What Is a Lean ISO 9001 System?
The old adage frequently applied to ISO 9001 is “Say what you do and do what you say.” Some organizations take that to mean “write down everything you do,” but that is not what the standard requires. The practical requirement is that processes are well-defined, responsibilities are clear, and needed evidence is controlled.
A lean ISO 9001 system keeps the documentation that helps people work, train, audit, improve, and make decisions. It avoids the paperwork that exists only because someone once thought an auditor might ask for it. ISO lists ISO 9001:2015 as the current quality management systems requirements standard, while also noting that a replacement is expected within the coming months.
What Is a Lean ISO 9001 System?
A Lean ISO 9001 system is a quality management system that uses ISO 9001 controls without turning documentation into a separate bureaucracy. The goal is not to have fewer documents at any cost. The goal is to keep documents that add value, prove control, support training, and make continual improvement easier.
This can be accomplished through methods that require little documentation, such as training, visual controls, dashboards, process maps, and clear responsibility assignments. Using Lean ISO 9001 thinking helps the QMS become a boon, not a bust, to your organization.
Using Lean Thinking, you can reduce your organization’s reliance on procedure documentation where another control works better. A visual workplace can help trend and analyze performance. A lean corrective and preventive action Kaizen process can engage the workforce and communicate the latest improvements to employees.
There are two important aspects of a Lean ISO 9001 Quality Management System: a Lean Quality Manual and Lean Quality Management System procedures. Other documented information may also be needed, but each document should earn its place by supporting control, communication, evidence, or improvement.
Some may argue that adding documents is not Lean if they are not required. The goal, however, is not only to comply with the standard, but to add value to your organization and start on the path of continual improvement. Any document that helps the organization meet its goals and supports effective and efficient operations may be a document worth keeping.
What ISO 9001 Documented Information Is Needed?
What documented information may be needed to fulfill ISO 9001 documented information requirements? The table below lists documents to consider making part of your QMS. ISO also publishes guidance explaining how organizations can treat documented information flexibly while still controlling what is required.
|
Document |
Clause Number |
Rationale |
| Scope of the QMS | Clause 4.3 | Required (Typically, this is included on your registration certificate) |
| A flow chart or process map diagram to identify the sequence and interaction of required QMS processes | Clause 4.4.2 (to support 4.4.1) | As needed but strongly Implied (see clause 4.4.2, many registrars now require this document) |
| Quality Policy | Clause 5.2.2 | Required (Statement of satisfying requirements and continual improvement) |
| Organization Chart | Clause 5.3 | Optional, but an easy means to fulfill the clause. |
| Quality Objectives | Clause 6.2.1 | Required (Measurable targets) |
| Fitness for purpose of monitoring and measurement | Clause 7.1.5.1 | Required (gage R&R or Measurement Systems Analysis, MSA) |
| Measurement Traceability (calibration certificates, stickers, schedule, references to measurement standards) | Clause 7.1.5.2 | May be Required (Basis for calibration or verification, where measurement traceability is a requirement and standards do not exist.) |
| Validity of Previous Measurements (Analysis and/or data confirming action taken to validate previous measures) | Clause 7.1.5.2 | May be Required (Needed if measuring devices are found unfit) |
| Employee Competency (training plan, training records) | Clause 7.2 | Required (typically for QMS auditors, users of measuring devices) |
| Quality (Assurance or Control) Plan (New Customer Planning) | Clause 8.1 | Required, but not explicitly stated. Helps to organize activity from the customer’s viewpoint. |
| Requirements Review (Sales Orders) | Clause 8.2.3.2 | Required (Can the order be fulfilled as stated?) |
| Design & Development Planning (i.e. stages, project plan, resources, interfaces) | Clause 8.3.2 | Required (Evidence the design process is planned) |
| Design & Development Inputs (Requirements to be tested) | Clause 8.3.3 | Required |
| Design & Development Controls (reviews, verification, validation, test results) | Clause 8.3.4 | Required (Evidence the design process is complete; i.e test results) |
| Design & Development Outputs (Production work instructions, inspections, materials, tooling, setup instructions, TPM, handling, packaging, etc.) | Clause 8.3.5 | Required (show outputs meet required inputs; i.e. PPAP, FAI) |
| Design & Development Changes (Design revision log) | Clause 8.3.6 | Required |
| External Provider Evaluation and monitoring (Ongoing supplier data; i.e. receiving inspections, COC, COA) | Clause 8.4.1 | Required (Do suppliers meet standards?) |
| 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, action but there are various means to meet the requirement. |
| External Provider Information (Supplier Quality Manual) | Clause 8.4.3 | Required action, but there are various means to meet the requirement. |
| Production Control (see 8.3.5 implementation of outputs from design) | Clause 8.5.1 | Required (i.e. inspection records, completed setup checklists) |
| Identification and Traceability (i.e. labels, certificates, serialization) | Clause 8.5.2 | Required, if traceability is required (Serial or lot numbers) |
| Customer or External Property (i.e. email or notice of loss) | Clause 8.5.3 | Required, upon loss |
| Production Change Review (Change log, management of change process) | Clause 8.5.6 | Required (i.e. new production machines, process, methods) |
| Product or Service Release (Final inspection, issued COC/COA) | Clause 8.6 | Required (Evidence of quality and who released what to the customer) |
| Non-conforming Product (NC log) | Clause 8.7.2 | Required (Internal nonconformances) |
| Monitoring Measurement Analysis (i.e Run Charts, ppm logs, dashboards, SPC; Also audit results, supplier results, customer complaints) | Clause 9.1.1 | Required (System of performance monitoring) |
| Annual Internal Audit Schedule, program or Calendar | Clause 9.2.1 | Strongly Implied. Partial means to fulfill the audit planning requirement. |
| Audit Results (i.e audit plan for each audit, audit report of findings) | Clause 9.2.2 | Required |
| Management Review Meeting Schedule and agenda. | Clause 9.3 | Optional, but helps to ensure timely completion of the meeting(s) and agenda items. |
| Management Review Outputs (i.e. meeting minutes, PowerPoint, Excel data) | Clause 9.3.3 | Required (What were the results? i.e. decisions, actions assigned) |
| Corrective Action Results (i.e. nonconformity addresses, root cause, verification results) | Clause 10.2.2 | Required (What were the results?) |
Why Does Lean Mean Value, Not Small?
Some of the listed documents are required, so there is no choice. The goal is to keep the required document simple, ensuring that it provides value.
For the documents listed as strongly implied in the table above, there may not be a direct document requirement in ISO 9001. A document may still be the easiest way to meet the requirement, especially when the alternative is relying on verbal explanation during an audit or training event.
For the documents categorized as implied or optional, the organization needs to focus on the rationale for each item. ISO 9001 clause 5.3 requires top management to ensure responsibilities and authorities are assigned, communicated, and understood. An organizational chart is not the only way to do that, but it is a simple way to communicate responsibility clearly.
The same logic applies to records, dashboards, run charts, audit schedules, scoreboards, and corrective action results. A document is wasteful when it exists only for ceremony. It is valuable when it helps employees know what to do, helps managers see what is happening, or helps auditors confirm that the QMS is controlled.
How Do You Create a Lean Quality System?
Creating a lean quality system starts with the same question for every document: what value does this add? If the answer is compliance evidence, make the document easy to control and retrieve. If the answer is communication, make it visual and easy to understand. If the answer is training, make it usable at the point of work.
This approach can help organizations that need to comply with ISO 9001, AS9100D, IATF 16949:2016, or other quality standards. The time savings in using a Lean approach to QMS documentation can be dramatic, and so can the value of reducing paper. The greatest value, however, lies in having documents that are actually used and that aid the organization by providing value.
For organizations starting the journey to ISO registration, this approach helps put holes in the “documentation nightmare” myth. First examine whether the document is required. If it is required, ensure that it adds value when complete. If the document is not required but desired, make certain it reduces risk, improves control, or improves communication instead of adding bureaucracy to the QMS.
What Other QMS Documents May Help?
A simple matrix listing required documents, 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. That matrix also makes preservation decisions easier later, because every document has a stated purpose.
The end point is not a tiny QMS. The end point is a controlled, useful, lean ISO 9001 Quality Management System that employees understand and auditors can verify without hunting through needless paperwork.
Frequently Asked Questions
What Is a Lean ISO System?
A lean ISO system is a quality management system that keeps the documentation needed for control, training, evidence, and improvement while stripping away paperwork that does not add value.
Does ISO 9001 Require Every Process To Be Documented?
ISO 9001 requires controlled documented information where the standard calls for it and where the organization needs it for effective operation. It does not require a procedure for every activity.
What Documents Are Usually Needed For ISO 9001?
Common ISO 9001 documents include the QMS scope, quality policy, quality objectives, process sequence evidence, competency records, calibration evidence, review records, and corrective action results.
How Can Lean Thinking Improve a QMS?
Lean thinking improves a QMS by reducing redundant documents, clarifying process ownership, using visual controls, and keeping records focused on decisions, evidence, and improvement.
Why Should Optional QMS Documents Still Be Reviewed?
Optional QMS documents should be reviewed because some non-required records make responsibilities easier to understand, audits easier to complete, and process performance easier to improve.
