Often, the words "process" and "procedure" are used synonymously to describe how something needs to be done. However, when you're developing a quality management system, they are quite distinct. In fact, quality processes, procedures and work instructions are three different concepts that form a hierarchy in quality management standards like the ISO 9001-2015.

A quality process explains in general terms what needs to be done and why. A quality procedure explains how the process needs to be done. A quality work instruction states how you should do the procedure.

Quality Processes, Procedures and Work Instructions

A process is a high-level description of the quality requirements, summarizing the objectives, specifications and required resources. A procedure adds more detail, specifying the responsibilities, the tools to be used, what is to be measured and how. A work instruction is a step-by-step guide of the process and procedure, written for the person who will be doing the work.

When writing your documentation, you should always begin with the processes. Each process should have at least one procedure, and there should not be a procedure without a process above it. If your procedures are sufficiently detailed, you may not have to write a detailed work instruction. However, if the procedure doesn't have enough information in it that someone relatively new to the position can't complete it without additional instruction, then you should write a work instruction.

Writing Quality Processes

In general terms, a process can describe any input that is turned into an output using defined resources. A process should define measurable objectives, inputs, outputs, activities and resources. This includes:

  • The information needed to start working and from where that information comes.

  • The basic jobs involved in the department and a description of the operations, activities and subprocesses required to produce the output.

  • The requirements of a finished output.

  • The recipient of the output.

  • The objectives for a job well done.

A basic process for processing a sales order could involve filling out an order form (input), ensuring the client's account is in good standing, emailing the order to the client for verification and then emailing the purchasing department with a copy of the verified order (output).

Writing Quality Procedures

A procedure is a standardized method for performing a process. It should generally contain information such as:

  • Why the procedure is needed.
  • What needs to be done and how it is to be done.
  • Who performs specific duties.
  • From where the inputs come.
  • Where the outputs go.
  • Location requirements if needed, such as where the work is done.
  • Requirements for an acceptable output.
  • Resources required, including tools, supplies and information.
  • Definitions of terminology used.

Consider this example of taking a sales order. Sales orders must be signed off by the client electronically before they can be processed. Sales orders are available in Excel format in the company's shared directory. All information in the sales order must be filled out, including the client's contact information.

Open the client's account information in the client database to verify the account is in good standing. If the account is flagged with a red icon, contact accounting for approval. Once the account has been verified, email a PDF copy of the order to the client. Once the client approves the order by replying to the email, forward that email to the purchasing department.

Writing Work Instructions

In some cases, the procedure is enough to explain what needs to be done and why. In other cases, even more detail may be required. For example, when detailing how sales orders should be taken, it may be necessary to include the names, extension numbers and email addresses of the accounting and purchasing department contacts.

It may also be necessary to explain how a PDF file is made from an Excel worksheet or even how to greet clients on the phone, with a script explaining to them that a copy of the order will need to be approved before it can be processed.