ISO 9001- Do we really need Context of the Organization?

 

Having recently completed an ISO 9001 training and learning about the context of the organization got me thinking about how the standard and companies get by without it up until recently. ISO 9001 released its most recent revision in 2015 and with it came a slew of changes. The standard was renumbered to 10 clauses in alignment with the High-Level Structure, verbiage was changed, the need for a quality manual was removed (believe it or not!) and the need for documented procedures left up to the company.

The first time I read the new revision I struggled to grasp what the committee that put this together were thinking. As I completed my ISO 9001 training with QMII it all started to make sense. ISO 9001 has included a lot of key changes to get more involvement from management, to make them more accountable for the effectiveness of the system and to integrate quality in all that the business does. Quality can no longer be an add-on left to the quality department to manage as the accountable entity.

Business schools teach students that those companies that do not learn to appreciate the market risks and innovate to stay ahead of the curve, often get overrun by innovators and eventually go out of business. Understanding the business environment is business 101 for any organization. Likely and hopefully, your organization’s leadership is already doing this. It may just be in the head of the CEO or done on a paper napkin, but it should exist. As I learnt in my ISO 9001 training, the standard does not require the context of the organization to be documented. Just that it should be monitored and reviewed. However, we all know that when auditors come to assess our system, they want to see a document for every requirement of the standard (even when one is not required). This complicates matters and is perhaps left for another time as it will be a lengthy discussion. Bottom line: document your system for the users and not for the auditors. Push back on high-handed auditors.

During my ISO 9001 training I learned that the context of the organization is the responsibility of the leadership and senor management team. To assess what are the potential internal and external issues that may impact the business, the product/service and the customers, both in a positive and negative way. Based on these inputs the Leadership team must identify strategic risks/opportunities that need to be addressed and then build in controls and/or resource the system to address these. It will also help leadership define if they need to expand the scope of the QMS e.g getting a plant in another country certified to meet customer expectations.

The ISO9001 training by QMII presented the standard in a structured format and clarified a lot of doubts I had. I now know that the monitor and review of the context takes place at each management review as defined in clause 9.3.2. So, planning for one’s business has always been around and ISO 9001 has included it in the standard to get leadership involved in their systems. As auditors we want to use these clauses to assess their engagement.