Leadership engagement critical to new ISO 9001:2015 standard

March 13, 2017|Schenck

To find success in implementing changes incorporated into ISO 9001:2015, you need to bring all leadership team members into the fold.

Many manufacturing companies have attained certification of their quality management system (QMS) to the ISO 9001 standard as a requirement of their customers, to improve their quality, to improve their processes, or all of these. If you are already certified to the ISO 9001:2008 standard, you know that in June of 2015, ISO released the 9001:2015 revision. For those certified to the 2008 standard, you have until 2018 to update your certification to the 2015 requirements to retain your certification.

As a consultant to the manufacturing industry and as a manufacturing executive who has led quality systems in my career, I am very aware that far too many companies struggle internally to keep leadership engaged in the process and instead put it all on the head of the quality department. The new 2015 update makes the engagement of leadership a requirement, and I have witnessed many quality leaders struggling to get the other leaders to listen and understand their increased responsibility required by the 2015 revision. Far too many are not engaging in learning the changes in the new standard and have not made any effort to start the transition.

ISO 9001:2015 makes process excellence a habit and part of the way you must do business. This is a culture change as well as a process change, and you cannot wait until the last minute to put compliant processes in place. To be effective, the transition from 2008 to 2015 needs to be a gradual implementation with use of Plan-Do-Check-Act (PCDA), which is the Deming method of continuous improvement.

Let’s first review some of the areas the new standard drives from the organizational and leadership perspective:

ISO 9001:2015 from an organizational and leadership perspective 

Context of the Organization The focus is not only on process quality, but also internal and external factors that can have an impact and how the organization approaches its product, services, and interested parties, not just the customer.
Identified Issues Not just physical product issues, but also internal/external and positive/negative issues that either affect or are affected by the decisions and outcomes of the organization.
Interested Parties All members of the company, suppliers, agencies and customers that are impacted by the decisions or activities of the company. Everyone is to be considered.
Leadership There is no longer a requirement for a single person to own the QMS as the “Management Representative.” There is a new emphasis on the team owning the QMS as it pertains to their area of responsibility in the business. Everyone is responsible.
Performance Evaluation Managing the QMS to deliver positive, predictable results through clear accountable ownership of the process and the results it produces.
Nonconformance and Corrective Action Clearer processes that involve the leadership of the impacted areas of the nonconformance. Investigations and corrective actions belong to those who are engaged in the processes impacted, not just the quality department.
Management Review A more detailed review of inputs and outputs that includes the leadership who has been involved in the process as outlined above. No longer a report to management from the “Management Representative.”

The ISO standards will be more aligned in structure and content with this change to 9001:2015. The evolution has incorporated more management engagement that can lead to performance improvement beyond process quality, and it has also strengthened the use of a continuous improvement philosophy.

As mentioned earlier, the PCDA process is now coupled with the ISO 9001:2015 sections (10), as outlined in the following graphic.

PDCA and the ISO 9001:2015 clauses

So, things have changed and the new standard has significant conditions for leadership engagement— and that is where the transition must start to be successful. The new 2015 standard is an opportunity to relook at where you are today with your QMS and where you want to go to be successful as a business in transitioning from the 2008 standard to 2015.

What do you need to do?

  • Take a complete and fresh look at the standard and your QMS
  • Utilize an expert to help you understand the impacts while you work in the whirlwind of your business
    • Benchmark other companies that have made the transition already
  • Highlight the key changes as opportunity for improvement across more than just your product or service quality
  • Make changes to your documentation to reflect new structure and responsibility
  • Implement new requirements on leadership, risk and context of the organization
  • Review effectiveness of current controls, review processes and measurements
  • Assume everything needs to change
  • Carry out an impact and gap assessment to understand the size and complexity of your transition

Do not wait for 2018 to start

Start going through these steps now as your conversion will be more than you expect in process and especially in culture changes with leadership responsibility.

Quality leaders who understand the transition from ISO 9001:2008 to 2015 are concerned and struggling to get other leaders to listen and understand their increased responsibility required by the 2015 revision.

The time is now to get serious about implementing ISO 9001:2015. Far too many leaders, all the way to the top, are not engaging in learning the changes in the new standard and have not made any effort to start the transition. Waiting puts your successful transition at risk and keeps you from gaining the improvements in results that the new standard can bring. The QMS is not something that is done to you, it is something done by you. ISO 9001:2015 should be the way you do business.

It does not matter if you implemented 2008 due to a customer requirement or just to improve your business. It must be driven from the top as will any business process or cultural change. Walk the talk and reap the benefits.

For assistance with your ISO 9001:2015 implementation efforts, contact a member of the Schenck Operations Consulting team at 800-236-2246.