ISO 9001 Documentation requirements

• Free PDCA Guidance
• PLAN your quality system
• DO day-to-day tasks
• CHECK the results
• ACT to improve

• ISO 9000:2005 Principles
• Process approach
• Leadership & people
• Customer focus

• ISO 9001:2008 Base Clauses
• 4.1a - 4.1d Process planning
• 5.1 Management commitment
• 5.3 Quality policy
• 5.2 Customer focus

• ISO 9001:2008 Requirements
• 4.2 Documentation
• 7.1 Process planning
• 6 Resource management
• 5.3.3 Communication
• 6.2 Human resources
• 7.2 Customer processes
• 8.2.1 Customer satisfaction

ISO 9001 quality system documentation requirements:

• Quality policy and quality objectives
• A quality manual
• The procedures specified by ISO 9001
• Other documents required for effective planning, operation and control
• The records specified by ISO 9001

There's an urban myth that procedures must spell out everything in minute detail “..in case someone falls under a bus..”. This is a hangover from the Defence standards and has NEVER been a requirement of ISO 9000.

If you are building nuclear reactors (or if you have a high staff turn-over) it’s a good idea to spell out everything and back-up every decision with a series of checks and signatures.

If you are not in that type of business then do you really need that level of detail?

To paraphrase 4.2.1 Note 2:

• Are we doing simple or complex tasks?
• Are we a large or small company?
• Do you consider that staff are competen ?

The answers to these questions will influence the amount of documentation required.

The modern way of documenting a quality system this is to have lightweight procedures balanced by heavy training records, which demonstrate competence.

Also, think about having flow-charts instead of text. You can draw adequate flow-charts using Word‘s auto-shapes.

Whether you use text or flow-charts, generally aim (in artistic terms) for an impressionist painting, rather than a detailed engineering blue-print.

4.2 Documentation Requirements

Define and document your quality management system (e.g. using a quality manual).

All the mandatory procedures and documentation requirements are explained in our Quality Manual Template and guidance document.

>> View Quality Manual Template sample
>> View guidance document sample

4.2.1 General

• Develop the quality policy document (5.3)
• Develop and establish the quality objectives (5.4.1)
• Develop and establish the quality manual (4.2.2)
• Develop procedures to implement your quality system (4.2.3. 4.2.4, 8.3, 8.2.2, 8.5.2, 8.5.3)
• Develop documents that reflect what your organisation does

Use this documentation hierarchy:

• Level 1: Policies - key system objectives
• Level 2: Quality Manual - approach & responsibility
• Level 3: Procedures - methods (Who, What, Where & When)
• Level 4: Work Instructions - description of processes (How)
• Level 5: Forms, Data & Records - evidence of conformance