ISO 9001 Documentation Pyramid

 

ISO 9001 Documentation systems are usually structured in pyramid shape with three or four levels of documentation (For those who like a 4 level pyramid, separate procedures and instructions). The pyramid is used to show that the quality manual is as small portion of the overall documentation but it is very important. The bulk of any documentation system is the records that are compiled over years of service.

Tier 1 - The Quality Manual

The top tier is the quality manual, which contains:
- Statements about management’s commitment to quality
- Quality Policies
- Information about responsibilities for quality related processes
- It should also contain a list of tier-2 quality documents and how to locate them.
- The manual also may contain high-level information about key areas of the quality system like documentation and design control.

The quality manual should be developed with a sufficient level of detail that it describes the system without a level of detail that would create frequent revision changes. The quality manual is frequently distributed to customers and suppliers so revision changes are expensive.

Tier 2 - Procedures and Instructions

Tier-2 of the ISO 9001:2008 Documentation pyramid is the bulk of the quality procedures, standard operating procedures (SOPs), work instructions and explains detailed responsibilities for process control. These documents should be revision controlled using some kind of central system and should require an engineering change order (ECO) to alter the document. Examples of tier-2 procedures include how to build and test products, Details of customer interface procedures, and how to maintain calibration and maintenance records.

(Some people use a 4 tier pyramid with separate instructions and procedures. Both procedures and work instruction are managed using the same ISO 9001 documentation system. The only difference is the level of detail.)

Tier 3 - Quality Records

Tier-3 consists of quality records. Most of the quality records are generated based on tier-2 procedures. Quality records include customer specifications, order processing paperwork or records, incoming inspection records, and product test results. These records are not controlled using the ECO process. They are records that should be accurate in their description of the work completed. Quality records must be maintained to prove compliance to the standard. The duration for maintaining records is usually defined in the quality manual.