Q: "I understand ISO 9001 section 4.2.1 describes the documentation I need. Letter 'd' of section 4.2.1 talks about, 'documents needed by the organization to ensure the effective planning, operation, and control of its processes.' What kinds of documents are they talking about? Is this the section that requires me to document all of our detailed working practices in formal work instructions?"

Dan Nelson of Cavendish Scott, Inc. (www.cavendishscott.com): "'Documents needed by the organization' are typically those currently in use to control operations. Included in this set of documents might be: forms or templates, work instructions, workmanship standards, travelers or routers, inspection documents/records, etc.
This clause of the standard does not require an organization to develop 'needed documents' beyond those already in use. If such documents were needed and not in use, it is unclear how the organization would ever succeed in meeting its obligations. If such documents are needed, then presumeably the organization is already using the documents.
In my opinion, the intent of this clause is to establish the documentation requirements of the standard, including documented policies, objectives, a manual, and procedures. These documents may not have been in use, as such, prior to an organization's pursuit of ISO 9000 certification. In 4.2.1 d), the standard is requiring recognition that documents already in use to control processing are part of the QMS documentation, and should be identified as such and controlled accordingly."

Snyder Rivera of Business Management Solutions: "4.2.1d refers to other documents as work instructions, flow charts, visual aids, shop travelers, setup instructions, forms, etc., as well as other records beyond what the standard requires that an organization feels without those other documents they will not be able to operate, plan and effectively manage their quality management system. This can include documents created in electronic media format, i.e., databases, spreadsheets, graphs, etc."

Patrick Hughes of Quality Consultant Management Services (www.pathug.com):"Normally the operation and control part will be inherently included in the Process Procedures. The trouble spot here is the word "planning". In the purest sense, in the approriate industries, this demands a deliberate procedure on pre-production-planning. Remember, if ANY surprises appear AFTER production begins, the planning was defective."

Andy Foss of Foss Quality Services, Inc. (www.fossqs.com):"First of all, documentation can be any format, such as text, diagrams, engineering drawings, flowcharts, photos, video, posted signs, etc. You do not need to document everything you do. That was somewhat the premise with the now-obsolete 1994 version of the standard. An important facet of the 2000 version is that you should document only what is needed and you get to determine that. Ask yourself, if this wasn't documented, could quality suffer? If no, there is no need to document. Some processes are either automated or driven by software, such as many order entry programs; in those cases documentation may not be useful. On the other hand, if a process requires knowledge or specified details that may be lost with a change of personnel, then documentation may well be required.

Chuck Richardson of Performance Quality Systems, Inc. (www.performancequalitysystems.com): "No, this section does not require you to document all your detailed working practices. It requires your organization to have the documents that are needed to effectively plan, operate, and control your quality management system. The determination of the documents needed is made by your organization based on the needs of the organization, customer requirements, and relevant statutory and regulatory requirements. Your organization should review its current documentation in light of current and potential problems and then decide whether or not to add documents or to increase the level of detail in existing documents. Such a review might also lead you to reduce the amount of documentation.

Ron Sedlock of The Quality Catalyst (www.thequalitycatalyst.com): "ISO 9001 does not have any section, 'that requires me to document all of our detailed working practices in formal work instructions.' This is a common misconception that has been around since 1987 when the ISO9000 series was first issued. A good rule of thumb is that detailed working practices are required where the absence of such details would directly affect product or service quality.
Also play attention to Note 1, 2 and 3 that follows section 4.2.1. There is some useful information meant to reduce your documentation. Maintaining an over documented quality management system is difficult and costly.