Transition to ISO 9001:2015

Larry Whittington presented “ISO 9001:2015 – Plan for the Changes” at the ASQ Audit Conference in Reno, Nevada. This article shares information from the transition guidance part of that presentation.

ISO 9001:2015 was issued on September 15, 2015. Organizations certified to ISO 9001:2008 have a three year transition period to make their move to the new standard before ISO 9001:2008 is withdrawn.

As you plan for the transition, remember to obtain funding for your transition activities. You will need to arrange for training on the new and changed requirements, as well as, possibly pay for extra audit days for your certification body to conduct the transition audit.

Context of the Organization

Understanding the context of your organization is a new requirement, although some organizations may already focus on their organizational environment. To transition to ISO 9001:2015, you’ll need to determine the internal and external issues that are relevant to your strategic direction, and that may affect your ability to achieve the intended results.

In addition, you need to determine the relevant requirements of relevant interested parties that may potentially affect your ability to consistently provide conforming products and services. You’ll have to consider these issues and interested parties when determining the risks faced by your organization.

Risk-based Thinking

A key purpose of a quality management system (QMS) is to act as a preventive tool. ISO 9001:2015 requires an organization to apply risk-based thinking to the planning and implementation of its QMS.

You need to first determine your business risks and opportunities, and then plan the actions needed to address them. Understand your options for dealing with these risks. Plan how to integrate these actions into your processes for ongoing prevention.

The effectiveness of the actions taken to address the risks must be analyzed and evaluated, and then considered at management reviews. Guidance on risk management can be found in ISO 31000.

Transition Guidance

One of the first transition activities will be to document the scope of your quality management system, as well as, the justification for any requirements that you determine are not applicable for that scope.

Be sure to advise top management of their expanded responsibilities. They may have to step up to demonstrate their visible leadership and accountability. They will need to align the quality policy and quality objectives with their business strategy. They may decide to hold more frequent management reviews to assess progress of the ISO 9001:2015 transition project.

The use of a management representative is not mentioned in ISO 9001:2015. You could decide to keep the management representative position, or disburse those duties among top management.

More Transition Guidance

After training on ISO 9001:2015, the organization should perform a gap analysis against the new requirements. The results can be used to develop your transition plan containing specific deliverables, assignments, and due dates.

Rely upon the transition guidance that will be provided by your registrar. Many certification bodies have already released transition white papers and made available transition checklists.

You will need to maintain conformity to ISO 9001:2008 until your transition audit to ISO 9001:2015 successfully completes. If you have another audit scheduled against ISO 9001:2008 before you are ready for the transition audit, you won’t be able to drop items no longer required by ISO 9001:2015, e.g., the quality manual and the required six procedures.

Additional Transition Guidance

If your current documents are working well, you may decide to keep them, even if they aren’t required by the new standard. There is value in having a documented process to capture knowledge, gain agreement, train staff, and provide operational control.

If your documents are numbered based on the old clause structure, will you stay with that numbering, although it will no longer be linked to the new clause numbers? Or, will you switch to the new numbers? Or, will you move to a generic numbering scheme that is independent of the standard clauses?

Scan for references to the old standard and its clauses in your existing documentation. Try to minimize these references and change any remaining references to the new standard and its clauses.

Further Transition Guidance

You don’t have to implement all the new and changed requirements of ISO 9001:2015 during the last few months leading up to the transition audit. Look for requirements that can be adopted early and be assessed by internal and external audits in the cycle before the transition audit.

Be aware that your internal audits may need additional planning, execution, and reporting time due to the introduction of the new and changed requirements.

Transition Starting Point

If your organization has invested time implementing ISO 9001:2008, and is almost ready for its certification audit, go ahead and complete the project in the next few months. Leave yourself plenty of time to then turnaround and begin your transition to ISO 9001:2015.

If you are just starting your implementation of a quality management system, then skip the use of ISO 9001:2008 and begin with ISO 9001:2015. Save yourself the later transition effort.

Transition Timing

Registrars will suggest you schedule the transition audit for your next recertification audit. The transition audit will be a full system audit, so planning it for a recertification audit will add fewer audit days (and less cost) than if you synchronize it with a shorter duration surveillance audit.

However, if you decide the recertification audit date is too soon for you to complete the transition, you can convert next surveillance audit to be the transition audit. And, if your recertification audit is too late in the three year period, you can use the prior surveillance visit as the transition audit. Or, you can arrange a special visit to schedule the transition audit in your preferred timeframe.

If you are currently assessed twice a year by your registrar, you may want to shift to an annual audit for the period leading up to the transition audit so you have more time to complete all the changes.

As you move through the transition, use it as an opportunity to improve quality and your business.

Presentation Handouts

If you are interested in receiving a copy of the following handouts, send an email to larry@whittingtonassociates.com.

1. ISO 9001:2008 to ISO 9001:2015 Clause Map (2 pages)
2. ISO 9001:2015 to ISO 9001:2008 Clause Map (3 pages)
3. ISO 9001:2015 Clause Quick Reference (2 pages)
4. Required Documented Information (4 pages)
5. Quality Management Principles (4 pages)
6. Risk Assessment Worksheets (4 pages)