: Quality procedures outline the "who," "what" and "where" of a policy — who should perform specific tasks, when they should do so and where to document their results.
- Work instructions: Written instructions should provide step-by-step definitions that explain in detail how to accomplish the tasks outlined in the procedures.
- Records and documents: The entire process should be compiled into records proving that the policy manual, procedures and instructions have been followed correctly. These documents allow traceability of action from beginning to completion.
By implementing this pyramid-like system, you can ensure your compliance with ISO 9001. At the base of this system is the context of the organization. Since various internal and external forces can affect your company's ability to perform proper procedures and instructions, understanding these factors will help you create a QMS that you can reasonably sustain.
Contact NQA For ISO 9001 Support And Certification
Determining the specific factors that hinder you from achieving your QMS's goals can be challenging. Instead of doing it on your own, let NQA help. We offer quality management services suited to businesses in any industry. After determining the issues affecting your business' quality, we can help you improve your processes and performance to overcome these challenges and make your business the best it can be according to ISO 9001 standards.
Increase your business' efficiency, compliance and customer care with an effective quality management plan. Contact us online or at (800) 649-5289 to learn more.