Tag Archives: internal audits

Lean and ISO Working Together

Some people think that compliance with ISO 9001:2008 inhibits innovation and Lean transformational change. This is very far from the truth. I previously wrote about how compatible and complementary both methods are when implemented in the same timeframe. I will explain in more detail below.

ISO requires the organization to be engaged in Continual Improvement.  Lean provides one vehicle for a company to be focused on the customer, while constantly working at making the organization’s processes more effective.

ISO 9001 is designed in a Plan-Do-Check-Act (PDCA) format for Continual Improvement.  In implementing ISO, we plan for the development (Plan), we implement it (Do), we audit against the standard (Check) and we take corrective action when necessary and continue the cycle by identifying and pursuing opportunities for improvement (Act).

During the Planning stage, we can use the Lean principles to assure that the documentation is “value-added”, that they are truly needed, that procedures are written in a simple concise manner and that work instructions are made as visual as possible and easily understood by the user.  Procedures and work instructions should encourage their use and facilitate training and cross-training.

The key for the ISO implementation is to get a “snap-shot” of the Current State and to document it.  Value Stream Mapping, a Lean method, is useful in identifying process steps  and opportunities for improvement in the Current State and to document the possible improvements in a Future State Map.  A Continual Improvement Plan could then be developed to identify actions, responsibilities, and target dates for the improvements.

Significant improvements will be documented as “Preventive Actions” for follow-up in the ISO system.  Any improvement that reduces lead-time or increases product/service Quality is a valid candidate as a Preventive Action as it will prevent customer dissatisfaction.

In Lean, Rapid Improvement Events (Kaizen) address solutions to the opportunities identified in the Continual Improvement Plan. Once such solutions are identified, tested and implemented (again, P-D-C-A), the new process needs to be documented in the ISO system.

Lean uses the concept of “standard work”, a method that identifies the sequence of activities, the use of the resources needed, and the time planned to keep up with customer demand.  Standard work provides an excellent vehicle for identifying the “inputs” and “outputs” for each process as required by ISO standards.

Sustainability of Lean methods, such as the 5s workplace organization, requires following up and auditing to assure that the organization does not return to the “old ways”.  The ISO systems for conducting Internal Audits and taking Corrective and Preventive Actions provide methods for sustaining the Lean improvements made, provided these processes are standardized and documented.  Checklists can be written to include these improved processes so that they can be audited and monitored.

It all fits together.  There is no need to be concerned with a “chicken/egg” argument, as to which should be done first. Just plan what you want to do, then do it, check it and act on it! You will always want to make it better, and should.

Making ISO 9001 Part of Your Culture

Why make ISO 9001 part of your organization’s culture?

I have seen many companies registered to ISO 9001:2008 failing to take full advantage of the structure that this standard provides.  These organizations only see the marketing benefits of the certification while missing the opportunity to improve the quality of their products and services by testing their systems against their customer requirements.

ISO 9001 is a basic business process system that provides a solid structure for future improvements. In fact, this standard expects a continual improvement approach to quality and expects that organization fully understand and meet the customer requirements.

ISO provides an excellent roadmap for developing a culture that supports positive change. To maximize the benefits of ISO implementation, the ISO requirements need to become seamless with the workings of the organization.

Internal Audits need to be scheduled and conducted during the course of the year, not just before the external auditor is due to visit.  This helps to recognize and correct any nonconformity before any adverse consequences occur.

ISO requires that the organization establish systems for controlling documents, records, nonconforming products and changes in design.  These requirements are so basic that it is hard to imagine a company operating successfully without them.

Another ISO requirement, a robust Corrective and Preventive Action System is an invaluable tool for improvement. ISO expects that with every problem or potential problem, the organization will drill down to its root cause and develop a solution based on this investigation.  ISO’s emphasis on continual improvement is totally compatible and complementary to other systems and methods of business improvement and provides a platform for future evolution of the business in its journey towards excellence.

These very basic requirements need to be made part of your organization, not because they are ISO requirements, but because to succeed you need to make these part of your culture, that is, part of the way you do business.