What is a Work Instruction in ISO 9001?

Although ISO 9001:2015 states that Work Instructions (WIs) are no longer required (they now refer to them as ‘documented information that defines the activities to be performed and the results achieved’!), it seems nowadays (well it certainly does to me!) that whenever you purchase something that you will need to assemble yourself (e.g. a fruit cage) or use (e.g. a simple car hoover) a WI is included in the packing box. So whatever you call this – a WI or ‘written guidance’ – it is still part of the overall Quality Assurance chain

What is the difference between Procedure and Work Instruction ?

In a nutshell:
  • Procedures: tell you who does what and when;
  • Work Instructions: tell you how to do something at a more granular level. Work Instructions provide the ‘nitty gritty’ detail required to carry out a specific job in an exact manner and to a predetermined standard. They detail how an organisation manufactures a product or supplies a process or service – as well as the controls that it has in place to ensure the quality of that product and service, etc. is consistent.
WIs describe, in detail, procedures such as ‘what is to be done’, ‘who should do it’, ‘when it should be done’, ‘what supplies, services and equipment are to be used’ and ‘what criteria have to be satisfied’. These WIs should be regularly reviewed for their continuing acceptability, validity and effectiveness.
What is the difference between Procedure and Work Instruction ?

How to write Work Instruction?

Inferior or poor design, ambiguous specifications, incomplete or inaccurate WIs and methods, non conformance etc. are the most frequent causes of defects during manufacture or the delivery of a process or service. In order that management can be sure that everything is being carried out under the strictest of controlled conditions, it is crucial that all WIs (in fact any written instruction) are clear, accurate and fully documented. Good WIs avoid confusion and show exactly what work has to be done or what services are to be provided. They also delegate authority and responsibility.
How to write Work Instruction?

Work Instruction as per ISO 9001 :

Without a written guide, differences in policies and procedures can easily arise and these variations can result in confusion and uncertainty. As ISO reminds us: ‘Instructions provide direction to various ISO 9000 levels of personnel. They also provide criteria for assessing the effectiveness of control and the quality of the material, ensure uniformity of understanding, performance and continuity when personnel changes occur. They provide the basis for control, evaluation and review’.

What is work Instruction as per ISO 9001?

Components of a Work Instruction :

In summary, ideally a WI should contain:
  • Document data sheet: All the salient information about the document – file name, who wrote it, a summary of the contents, when it was approved, who approved it and a record of all changes made to the document etc.
  • Contents list: A list of all the chapters, sections, parts and annexes, etc. making up this document;
  • List of annexes: All parts of a document should be traceable, especially when they are in separate volumes;
  • References: A clear reference to any material or technology that is specifically referred to in the document. Also any associated QPs, etc.
  • Scope and objectives: This should define exactly what the WI is needed for. Normally this is a very simple statement because a WI would usually be limited to one process (e.g. the WI illustrated in first figure of this articles detailing the actions to be taken to dig a square hole);
  • Procedure: again, referring to following figure as an example, this will state the manner of production, installation or application where the absence of such controls would adversely affect the quality of the hole to be dug using hand shovels only, and would require temporary shoring to prevent collapse.
  • Consideration should also be given to any safety implications that may exist
  • when carrying out the process.
  • Responsibility: The WI must clearly state who can carry out the process;
  • Relevant forms: The identification of forms – hard copy or computerised required to implement the WI.
What are the components of a Work Instruction ?

How many Work Instructions can I have?

The manufacture of a device or the delivery of a process or service may require the completion of more than one WI. It is perfectly acceptable, indeed desirable, to separate processes into a number of WIs because:
  • It would be very difficult to write a single WI for large items, such as building an aircraft or laying on the catering services for a Tournament;
  • Each WI may require Staff with different levels of training and qualifications;
  • A particular contract may only require the completion of certain WIs;
  • Small, concise WIs are more easily revised.
How many Work Instructions required as per ISO 9001?

0 thoughts on “What is a Work Instruction in ISO 9001?

Leave a Reply

Your email address will not be published.