ISO 9001 Standard Operating Procedures

An ISO 9001 SOP, or standard operating procedure, is a how-to procedure document format created by the International Organization for Standardization. Though it follows the ISO format, the document and the process belong to you and your company, whether it is about customer service, safety, manufacturing or some other facet of your business.

ISO 9001 is a set of standard requirements for general quality management systems. It is a part of the ISO 9000 family of international standards that affect most aspects of business operations and is the only one in the family for which a company can get certified. The ISO has defined the ISO 9001 specifications very broadly, allowing it to apply to companies of all types and sizes.

An SOP is a standard format that you can create in Microsoft Word, Google Docs, Mac Pages or a similar word processing app. It documents and communicates how you perform a particular procedure or process in your business. Creating SOPs in a standard format makes it easier to follow and digest the information they present. It also helps to keep a large set of documents manageable because they all follow the same format.

Standard operating procedures provide a standard guidebook for your business. Even the smallest organizations need written documentation to plan new processes, train new employees and refine processes so they improve with time. As a business grows, this documentation becomes crucial to consistency and quality.

SOPs are not set in stone; they are subject to revision. With time, your business adopts and refines its procedures and processes to work better and to adapt to changing circumstances. Also, SOPs may contain errors and glitches. It is good practice to review SOPs annually and update them as needed.

SOP development will happen to document a process already in place or when you are creating a new process. In the second case, you can treat the SOP as a “laboratory” in which you sketch out different ideas on paper before committing to a final version.

This approach works best with several stakeholders at the table, each offering ideas and looking out for potential problem areas. Brainstorming ideas at the outset can save you time and money down the road.

Though your business can reap significant benefits from SOPs, they still require effort to create and maintain. Time spent on SOPs might be time taken away from other tasks. The goal is the continuous improvement of your business processes but not to go overboard on documentation at the expense of more urgent matters.

SOPs are important to training new employees and refreshing people who have been doing the job for a while. It shows workers the exact steps needed to accomplish a task. At a bare minimum, new hires should receive training on SOPs. People working on safety-related and mission-critical processes might receive annual training on the SOPs to reduce mistakes.

A common feature of many SOPs is the use of a hierarchical numbering scheme to organize the various parts of the document and to show how they fit with other parts. Generally, major sections begin with an integer (whole number) followed by a dot (.) and a zero, and the numbers run in increasing order. Each lower-level part or subdivision gets that same main number followed by a dot and another number, beginning with one and incrementing for each line that follows as a sequence.

For example, part of an SOP might read like the following lines:

ISO 9001 SOPs and most SOPs in general follow a similar basic format. First, the document has a brief heading at the beginning containing the title, a document number, a revision number and a date.

The title is a short description of the contents. The document number assigns the document to a department such as purchasing or customer support; a given department can have many SOPs, each of which has its own number. The revision number is zero for the first version of an SOP and is increased by one for every revision made to the document after it is finalized. The SOP’s date is the date it was approved.

The first main section of the SOP describes the purpose of the document. The application, responsibilities and procedure sections follow. The application section describes the business function or circumstances to which the SOP applies. The responsibilities section outlines to whom the SOP applies in your company. Purpose, application and responsibilities are usually just a brief paragraph each.

The procedure section is longer, as it describes the actual steps of the SOP’s process. The section is divided into definitions and steps, each of which can be broken down into more detail by other subordinate lines. The section is as long as is needed to accurately describe the process.

A process can be a written step-by-step description, or it may be rendered as a flow chart. A flow chart consists of graphical symbols connected together that indicate different parts of a procedure. For example, a box symbol indicates a process step or action, and a diamond shows where you make a decision and how subsequent actions flow from the decision. A long oval denotes a terminator, marking the start or end of a process.

In addition to this information, the SOP may have a definitions section that explains jargon, technical terms and abbreviations. Definitions help auditors and new employees with possibly unfamiliar terminology.

An SOP may include an appendix or addendum that includes related documents. For example, an SOP that covers a truck safety inspection might include a checklist of the parts of the truck that are inspected.

Various vendors, including the ISO organization, have SOP templates available. You open them with your word processing app and fill in the blank spaces with your own content. Templates help jump start a new documentation effort in your organization or provide a convenient aid for experienced users.

By following the ISO 9001 standard, you are telling the business community that your company has achieved a level of management discipline that can be independently verified. Although certification is not mandatory, it can give your company a competitive advantage. Many businesses highlight their ISO status in their business-to-business marketing materials.

ISO 9001 is one part of the overall ISO 9000 group of standards. Other parts include ISO 9004, which is a guide to develop sustained quality management practices, and ISO 19011, which gives guidelines for auditing management systems. In addition, SOPs are only one part of ISO 9001, which covers quality management as a broad subject.