The ISO 9001 Process Approach Principle
We spent the past couple of articles defining the ISO support processes (ISO 9001 Support Processes and Document Control and Change Management). Let’s take a step back and and explore the fundamentals of processes and the ISO 9001 process approach.
One of the seven ISO principles is the “Process Approach” and it, along with “Customer Focus”, are probably the two most emphasized principles within the ISO 9001 standard and associated guidance information. Given that a significant amount of the eCoach ISO 9001 Learning System tasks involve development, control, and management of business processes, it might be of value to take some time to explore the ISO 9001 Process Approach principle and its application in your management system and organization.
The ISO 9001 process approach is prescribed throughout ISO 9001 and other similar management system standards and has been since the release of the ISO 9001:2000 version of the standard. Each new revision of the ISO 9001 standard (2000, 2008, 2015) has added ever increasing emphasis on this principle and I believe that this approach is the best method for defining, developing, and managing an organization’s processes, core value chains, and overall management system.
What Are Processes?
Processes are a part of our everyday lives, many of which we don’t even realize exist. We use a process to make breakfast in the morning, complete a shopping errand, and mow the lawn. We just don’t think of these activities in terms of inputs, actions, and outputs (results). But that is the way we should look at all the different activities that make our company go each and every day.
Most people see a company or organization through the different functions or departments that appear on the organization chart. We think of Sales, Marketing, Engineering, Customer Service, Production, Purchasing, Finance, etc. ISO encourages us to consider the interconnected or intertwined processes that form the overall system that is our company. Processes may include:
- Design and Development of products and services,
- Procurement of supplies and materials,
- Control and corrective action of nonconformities,
- Production of a product or delivery of a service,
- Resolution of a customer complaint or is,
- Review and approval of a sales order or contract.
Our organization consists of dozens if not hundreds of processes, both large and small, that allow the company to operate each day. Some of these processes are contained, controlled, and managed all within one function or department. However, many processes are “cross-functional” in nature as they touch and impact multiple functions within the organization. The outputs from one functional area process many times form the inputs for another functional process.
Consider the transition or transfer of a new product design into manufacturing and all the various activities and handoffs between the different departments. And consider how we often find that these processes experience the biggest dysfunction or disconnects at those points where there is an exchange or handoff between two or more functional areas or processes. Something to be aware of when developing and optimizing processes.
ISO 9001 Processes
ISO defines a process as “A set of interrelated or interacting activities that use inputs to deliver an intended result”. ISO’s process approach challenges companies to look at their organization as a collection of different processes which are interconnected to form a larger system (the organization).
Think of the inside of a pocket watch and all the different gears and cogs meshed together. Consider each component as an individual process, with each one precisely meshed and interconnect with other parts to form the watch (system). When properly designed, assembled and operated, the watch functions with great precision to generate the desire output (accurate display of time). Each component (or process) plays a critical role within the system and if one part is missing or fails to operate as designed, the entire system fails to produce the desired output or result.
The latest version of the ISO 9001 standard certainly increased the focus and requirements associated with processes and the process approach. Organizations must now:
- Define all the processes needed to operate your business and support the ISO 9001 management system.
- Define the inputs and outputs of each process,
- Define the sequence and interaction of your processes,
- Define what methods are required to execute and manage each process,
- Determine the criteria needed to ensure processes are under control,
- Determine all resources (people, equipment, facilities, utilities, environment, etc.) required for each process and ensure that these resources are available throughout the organization,
- Assign the responsibilities and authorities for each process (process owners),
- Define and address any significant risks and opportunities associated with your processes.
And in addition to these requirements you must also continuously evaluate, update, improve, and revise processes where needed and ensure appropriate documented information is maintained and retained where applicable.
The Anatomy of a Process
The figure below provides a simple diagram of the basic process components. You can use this basic approach as you consider and define the various processes within your organization.
Basic Process Diagram
There are many additional tools available to help with process definition, improvement, optimization, and documentation. The Turtle Diagram. below provides and alternative tool to be considered and used. You can also access this diagram in the EBS Free Members Library (MS Visio and PDF formats).
The EBS eCoach ISO 9001 Learning System provides additional guidance and examples for the development and use of these and other process development tools. In fact, we dedicated an entire learning system module (4 lessons) to provide guidance, tools, and information on how to define and develop your processes. For now, just grasp the general concept and start thinking about the various processes that exist within your organization and what tools might be best suited for defining and capturing them.
A significant amount of the work required to development and implement a formal management system such as ISO 9001 focuses on the development, optimization, and implementation of your organizational processes. For companies that already have well defined and effective processes, this work might come relatively easily and quickly. Companies that have not yet developed robust processes may need to allow and allocated appropriate resources and time to complete this work.
PDCA is a tool that can be used to help manage and improve processes and systems that has been fully integrated into and adopted by ISO 9001. This four-step process can be implemented and utilized as a process improvement method for just about any process and at any level of the organization. Sections 4-10 of the ISO 9001 standard actually form one large PDCA cycle as demonstrated below. Note that the PDCA model should be integrated into organizational processes at all levels of the organization.
PDCA stands for:
P – Plan: Set the objectives of the system and processes to deliver results (“What to do” and “how to do it”)
D – Do: Implement and control what was planned
C – Check: Monitor and measure processes and results against policies, objectives and requirements and report the results
A – Act: Take actions to improve the performance of processes
PDCA Within ISO 9001
PDCA operates as a cycle of continual improvement, with risk‐based thinking integrated at each stage of the cycle. This approach should be considered and used at the system level and within individual processes and organizational activities. The ISO standard aligns with the PDCA approach as follows:
- Define the context of the organization (Section 4.1 / 4.2)
- Define the organizations scope, policies, and objectives (Section 4.3 / 5.2 / 6.2)
- Define the organizations processes including: (Section 4.4):
- Sequences and interactions
- Determine and provide the necessary resources to achieve planned activities and objectives (Section 7):
- People / Competence
- Working environment
- Monitoring & measuring resources
- Organizational knowledge
- Documented information
- Implement and execute operational processes (Section 8):
- Verify process performance and effectiveness by comparing process outputs and measures against criteria and expected results (Section 9.1):
- Evaluate conformance of the management system against organizational requirements and the ISO 9001 standard through execution of Internal Audits (Section 9.2)
- Review the performance of the organization, management system, processes, products, and services to identify opportunities for change and improvement (Management Review) (Section 9.3)
- Take action to change and improve the organization, management system, processes, products, and services (Section 10)
- Address identified nonconformities through corrective action activities (Section 10.2)
Feeling a little overwhelmed? Take a deep breath and try to relax! Many of these activities and requirements will be incorporated into the various ISO 9001 processes as you develop and implement your management system.
Don’t feel compelled to use specific process development tools or methods. Use what works best for your organization, processes, people, customers, and company culture.
Also, don’t allow consultants or auditors to tell you that processes must be defined and documented using specific tools or methods. The ISO 9001 standard doesn’t specify particular tools or ways that processes are to be documented and you are allowed to define this information in a way that is appropriate for your organization.
We barely scratched the surface on this topic, however, there are volumes of additional information available online. Here are couple of key resources to continue your education: