Mandatory Procedures For ISO 9001

Imagine you have a business making widgets and at the heart of your processes is a room full of highly trained employees who perform ten complicated functions to transform raw products into the best widgets in the world. They’re your top fabricators.

Then, suddenly a global pandemic occurs. The demand for your widgets is higher than ever and all of the top fabricators are incapacitated. Where would you turn? Panic is not an option.

While the 2020 Covid-19 pandemic may not have had a significant effect on your actual business, it underscored the importance of having in place both written documentation of procedures and a plan for continuity of operations. 

If you had written procedures and continuity of operations plan, then you might just need to sanitize the workspace, hire some healthy people capable of following directions, train them, and put them to work. Or, if hiring people were not an option, you might need to have identified in advance personnel who could be reassigned to the fabrication room.

While ISO 9001:2015 doesn’t explicitly require much documentation, written procedures are necessary to prove to auditors that your business can continue despite potential disruptive factors. And, of course, they’re necessary to keep your business running when actual disruptions occur.

A good place to start with documentation is the list that was required by the 2008 version of ISO 9001. The six mandatory procedures requiring documentation under ISO 9001:2008 were:

  •     Control of documents
  •     Control of records
  •     Internal audits
  •     Control of non-conforming products
  •     Corrective action
  •     Preventive action

Processes, Procedures, And Work Instructions

Additional procedures vary from one organization to another. Procedures may be considered in the middle of a three-part hierarchy, even though sometimes these are blended into just two parts or a single item. Generally, a process is a strategy while a procedure is a uniform method for executing a specific aspect of the strategy. Work instructions provide guidance to an individual on their role in carrying out a procedure or part of a procedure.  

In writing procedures, Cavendish Scott recommends that several factors be considered, though not all apply to every procedure. These include:

  1.     The purpose of the procedure and how it fits into the process of which it is a part.
  2.     Who and what is involved in the procedure
  3.     The qualifications and role of each person
  4.     The machinery, equipment, and tools used and how they are used, along with detailed specifications
  5.     What resources are used, how they are used, and how they are changed through the procedure
  6.     What the product is
  7.     Where the procedure is performed
  8.     The standards required of the resources and final products
  9.     A glossary of terms

 Redundancy is an important aspect of continuity of operations, so it’s also helpful to have some backup for the procedures. These may include the following factors, which can be included in the procedures:

  •     Forms
  •     Controls
  •     Organization
  •     Specific personnel

Procedures Exist Only If They’re Written

You may be tempted to forego written procedures and rely only on backups, but Cavendish Scott recommends against that. Nothing is as reliable as having written procedures and not having a written procedure is the fastest way to lose certification. The firm takes the stand that if a procedure is not in writing it doesn’t exist.

Writing procedures is consistent with the approach to business processes promulgated by William Edwards Deming and followed by Cavendish Scott. It is not only about being good but being good all the time.

Cavendish Scott offers consulting, training, and auditing to help organizations obtain and maintain certification in a full range of standards. Additional information is available at cavendishscott.com.

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