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What Are The Documents Required By ISO 9001

What Are The Documents Required By ISO 9001?

What Are The Documents Required By ISO 9001?  The complexity of your ISO 9001 documents is determined by the complexity of your business.  If you have a large company that has many different tasks, you will have to create more documents than if you are a smaller company that only does a few things.  Also, think about it, if you are a large company that does one thing but one thing very well, you might not have as many documents as even a small company that does many tasks.  The level of documents used by each company is based on the needs of that company.  They are all the same documents, however, as the next guy.  You may have some that don’t need as many to complete the level, but that is entirely up to the complexity of your company.

What Are The 6 Documents Required By ISO 9001?

  • Scope of the QMS
  • Quality Policy
  • Quality Objectives
  • Criteria for the evaluation and selection of suppliers
  • Quality Manual (Not mandatory but may be useful)
  • Documented Procedures that were referenced in your manual.

Have professionals assist you with the ISO certification process

What Are The Documents Required By ISO 9001
What Are The Documents Required By ISO 9001

However, there are actually 20 different processes in ISO 9001. Many are not aware that there are so many.  To have your ISO 9001 done properly you need to have the professionals take a look and assist you through this process. While the process looks painful, it actually isn’t that bad with the right help.

To begin working on the process you would start with Records and Forms and work your way up the list.  This is because the predecessors on the list will be calling out those below them.  So, they have to have them made first.  These are the more detailed procedures that you do every day in your business.  The first documents will be far more detailed.

ISO 9001 processes, procedures, and work instructions

Once you have the forms produced. It is time to dive into the ISO 9001 processes, procedures, and work instructions.  But, what is the difference between these terms?

  • Processes explain why and how to get things done.
  • The procedure explains how to use the processes to get things done.
  • Work Instruction is how to carry out the procedure.

Each of these is very intertwined into each other.  The process is a summary of the broad resources, objectives, and specifications.  The procedure is the part of the documents that talk about measurement, responsibilities, methods, and specific tools.  Typically the work instruction is used by the people actually doing the work.  It explains the methods, specific tools used, measurement, and responsibilities.  It explains how to do the work.

The process

The process must be defined by hopefully measurable outputs, objectives, activities, inputs, and resources.  There are many types of processes that are needed for the ISO 9001:

  • Planning processes
  • Operations management processes
  • Documentation processes
  • Resource management processes

This point of having this documentation is to tighten up the processes and have the same results no matter who does the work.  This helps train the people that are doing the work as well as implements workflow that will be consistent each and every time.  This is important to improve productivity and output.  When the proper structure is in place, improvements throughout the company will be noticed.  Often times there will be less management needed in various areas as everything knows what to do according to the processes and procedures.

The procedures.

The procedures will be everything from how you control your suppliers to how you do a certain process.  It things such as:

  • Terminology, explanations, definitions, etc.
  • Information, tools, other resources
  • The requirements or criteria they must meet
  • Where an activity is performed
  • Where the inputs and outputs come from and go
  • Who performs what action
  • How to execute what needs to be accomplished.
  • Explanation of why there is even a procedure in the first place.

ISO 9001 had some changes in 2015 to ensure that too much documentation wasn’t happening, which will muck the waters.  This means that they have removed some of the mandates and replaced them with “Documented information” Simplifying and clarification assists companies that they are in fact ISO certified without going into grave details on all of their procedures.

When writing procedures you want to know the purpose, the responsibilities, definitions, and equipment, and/or software that will be needed.  Things such as reviewing things with the customers and how you communicate with them are key procedures that should be documented.  This ensures that everyone does it the same way.  By having things documented, you can easily train new people to slide in and take over.  This means that there is less cost in training someone then there was without the certification.