ISO 9001 Work Instruction Template

Mastering Quality & Consistency: Your ISO 9001 Work Instruction Template Guide

In the quest for excellence, organizations embrace the ISO 9001 Quality Management System (QMS) standard. The creation of clear and concise documentation is integral to an organization's QMS. Work instructions are one of those crucial elements of documentation that many companies struggle to create. In this blog, you will learn what an ISO 9001 Work Instruction Template is, what it should contain, and how it can help your organization.

Work instructions in an ISO 9001 context

Before going over the template, lets first clarify what a work instruction is, and how it fits in an ISO 9001 context

Work instructions

A work instruction is a detailed, step-by-step set of directions describing how to carry out a process or an activity. They are often used when a procedure is too general. Work instructions provide the necessary detail to complete a procedure correctly. In contrast to a procedure, they are not for the process manager but for the person performing the task. Work instructions provide guidance and are therefore very useful for achieving consistent results.

ISO 9001 and work instructions

Although a document "Work Instruction" is not specifically mentioned in the ISO 9001:2015 standard, it can be argued that work instructions fall under documented information, as defined by ISO 9001. The standard requires documented information to be created and maintained to demonstrate that processes are carried out as planned (see below).

• 4.4: Determine and provide the documented information necessary for the operation of the quality management system.
  
  

• 7.5.1: The organization shall determine the documented information necessary for the operation of its processes.
  
  

• 7.5.3: The organization shall control documented information to ensure that it is protected against loss of integrity or confidentiality, and that it is available and suitable for use.

Work instructions can be used to fulfill these requirements. A work instruction typically contains information about how to carry out a process or activity, and can therefore demonstrate that the activity has been performed correctly.

A work instruction contributes to:

• Consistent results.
  
  

• Process compliance.
  
  

• Training.

• Less errors.
  
  

• Audit trail.

The ISO 9001 Work Instruction Template

A good ISO 9001 Work Instruction Template is essential for the creation of standardized work instruction documents. A good template guides the user through the document creation and provides a solid structure for creating work instructions. A good template should contain the following sections:

1. Header information.

2. Purpose and scope.

3. Responsibilities.

4. Materials, equipment, tools.

5. Procedure.

6. Safety and environmental considerations.

7. Quality checks and acceptance criteria.

8. Records and documentation.

9. References.

10. Approval and review.

1. Header information

This section is straight forward and should contain the necessary document control information such as:

• Title of the document.
  
  

• Document identifier.
  
  

• Revision number / date.
  
  

• Effective date.
  
  

• Page X of Y.

2. Purpose and scope

The purpose should state the reason for the existence of the document, while the scope defines the boundaries of the document (i.e. what it is about and what it is not about).

3. Responsibilities

This section clearly states who is responsible for what. It can also be used to describe any other functions related to the subject of the document.

4. Materials, equipment, tools

A list of all necessary items to complete the task described in the procedure. This can include part numbers, specifications of tools and equipment, and safety equipment.

5. Procedure

The procedure section is the heart of the work instruction. It describes the precise steps in performing the task or process.

It is useful to write the procedure in numbered steps. Use clear and concise language. If applicable, use photographs, drawings, flowcharts, or videos to explain the procedure. This is often the section that can benefit the most from graphical support. Some points should simply be a heading, and some points should provide more detail. You can make use of If/Then statements. Critical parameters should be clearly stated.

6. Safety and environmental considerations

Any safety or environmental considerations should be clearly stated in this section.

7. Quality checks and acceptance criteria

This section describes how quality is ensured during the process described in the procedure. Mention specific points of inspection, measuring instruments, and what results are acceptable. Make sure to mention what action should be taken if unacceptable results are found.

8. Records and documentation

Mention any records that should be completed or maintained to ensure the completion of the process described in the procedure.

9. References

Make sure to mention any other documents that provide additional information, such as drawings, procedures, and specifications. Any documents that the work instruction refers to should be mentioned here.

10. Approval and review

This section serves to confirm the validity of the document. This is where you can add your approvers. The next review date should also be mentioned here.

Benefits of a standardized ISO 9001 Work Instruction Template

Having a standardized Work Instruction Template provides many benefits to your organization

The most important benefits are:

• Consistent work instructions across the organization.
  
  

• Compliance with ISO 9001 requirements.
  
  

• Easy training.
  
  

• Less errors and rework.
  
  

• Continuous improvement.

Tips for creating work instructions

Having a Work Instruction Template is great, but there are also some tips for actually creating the work instructions.

• Make sure that the instructions are clear, concise, and easy to follow.
  
  

• Avoid the use of complex language, make use of bullet points and numbered lists, and make sure each instruction starts with an action verb.
  
  

• Make sure to make use of any visual assistance where appropriate. A picture is worth a thousand words!
  
  

• Make sure to consult the people who will use the work instructions. After all, they are the ones who will use it on a daily basis. Involving them in the creation of the work instruction ensures that they have the most relevant information.
  
  

• Test the procedure instructions, and make sure it actually works and delivers the intended results.

Implementing and maintaining work instructions in your QMS

Creating work instructions is the easy part. For an effective Quality Management System, your organization needs to establish a proper document control procedure in accordance with ISO 9001 Clause 7.5.3. In your document control procedure, make sure to include the requirements stated in the ISO 9001:2015 standard:

• a) Documented information needed for the operation of the quality management system shall be provided and maintained.
  
  

• b) Documented information shall be controlled to ensure that information is available and suitable for use.
  
  

• c) Documented information shall be protected against loss of integrity or confidentiality.

Conclusion

An ISO 9001 Work Instruction Template makes it easy to create standardized work instructions. These documents can be instrumental in achieving consistent results, and ensuring compliance with ISO 9001 requirements. Using a Work Instruction Template can boost your QMS by improving processes, training, and audit trail. Invest in a good ISO 9001 Work Instruction Template to help your employees to do their job right, and delight your customers.