AS9100 Rev D Documentation Requirements
AS9100 Rev D, no longer uses the term “documented procedure”, as was used in AS9100 Rev C. However, this does not mean that documentation is not required for your aerospace Quality Management System (QMS). AS9100 Rev D, requirements for creating an aerospace Quality Management System (QMS), follows the ISO 9001:2015 standard in the use of the term “documented information.” This does not mean that there are no more requirements for controlling documents, instead the new requirement is intended to cover both documents and records.
Mandatory Documents for AS9100 Rev D
To help your organization compile a list of mandatory documents, this is what you will need to create. Note that some documents are only necessary if a company performs the relevant processes.
- Clause 4.3: Scope of the QMS
- Clause 4.4.2: 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 5.2: Quality policy
- Clause 6.2: Quality objectives and plans to achieve them
- Clause 8.4.1: Procedures for control of externally provided processes, products, and services
- Clause 8.7.1: Process for control of non-conforming products and services
- Clause 10.2.1: Process for nonconformity and corrective action management
Mandatory Records for AS9100 Rev D
Below is the list of mandatory records for AS9100 Rev D. Many of these records are only mandatory when the relevant clause is part of the QMS, which is designated by an asterisk (*).
- Clause 4.4.2: Evidence that QMS processes are carried out as planned
- Clause 188.8.131.52: Monitoring and measuring equipment maintenance and calibration records*
- Clause 7.2: Records of employee competence
- Clause 184.108.40.206: Product/service requirements review records
- Clause 220.127.116.11: Records of new requirements for products and services
- Clause 8.3.3: Design and development input records*
- Clause: 8.3.4: Design and development controls records*
- Clause 8.3.5: Design and development outputs records *
- Clause 8.3.6: Design and development changes records*
- Clause 8.5.1: Characteristics of products and services
- Clause 18.104.22.168: Record of results of production process validation
- Clause 8.5.2: Records to provide traceability *
- Clause 8.5.3: Records about customer property
- Clause 8.5.6: Records of changes in controls for production/service provision
- Clause 8.6: Evidence of product/service conformity and release
- Clause 8.7.2 & 10.2.2: Record of nonconforming outputs
- Clause 9.1.1: Monitoring performance information
- Clause 9.2.2: Internal audit program and records
- Clause 9.3: Records of the management review
- Clause 10.2: Records of corrective actions
What is Documented Information?
Documented information is any significant data that the organization is required to control and maintain, along with the medium on which it is contained.
In essence, “documented information” refers to the Quality Management System (QMS) and its processes, documentation, and records.
The requirements for documented information are captured in Section 7.5 of AS9100 Rev D and include many of the same requirements that were in the previous version (Rev C) for controlling documents and records. The QMS must still include documented information that is required by the standard, along with documented information that your organization has determined to be necessary for the effectiveness of the QMS. Processes to control documented information also need to consider the size of the organization and type of activities, the complexity of processes and interactions, and the competence of personnel.
In addition to which documents and records are required, there are also requirements around creating and updating documented information. Your organization will need to have control over identification, appropriate format, and review and approval of documented information. In addition, you will also need to have controls over adequate protection, applicable distribution, access, retrieval, use, storage, preservation, control of changes, retention, and disposition, and particularly, prevention of unintended use of obsolete documented information.
The requirements around documentation for AS9100D are nearly the same as AS9100C, but rather than having them separated into documents and records, they have been made into one set of requirements.
Non-Mandatory Common Documents
In addition to the mandatory documents and records, many organizations use the following set of documents and records as well.
- Clauses 4.1 & 4.2: Procedure for determining context of the organization and interested parties
- Clause 6.1: Procedure for addressing risks and opportunities
- Clauses 7.2 and 7.3: Competence: training and awareness procedure
- Clause 7.5: Procedure for control of documents and records
- Clause 8.1.1: Operational risk management procedure
- Clause 8.1.2: Configuration management procedure
- Clause 8.2: Sales procedure
- Clause 8.3: Procedure for design and development
- Clause 8.5: Procedure for production and service provision
- Clause 8.5.4: Warehousing procedure
- Clause 9.1.2: Procedure for monitoring customer satisfaction
- Clause 9.2: Internal audit procedure
- Clause 9.3: Management review procedure