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QMS Processes

Since the new versions of ISO 9001 and 14001 were released in 2015, and conversion from older versions is due by 9/15/2018, we are spending a few issues to look at some of the new concepts and their application.


The QMS and its Processes – for everyone, not just production!


The last time most of us focused on defining our processes was when we first documented our system, but an annual review of the entire system and how it works together provides an opportunity to identify gaps and resolve them. As you add products or services, or employees, or upgrade your technology, it is easy for documented processes to fall behind. So here are a few reminders:

  • Process-based thinking is core to all ISO standards now. A process is a set of related or interacting activities that deliver an intended result. Most processes have inputs from both internal and external sources, and in turn affect multiple other processes. Processes in a management system include not just operations, but administrative activities, and even those actions performed by external providers.

  • Determine the inputs and outputs of each process, and how they connect as a whole. What is needed for the process to be implemented as planned? What is expected by internal and external customers? These connections can be tangible (material, components, equipment) or intangible (data, information, knowledge).

  • Make the people who perform the activity the ‘process owners’, and have them ensure their activities are clearly defined within the documentation.

  • Determine and provide the resources needed for the process (people, infrastructure, environment, organizational knowledge, monitoring and measuring resources). Some resources may be externally provided.

  • Making sure processes are effective requires determining the criteria you use to measure their effectiveness, along with a specific goal. Each process should have at least one performance indicator that is then monitored, analyzed, evaluated, trended. This allows management and staff to make changes as needed to ensure the process meets its goals.

  • Ensure the use of Risk-Based Thinking (more detail on this soon) – taking into consideration how much the process affects the company’s ability to achieve intended results, the likelihood of problems occurring and the potential consequences of such problems. When risks are identified, they must then be mitigated or controlled within the system.

  • Continual improvement of the processes and system is still the goal.

  • Document what is needed to ensure process and system consistency – simple processes may require only simple explanations, complex processes require enough explanation to help people understand the task, the interrelationships, and how to make them effective. Maintain the integrity of documented info to direct activities, retain documented info to prove the process was followed as planned. How long you retain your documented info depends on technology, industry, and customer requirements.

Next month: Risk Based Thinking

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