How To Write ISO 9001 Standards Procedures?

Step 1
Place the following sub sections into your procedure:
Purpose, Scope, Definitions, Associated Documentation, Responsibility/Authority, Procedure, Record Retention and Attachments. Leave blank spaces between each to add the required information.
Step 2
First, start with the Purpose Section. Describe the reason why the procedure exists. If we use the purchasing procedure as an example the Purpose might read:
“This procedure defines the process for obtaining raw materials and supplies for XYZ Company and the matter with which the requirements of these purchases are flowed down to XYZ Company’s suppliers.”
Step 3
ScopeNext, define the scope of the document. This is to what extent the process will reach within the company. For example:
“This procedure shall include all purchases directly used in the manufacture or processing of XYZ Company’s product.”
Step 4
Next make a list of terms and definitions. These should not be common terms that anyone reading the document should already know; but, should be technical terms that pertain to the procedure or common terms that may have added meaning to the company. For example:
“Supplier – XYZ Company defines a supplier as an approved company that supplies items used to produce and/or manufacture our product. This term does not include companies that supply general office product not used to produce or process XYZ Company’s products.”
In this example the common term supplier has added meaning to XYZ Company that could differ from another company’s definition of supplier. To avoid confusion a definition of the term is listed in the definitions section of the ISO 9001 procedure.
Step 5
Define the supporting document that are needed to create a complete process. If you product calls out t use only approved suppliers it may be nice to reference the supplier management procedure and the approved supplier list; because, they will be needed to complete the purchasing process.
Step 6
Now define the responsibilities and authorities. This is similar to a job description where as it defines the person that will manage and/or carry out the tasks described in the procedure. For example:
“The purchasing manager will be responsible for managing this procedure and coordinating purchases. Managing shall include the implementation and enforcement of this procedure throughout XYZ Company.”
Step 7
Define the procedure. This is the bulk of the procedure and is where the company will define the actual process. This can be detailed or simply call out what work inspection are to be used at each step of the purchasing process. It is important that all the elements of the quality standard that pertain to the procedure are defined in this part of the document. This section is usually broken into subsections. In our “Purchasing Procedure” example this might include “General procedures”, “Purchasing Components and Raw Materials” and “Purchasing Outside Services”. Usually some kind of outline method is used to layout this section.
Step 8
Next is the record retention section. This usually defines the method of controlling records related to this process. Where they will be kept, How long they will be kept, in what type of media for which they will be stored.
Step 9
Finally, the attachments section of the procedure will be defined. This will be references to other procedures, external information sources or other media used to supplement that procedure itself.