All ISO management system standards require your business to maintain documented information. This documentation information includes policies, procedures and records. Unlike ISO 9001:2008, the newest version ISO 9001:2015 has reduced the number of mandatory documented information required.

What is a procedure?

Procedures are documented information that shows detailed steps required to perform an activity within a process. A typical procedure provides step-by-step instruction on how to complete an action. Usually, procedures are written in word format that documents scope, objective, procedural steps, reference to applicable requirement and other documents and responsibilities.

It should also be noted that business process can be documented on process maps, checklists and work instructions.

The following key steps will help you document a procedure:

Step #1: Define scope and objective

The crucial first step in developing a procedure is to define the scope and objective of the procedure. The scope should detail the process limits and scope of the business process for the procedure. The document should also determine the purpose of the procedure and what it aims to achieve. In some cases, procedures are written as a risk mitigation measure with regards to training, communication, compliance with the legal requirement, business continuity, product and service quality.

Step #2: Determine process information 

Before writing the procedure, you need to understand the activities within the process and collect adequate information about the process. This information should include activities, stakeholders, reference documentation, legal & other requirements, objectives and targets. One way to understand a process and determine the required information is by using the below turtle diagram.

1. Process Activities
2. Inputs
3. Outputs
4. What: Equipment & material
5. Who: People & Competence
6. How: Methods & Documentation
7. Result: Objectives and Targets.

Step #3: Process alignment

A procedure is written for a specific purpose, scope and objective. It is essential to align the process to business context (internal & external issues), needs and expectation of stakeholders and other business processes. Alignment is the key to unlock operational efficiency, and it makes the system leaner. Within the business, the outputs of one process are the inputs of another process and vice versa. Hence, changes to one process can significantly impact the other business process.

Step #4: Document structure

After collecting all the information regarding the process, the document structure should be developed. A typical procedure template with include the below headings

• Scope & Objective
• Reference to legal requirements, other requirements and ISO standard requirements
• Definitions
• Responsibilities
• Procedure (methods and activities)
• Reference to related documentation (Checklists, records, templates, registers, forms etc.)
• Document control (approval, change control, versions etc.)

It essential to maintain the structure of procedure and include document control as part of the documentation. It is a requirement of the ISO management system standard that all documentation information within the management system should be controlled.

Step #5: Write, Review and Approve

It is recommended the subject expert on a particular process who has in-depth knowledge and understanding of the process to write the procedure. Sufficient information about the procedure should be written, but keep in mind to make sure the procedure is not voluminous and easy to read and understand by other stakeholders. After drafting the procedure, you should have it peer-reviewed by colleague or manager. Top management/Senior Management should be responsible for approving the procedure before publishing it for use.

Step #6: Communication & Train

It is vital that all approved procedures be communicated to relevant stakeholders. Changes to the procedure should be highlighted and made understood. Where required, training should be provided to staff on how to use the procedure and implement the steps written in the procedure.