3 Easy Ways to Determine the Context of Your Organization
In this week's blog, we will dissect and better understand Clause 4.1.1. Of the ISO:9001 standard. This clause essentially changes the application and concept of clause 4. Context of the organization is a brand new requirement in this revision of ISO 9001, and your organization must now take into consideration both internal and external issues that can have an effect on strategic objectives and the planning of QMS. We now need to determine the context of our processes and procedures to comply with this clause.
So how do we do that? I'm so glad you asked…
1. Evaluate Your Organization. The first step is to look into your organization and evaluate processes, procedures, and context. Take time to evaluate all of the elements of your organization and their influences. Look at how they reflect on the management system. Take a look at your company's culture, flow of information and processes, company size, objectives, goals, complexity or simplicity of products, customers you serve, markets, the list can go on and on. You also will want to remember not to overlook the possible risks as well as possible opportunities regarding your company's business context.
2. Determine The Requirements. After you evaluate all aspects of your company, the next step is to determine which new requirements your company has already met in your existing documentation, and which are not yet met. If your company has already been using ISO 9001:2008, then you've already defined the scope of the management system and sequence of processes and interactions in your Quality Manual. Using these as an input to determine your context can save you time and prevents you from having to start from scratch! If you do have to start fresh and determine the scope of your management system, no big deal - the bulk of this task was done in Step 1 with your evaluation. Don't forget to determine and include your relevant interested parties. See last week's blog on for more information on relevant interested parties!
3. Document, Document, Document. After you've evaluated and determined your requirements, it's important to put pen to paper (or keyboard to monitor) and document your context. It is very helpful to document this context as a part of your scope within your Quality Manual. The standard does not specifically state that the context needs to be maintained as documented information, but it certainly helps with setting the strategic direction of the organization if the context is spelled out in black and white.
If you take a step back, your context already exists, this process just helps you understand and firm it up. Think of it this way - if someone asked you what your company does and who it serves - what would you tell them? Think of what your response would be. That alone will give you a great jump-start to understanding your context.
Ever been questioned about your data? Not questioned one-on-one sitting in your office, but more of an "on-the-spot, everyone I know is watching" kind of questioning? Yeah, not fun. As a healthcare data analyst, you aim to provide data that is accurate, representative, and helps the right people make the right decisions. So what happens when someone calls out your data in front of everyone and claims that it doesn't represent reality?
Yeah, I know how that feels. I've been there. But how do you really know if what you are providing does actually represent reality? (Psst - if you aren't sure if it represents what is really happening, how can we expect others to trust what you are providing?)
There are many ways (unfortunately) that data can become misaligned with what is actually happening and provide an inaccurate picture; formula errors, data extraction errors, data entry errors, and so on - but the one I want to talk about in this blog - random sampling - helps ensure data accuracy.
Random Sampling, what's that?
Random sampling is a technique used when it is not feasible or practical to obtain and analyze an entire population of data. In statistics, a population is the complete set of data for the question of interest. We can use random sampling to obtain a subset of data from the whole population in order to estimate what the entire population is telling us. That's a mouthful, I know.
Let's say you wanted to estimate the average length of stay of a hospital inpatient over the past 6 months. If you could easily obtain all of the patient length of stay data, you could just use software to add up all the individual "lengths of stay", divide by the total number of patients and "presto!" you'd have the average length of stay of the population (hospital inpatients in the last six months).
In the day of electronic medical records, the data for the whole statistical population is becoming more readily available electronically - which greatly simplifies our data collection. But what if you were interested in learning more about length of stay and the underlying causes - maybe something that is not available in a report and would necessitate a chart audit or some other manual data collection process.
How can you ensure that your sampling is representative of the whole?
When you sample, the key is to make sure your sampling is random - meaning you can't just take 15 patients from Unit A and 15 from Unit B and 15 from Unit C and so on. Nor should you just list all of your patients in order and take "every 10th" patient. You should have a method to randomly select - free from any selection bias.
Microsoft Excel has a really easy formula to truly take a random sample from a data set. Check out the video below and I'll show you how it works.
ISO 9001:2015 4.2 - Identifying and understanding the needs and expectations of relevant interested parties
It's very important to understand the needs and expectations of interested parties in your ISO 9001 management system. Interested parties will have an impact on your organization’s ability to provide products and services that consistently meet customer needs as well as legal and regulatory requirements. This article will help you in understanding the needs of interested parties and continuously meet their expectations.
An interested party is typically includes your customers, government or non-government organization, employees, owners or shareholders. You should know who your interested parties are for many reasons. To name a few, the management system scope needs to include the relevant interested parties' requirements, measurement traceability needs to be maintained- when this is an expectation of those interested parties, the quality policy is to be made available to relevant interested parties (when appropriate), and requirements for products and services may need to include requirements from relevant interested parties.
So, how do you get started?
In plain English, the requirements of the standard want you to be aware of the parties that have some interest in your organization, and to have knowledge of what their requirements are of your business. Follow these steps and you'll be on your way...
Finally, make sure this exercise is not just a one time analysis. The needs and expectations of interested parties are fluid, so you need a way to ensure this review takes place on a frequency that makes sense for your business.
The 2015 revision of ISO 9001 has removed the requirement of a Quality Manual, something that has been needed historically if your organization has wanted to achieve and maintain certification. This requirement appears no more! Woohoo! Shred those Quality Manuals and never look back!
Right? If the standard doesn't say we need it, then we don't need it. One less document to maintain. Finally, life as an ISO 9001 certified company is getting easier!
Let's hold on a second...
A common practice to create and maintain a Quality Manual for the ISO 9001:2008 standard (and earlier versions) was to create an exact copy of the verbiage in the standard, change all of the "shall" words with "will" or similar term that fits, change all references to "the organization" to the name of your company, slap a few logos on it, give it a control number and publish it.
And then...nothing. Let it sit for years until the new standard is published and then repeat this copy-paste process all over again. That practice, although common, doesn't help anyone.
It's Time to Re-Think the Manual
Now is the perfect time to rethink the Quality Manual. Take a step back and really consider what a manual should do for your company - provide the framework for your entire management system. Here are a few ideas to get you started.
Keeping your Business Manual Current
Even if your ISO Certified Company has a thorough and accurate Manual for the previous year, it is still very important to keep this document up to date. Here are some things to watch out for that may trigger the need for an update.
So, there are some things to think about. Even though the Quality Manual is not mandatory, it is still very much necessary. Use this opportunity to increase the role of the Manual within your business management system.
Do you have a have an interesting way that you have made your manual more valuable? Please share in the comments below.
Thinking of Outsourcing your Internal Audits?
Christopher M. Spranger, MBA, ASQ MBB
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