The old adage frequently applied to ISO 9001 is “Say what you do and do what you say?” Some organizations seem to take this to mean “Write down everything you do,” but that is really not required by the standard. The actual requirement is that processes are well-defined and responsibilities clearly communicated. This can be accomplished through a lot of methods that require little documentation, such as training. Using a Lean ISO 9001 approach is one way to ensure it becomes a boon, not a bust, to your organization.
Using Lean Thinking, you can reduce your organization’s reliance on procedure documentation. Using a visual workplace you can perform trending and analysis that generates buy-in for change. How about a lean Corrective & Preventive Action Kaizen Process that engages your workforce and communicates the latest improvements to your employees?
There are two important aspects of a Lean ISO 9001 Quality Management System: a Lean Quality Manual and Lean Quality Management System (QMS) Procedures. But what about other documentation that may be needed?
Some may argue that it is not following Lean principles if you are adding documents that are not required. The goal, however, is not only to comply to the standard, but to add value to your organization and start on the path of continual improvement. Any document that aids the organization in meeting its goals and provides value in the goal of effective and efficient operations is a document that is needed.
Determining Needed Quality Documents
What are some of these potentially needed documents? Here is a table that lists documents you may want to consider making part of your QMS (referring to the ISO 9001:2015 Standard might make some of the descriptions more clear). Particular documents may not be required by the ISO 9001 Standard, however, creating a document may be the easiest way to comply with the intent of the standard.
Document | Clause Number | Rationale |
| A flow chart or process diagram to identify the sequence and interaction of required QMS processes | Clause 4.4.1.b | Strongly Implied (see clause 4.4.2, many Registrar’s now require this document). |
| Quality Policy | Clause 5.2 | Required |
| Management Commitment Statement | Clause 5.1 | Optional, but supports the “shall” statement |
| Organization Chart | Clause 5.3 | Optional, but is an easy means to fulfill the requirement |
| Quality Objectives | Clause 6.2 | Required |
| Employee Competency Evidence. | Clause 7.2 | Required |
| Grandfather Listing | Clause 7.2 | Optional. This is only used one time, when the QMS is initially developed. It can take the place of many records and helps the organization identify what tasks are important. |
| Quality (Assurance or Control) Plan | Clause 8.1 | Required, but not explicitly stated. Helps to organize activity from the customer’s viewpoint. |
| External Provider Evaluation and monitoring | Clause 8.4.1 | Required |
| Approved External Provider (Supplier) List | Clause 8.4.1 | Optional. Helps to ensure that only approved suppliers are used in the procurement process. |
| Outsourced Process Control Plan. | Clause 8.4.2 | Required, but there are various means to meet the requirement. |
| Work Instructions | Clause 8.5.1.a | Simple procedural documents that can be used in any area of the organization to facilitate a task or process. |
| Product or Service Release Criteria. | Clause 8.6 | Required, but not explicitly stated. |
| Non-conforming Product Log. | Clause 8.7 | Optional, but makes this process easy to audit and can be used to fulfill the record requirement. |
| Performance Charts | Clause 9 | Optional, but makes sense. Run Charts or graphics are an easy means to prove analysis. Also provides an easy means to communicate the data with employees or other parties. |
| Annual Internal Audit Schedule or Calendar | Clause 9.2.1 | Strongly Implied. Partial means to fulfill the audit planning requirement. |
| A specific Audit Plan for each audit or group of similar Audits. | Clause 9.2.2 | Strongly Implied. Along with an Audit Calendar, will fulfill the audit planning requirement. |
| Management Review Meeting Schedule. | Clause 9.3 | Optional, but helps to ensure timely completion of the meeting (s). |
Lean Means Value – Not Small
Some of the listed documents are required, so there is no choice. The goal it to keep the required document simple, thus ensuring that it provides value.
For the documents listed as “Strongly Implied” in the table above, there may not be an actual document requirement in ISO 9001, but it may be the easiest way to meet the requirements in the standard, as opposed to verbal explanations.
For the documents categorized as “Implied” or “Optional,” an organization needs to focus on the rationale for these items to see the value. For example, ISO 9001 clause 5.3 states, “Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. .” An Organizational Chart goes a long way to effectively communicate the responsibilities and authorities. Try substituting a few paragraphs of text for an Organizational Chart and one can see the value of a simple graphic. In some organizations, this is all that is needed to meet the 5.3 “shall” statement.
Overall, if an organization maintained all or most of these documents in a simple value-added format, then their Registrar Compliance Audits will go much smoother. As anyone who has been through the audit process knows that anything that will help the auditor facilitate a swift completion of the audit is a big plus.
Creating Your Lean Quality System
I hope this will assist those who with a Quality Management System, whether it is to comply with ISO 9001, AS 9100, IATF 16949, or other standards. The time savings in using a Lean approach to QMS documentation can be dramatic, as well as the value of saving paper. The greatest value, however, lies in having a document that is actually used and aids the organization by providing value, rather than a wasted document that never really used and only exists to be brought out at audit time.
For those who are just starting their journey to ISO registration to a Quality Standard, I hope that I have at least put a few holes in the “documentation nightmare” myth. As you go through your journey, first examine if the document is required. If it is, then ensure that when complete it is adding value to your organization. If the document is not required, but desired, absolutely ensure there is value and not added bureaucracy to your QMS.
Lean ISO 9001 Other QMS Documents
A simple matrix listing required documents and non-required documents, and the value non-required documents add may help you decide which documents are needed to meet the needs of your organization and QMS.
Best of luck to all of you changing your paradigm and instituting a Lean ISO 9001 Quality Management System.