Mark Hammar With the release of AS9100 Rev D, the term “documented procedure” has been removed; however, this does not mean that no documentation is required for your aerospace Quality Management System (QMS). This new standard includes requirements for many different pieces of “documented information,” the new term for documented procedures and records, but how many documents are required? You can find out more about how documented information works in this article on A new approach to document and record control in AS9100.
Below you will find a list of what documentation is mandatory for AS9100 Rev D, as well as some additional information that is commonly documented in companies:
Mandatory documents and records required by AS9100 Rev D
If you are creating only the documentation required by AS9100 Rev D, this is what you will need to create. (Note: some documents are only necessary if a company performs the relevant processes.):
- Scope of the QMS (clause 4.3)
- General description of relevant interested parties, QMS scope including boundaries and applicability, description of QMS processes and applications, sequence and interaction of QMS processes, assignment of responsibilities and authorities for QMS processes (clause 4.4.2)
- Quality policy (clause 5.2)
- Quality objectives and plans to achieve them (clause 6.2)
- Procedures for control of externally provided processes, products and services (clause 8.4.1)
- Process for control of non-conforming products and services (clause 8.7.1)
- Process for nonconformity and corrective action management (clause 10.2.1)
As well as these documents, the following mandatory records are also needed. (Note: records marked with * are only mandatory when the relevant clause is part of the QMS.):
- Evidence that QMS processes are carried out as planned (clause 4.4.2)
- Monitoring and measuring equipment maintenance and calibration records* (clause 7.1.5.1)
- Records of employee competence (clause 7.2)
- Product/service requirements review records (clause 8.2.3.2)
- Records of new requirements for products and services (clause 8.2.3.2)
- Design and development inputs records* (clause 8.3.3)
- Design and development controls records* (clause 8.3.4)
- Design and development outputs records* (clause 8.3.5)
- Design and development changes records* (clause 8.3.6)
- Characteristics of products and services (clause 8.5.1)
- Record of results of production process validation (clause 8.5.1.3)
- Records to provide traceability* (clause 8.5.2)
- Records about customer property (clause 8.5.3)
- Records of changes in controls for production/service provision (clause 8.5.6)
- Evidence of product/service conformity and release (clause 8.6)
- Record of nonconforming outputs (clause 8.7.2 & 10.2.2)
- Monitoring performance information (clause 9.1.1)
- Internal audit program and records (clause 9.2.2)
- Records of the management review (clause 9.3)
- Records of corrective actions (clause 10.2.2)
Non-mandatory, but common documents
Of course, different companies will need to create different documents to meet their needs, but this list includes many commonly used documents to consider:
- Procedure for determining context of the organization and interested parties (clauses 4.1 & 4.2)
- Procedure for addressing risks and opportunities (clause 6.1)
- Competence, training and awareness procedure (clauses 7.2 and 7.3)
- Procedure for control of documents and records (clause 7.5)
- Operational risk management procedure (clause 8.1.1)
- Configuration management procedure (clause 8.1.2)
- Sales procedure (clause 8.2)
- Procedure for design and development (clause 8.3)
- Procedure for production and service provision (clause 8.5)
- Warehousing procedure (clause 8.5.4)
- Procedure for monitoring customer satisfaction (clause 9.1.2)
- Internal audit procedure (clause 9.2)
- Management review procedure (clause 9.3)
This is the complete list; so, do you think it is too much to write? Can you cover all aspects of your QMS with these documents, or will you need more? You might want to start with documenting the minimum, and then add to it when you find it is necessary; documentation of the QMS is not always the best way to ensure consistency.
Download a free preview of the AS9100 Premium Documentation Toolkit to see the structure for each document mentioned above.
