The best way to explain the requirement of clause 4.1.1a in ISO 9001:2015 is organizations are now required to identify the inputs and outputs of the processes of their quality management system. Since these terms can be a bit confusing for some:
Inputs: Resources that are needed or used in the execution of a process step (raw materials, labor, information, etc.).
Outputs: The results or outcomes that are created through the execution of a process or process step.
The key to this requirement is understanding the transformational process that is performed by your business to create the product or service your company sells. Word of caution here: DO NOT GET TOO DETAILED when you are identifying the inputs and outputs. At a micro level, businesses can have hundreds of processes or steps and to identify the inputs and outputs of all those steps would be a monumental task.
Start at a very high level
I find the best, and most effective way to comply with this clause and get a good understanding of inputs and outputs is to utilize a tool commonly used in Lean Six Sigma practice called a SIPOC diagram. The SIPOC diagram is defined as, "A tool used by a team to identify all relevant elements of a process improvement project before work begins. It helps define a complex project that may not be well scoped, and is typically employed at the Measure phase of the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology." (iSixSigma, 2017)
SIPOC diagrams are very easy to complete. Here are the steps you should follow to create your SIPOC Diagram and Identify the Inputs and Outputs of your organization.
1. Clear some wall space and assemble a cross function group (3 to 5 people are generally sufficient). Post some flip charts with headings (S-I-P-O-C) written on each, or headings written on post-it notes posted to a wall.
2. Fill in the process steps vertically in the Process column (the "P"). If your organization was certified to previous versions of ISO 9001, you will already have a high level process map documented in your Quality Manual. Use this map as your process steps in the SIPOC. If you are starting new, describe what your organization does in 5 to 7 steps (roughly). An example manufacturer could be something like this: Quoting - Order Processing - Engineering - Outsourcing - Production - Shipping - Invoicing.
3. Identify the outputs of each process step. Once the process steps are in the center column, outputs are easily identified by asking the question, "what does this process step create?". Post those in the "O" column next to the associated step.
4. Identify the inputs of each process step. Now ask the question - "what resources are needed to accomplish the process step?" and post those next to the appropriate step in the "I" column.
Note: Following those steps to this point will give you a great start toward the understanding of your business' inputs and outputs. You can stop here if you'd like - but if you want to utilize the tool to its fullest, you take the following two steps and use that information to begin the formation of your list of interested parties.
5. Identify the customers that will receive the outputs. For each output, ask who the person, department, or entity is that will be receiving the output and list those in the "C" column. These customers could be internal or external to your organization.
6. Identify the suppliers of the inputs. Ask who provides each listed input and document those in the "S" column. Much like customers - suppliers can be internal or external to your organization.
Once this exercise is complete - confirm the information and document it in the appropriate location within your management system. Understanding the inputs and outputs helps provide a foundation for what comes next - evaluating (measuring) the inputs and outputs to determine potential opportunities for improvement.
Thinking of Outsourcing your Internal Audits?
Christopher M. Spranger, MBA, ASQ MBB
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