It is a common misconception that every process within an organisation (business) must be documented in order to gain ISO 9001 certification. This is simply not the case. With the shift towards risk based thinking, the 2015 revision of the standard is more adaptable than ever before. We’ve put together a list of the required documents for ISO 9001 below
| Policies | Clause |
| Scope of the Quality Management System | 4.3 |
| Quality Policy | 5.2 |
| Quality Objectives and Plans for Achieving Them | 6.2 |
| Procedure for Control of Externally Provided Processes, Products and Services (outsourced processes) | 8.4.1 |
| Records | Clause |
| Record of Maintenance and Calibration of Monitoring and Measuring Equipment | 7.1.5.1 |
| Competence Records | 7.2 |
| Product/Service Requirements Review Record | 8.2.3.2 |
| Record of New Requirements for Product or Service | 8.2.3.2 |
| Design and Development Inputs Record | 8.3.3 |
| Record of Design and Development Controls | 8.3.4 |
| Design and Development Outputs Record | 8.3.5 |
| Record of Design and Development Changes | 8.3.6 |
| Record of Evaluation of External Provider (supplier) | 8.4.1 |
| Record of Product/Service Characteristics | 8.5.1 |
| Record of Changes on Customer’s Property | 8.5.3 |
| Record of Changes in Production/Service Provision | 8.5.6 |
| Evidence of Product/Service Conformity | 8.6 |
| Record of Nonconformity | 8.7.2, 10.2.2 |
| Monitoring Performance Information | 9.1.1 |
| Internal Audit Program and Results | 9.2.2 |
| Management Review Results | 9.3 |
| Nonconformities and Corrective Action | 10.2.2 |
Feeling overwhelmed?