AS 13100:2021 pdf – AESQ Quality Management System Requirements for Aero Engine Design and Production Organizations.
7.31 Human Factors Awareness- Supplemental Requirements
The organization ( shall provide an appropriate program of training and awareness of Human Factors based on role, see RM13010
7.4 Communication
Reference 9100D:0912016 requirements.
7.5 Documented Information
7.5.1 General
Reference 9100D:0912016 requirements.
75.2 Creating and Updating
Reference 9100D:09/2016 requirements. Creating and Updating Documented Information – Supplemental Requirements.
When creating and updating documented information, the organization shall record, date and ensure traceability to a responsible person making the change (e.g., name. signature, stamp, electronic signature), with a permanent marking method and the original information being legible and retrievable after the change.
Documented Information such as records shall not be altered without proper traceable documented information permitting the alteration.
Documented information requiring submission or approval by the customer shall be written in English. unless otherwise specified by the customer.
Where documented information contains reference to units of measure then they are to be recorded in the same units of measure as defined on the Product Definition.
7.5.3 Control of Documented Information Reference 9100D:0912016 requirements. Reference 9100D:091201 6 requirements. Documented Information Retrieval Timescales – Supplemental Requirements
The organization shall ensure that documented Information (data) required for review is available for the customer, the customer’s customer. and!or Regulatory Agency within 3 working days of notification.
In the case of an onsite visit, actual documented information (data) shall be made available withii 24 hours, unless the required documented information (data) is located offsite. then the organization needs to make every effort to retrieve the data as soon as possible, but no later than 3 working days.
The delivery of documented information (data) to the customer. etc., does not release the organization from any requirements herein with respect to that documented information (data) except as agreed to in writing by the customer, etc. The organization shall inform the customer immediately and confirm in writing when damage to documented
information of the design and development output under their responsiblhity occurs or following termination of activity. Documented Information Retention Periods – Supplemental Requirements
Unless otherwise specified by the customer documented information shall be retained from the date of manufacture for the time periods defined in Table 8. Product Safety – Supplemental Requirements
The organization shall report to the Customer. Original Equipment Manufacturer (OEM), or Engine Type Certificate Holder within 24 hours of verification. anythmg that can affect the product’s safe and reliable operation identified at any stage In the product’s life.
The OEM or Engine Type Certificate Holder is responsible for making the final judgment on whether there is an actual risk to safe and reliable operation.
8.1.4 Prevention of Counterfeit Parts
Reference 9100D:09/2016 requirements. Prevention of Counterfeit Parts – Supplemental Requirements
The organization shall plan, implement, and control counterfeit part prevention processes in accordance with AS61 74 or AS5553. as applicable.
The organization shall ensure that the counterfert part prevention process includes a mechanism for reporting counterfeit parts to the customer purchasing representative within 24 hours of it being confirmed.
8.2 Requirements for Products and Services
8.2.1 Customer Communication
Reference 91 OOD:09/201 6 requirements, Customer Communication – Supplemental Requirements
The organization shall only accept privileges, agreements, and instructions in writing (e.g., Interface Documents, purchase order, purchase order supplements/amendments), Verbal agreements and instructions shall not be construed as customer approval or authorization.
ibe organization shall agree with the customer the method of formal communication (e.g.. for approval, authorization, agreement) to be used and the applicable traceability requirements such as proforma, coordination memorandum, etc.
The organization shall provide access to data within OASIS and Nadcap databases (e.g., registration documentation, certification, audit reports and findings, corrective actions) to its customers.