ISO 9001:2008 Documentation Requirements

The Standard requires that you document the following: (highlighted items offer definition)

1. Quality Manual
2. Quality Policy
3. Quality Objectives
4. Quality Records
5. Six Procedures
   1. Control of Documents (4.2.3)
   2. Control of Records (4.2.4)
   3. Internal Audit (8.2.2)
   4. Control of Nonconforming Product (8.3)
   5. Corrective Action (8.5.2)
   6. Preventive Action (8.5.3)

How Much Documentation Do You Need?

Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business.

The ISO/IAF Guidelines says: "The auditee/auditor considers that each clause or
sub-clause of ISO 9001 must be defined as a separate process".

Do you purchase anything that could have an impact on meeting the customers' requirements? Then you'll need a Purchasing Procedure to describe section 7.4 - yet that isn't "required".

There are actually 20 different processes called out in the standard. The 9000 Store has designed clearly written procedures to describe each section of the standard. That is why our QMS is better than the rest - we cover the entire standard. Don't think you can only provide a few procedures and call it a QMS. Is it worth the savings?

How do I set up my Documentation?

If you look at this pyramid, the lower the items are - the more specific they are to your business. The higher levels (QM, Proc) are dictated by the standard and are thus fairly common from one ISO 9001 company to the next.

• The Quality Manual describes the quality management system
• Procedure describe a process (Purchasing)
• Work instructions describe an activity within a process (Creating a Purchase Order)
• Forms record the actions of an activity or process
  • NOTE: A record is a completed form/Table/etc. that prove the action took place.
    

What Procedures & Forms are required?

• Required ISO 9001 Procedures
• Required ISO 9001 forms and records

Do I need Procedures and Flow Diagrams?

No. Written procedures are more informative and much easier to edit than flows. Sometimes editing flow charts can be tedious - you're often better off creating them yourself.
Read about ISO 9001 flowcharts

You are required to have a diagram of your overall processes, and we recommend using software like SmartDraw to create them. You can download a free sample and try it for yourself.