Lean manufacturing is inconsistent with the requirements of ISO certification. The core of lean is waste elimination, while ISO adds waste by mandating a bureaucracy. The lean definition for success is lower inventories and reduced scrap. ISO's definition of success is an auditor's approval. The one thing in common to both is the process is never complete. Achieving one measure of lean spurs the organization to do even better with more savings. Likewise, every year the ISO auditor submits findings indicating that once again, the organization has fallen short and must keep trying to maintain compliance levels that were good enough last year. Despite this, many organizations are trying to achieve both lean manufacturing and ISO certification.

For example, if a process is making defective product, both philosophies react differently. In a lean operation, workers are given the authority to stop the line and identify problems. The root cause is immediately identified and fixed before the line is restarted. A typical ISO response, on the other hand, would be to get the procedure for placing product on hold, fill out stickers, and place samples on the Quality Assurance manager's desk so he can fill out a corrective action form. Meanwhile, the problem is contained, and the operation resumes with possibly lost production.

While ISO compliance is not typically optional, quality systems can be structured to meet the requirements and reduce waste. Getting corrective action (CA) lean is an important first step. A typical CA requires that paperwork be completed by QA. From the QA perspective, this ensures that the forms will be acceptable during an audit. For the operation, this is a disaster. The operation must wait until either QA can get there or the problem is pushed aside and work proceeds elsewhere. Paperwork should be completed by the person who finds the error. This enables the process to move forward instead of languishing. If the paperwork is completed by the workers, then it is a natural extension for them to complete the investigation and proceed as recommended by lean.

Corrective actions also usually require approval of the QA manager prior to implementation to ensure changes do not violate another element of the quality system. This is also not optimal as the corrective action must wait for someone in authority to review and approve it. Lean manufacturing encourages solving problems quickly so as to minimize or eliminate rework. Having an additional signature goes counter to this ideology by adding needless bureaucracy. The operators should identify what needs to be done and sign-off on the paperwork themselves. Educating the operators in the quality system will prevent them from causing trouble elsewhere.

Document control is another area that discourages lean manufacturing by designing systems that are convenient for QA but not the operation. Standard operating procedures (SOP) and work instructions are typically long documents comprised of mostly text and incomprehensible charts and tables. Deriving from QA, procedures are developed to be auditor-friendly enabling them to easily verify an organization's compliance to the standard. This approach is useless to operators who do not have the time to plow through a ream of paper to find process parameters, cleaning materials, or change over procedures. Manufacturing procedures should be a single page that can be physically posted right on or next to the equipment. They should make use of diagrams, symbols, and colors to communicate the process to the operator. Better for the organization for the auditor to trek out to the machine to verify compliance then have a procedure go unused because of the way its written.

SOP are also stored in cumbersome binders or on computers close to the manufacturing location. Again, binders are preferred by auditors who predictably conduct a desk audit of the operation rather than go onto the floor. Computers are also inconvenient because they are almost never next to each machine, but centrally located for more than one person to use. Worse case, the machine is in the supervisor's office so operators must wait until the personal computer is open before they can look up their procedures. In both cases, procedures are not really accessible to the people that use them. If procedures are to be followed, they need to be effortlessly available; otherwise, operators will work from memory preferring an imperfect recall than the hassle of finding the relevant procedures.

Lean and ISO certification will probably never come into alignment with one another, but with some foresight and a little delegation of authority, both can be achieved by designing systems that are both ISO compliant and lean.