ISO 9001:2015 is pretty clear on what documented information is required to conform with the standard. Understanding which clauses require documentation to be retained and/or maintained is the first step in building your quality management system.
To help you with this we have pulled all of the requirements together and made this quick reference table.
*Documented information to be maintained is normally a written procedure on ‘how’ to do something or it is a written statement of fact.
| 4.3 Determining the scope of the quality management system | The scope shall be available and be maintained as documented information |
| 5.2 Policy (5.2.2) | Be available and be maintained as documented information |
| 6.2 Quality objectives and planning to achieve them (6.2.1) | Maintain documented information on the quality objectives |
*Documented information to be retained is considered to be records or evidence that a process has been carried out.
| 7.1.5.1 General (7.1.5 Monitoring and measuring resources) | Retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources |
| 7.1.5.2 Measurement traceability | The basis used for calibration or verification shall be retained as documented information. |
| 7.2 Competence | Retain appropriate documented information as evidence of competence |
| 8.2.3 Review of the requirements for products and services (8.2.3.2) | Retain documented information, as applicable. |
| 8.3.2 Design and development planning | Document information needed to demonstrate that design and development requirements have been met. |
| 8.3.3 Design and development inputs | Retain documented information on design and development inputs. |
| 8.3.4 Design and development controls | Documented information of these activities is retained. |
| 8.3.5 Design and development outputs | Retain documented information on design and development outputs. |
| 8.3.6 Design and development changes | Retain documented information on …. As listed. |
| 8.4.1 General (8.4 Control of externally provided processes, products and services) | Retain documented information of these activities and any necessary actions arising from the evaluations. |
| 8.5.2 Identification and traceability | Retain the documented information necessary to enable traceability. |
| 8.5.3 Property belonging to customers or external providers | Retain documented information on what has occurred. |
| 8.5.6 Control of changes | Retain documented information describing the results of the review of changes… |
| 8.6 Release of products and services | Retain documented information on the release of products and services. |
| 8.7 Control of nonconforming outputs (8.7.2) | Retain documented information that … As listed |
| 9.1.1 General (9.1 Monitoring, measurement, analysis and evaluation) | Retain appropriate documented information as evidence of the results. |
| 9.2 Internal audit (9.2.2) | Retain documented information as evidence of the implementation of the audit programme and the audit results. |
| 9.3.3 Management review outputs | Retain documented information as evidence of the results of management reviews. |
| 10.2 Nonconformity and corrective action (10.2.2) | Retain documented information as evidence of … As listed |
*Some clauses require both documented information to be maintained (processes) and retained (evidence).
| 4.4 Quality management system and its processes (4.4.2) |
Maintain documented information to support the operation of its processes. Retain documented information to have confidence that the processes are being carried out as planned. |
| 8.1 Operational planning and control | Maintaining and retaining documented information to the extent necessary. |
*And then just to keep it interesting ISO 9001:2015 refers to documented information being available for just one clause which is similar to maintaining documented information in this example.
| 8.5.1 Control of production and service provision | The availability of documented information that defines … As listed. |
Now that you can see them listed and separated, an ISO 9001 quality management system isn’t about the number of procedures documented, it’s more about providing the evidence that processes and activities are being conducted as planned. Basically, if you say you are doing something, make sure you have the evidence to prove it.