SAE AS9100D

SAE INTERNATIONAL AS9100™D Page 17 of 54
The organization shall consider:
a. the capabilities of, and constraints on, existing internal resources;
b. what needs to be obtained from external providers.
7.1.2 People
The organization shall determine and provide the persons necessary for the effective implementation of its quality
management system and for the operation and control of its processes.
7.1.3 Infrastructure
The organization shall determine, provide, and maintain the infrastructure necessary for the operation of its processes and
to achieve conformity of products and services.
NOTE: Infrastructure can include:
a. buildings and associated utilities;
b. equipment, including hardware and software;
c. transportation resources;
d. information and communication technology.
7.1.4 Environment for the Operation of Processes
The organization shall determine, provide, and maintain the environment necessary for the operation of its processes and
to achieve conformity of products and services.
NOTE: A suitable environment can be a combination of human and physical factors, such as:
a. social (e.g., non-discriminatory, calm, non-confrontational);
b. psychological (e.g., stress-reducing, burnout prevention, emotionally protective);
c. physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.
7.1.5 Monitoring and Measuring Resources
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or
measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a. are suitable for the specific type of monitoring and measurement activities being undertaken;
b. are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources.
SAE INTERNATIONAL AS9100™D Page 18 of 54 7.1.5.2 Measurement Traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b. identified in order to determine their status; c. safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification. The organization shall maintain a register of the monitoring and measuring equipment. The register shall include the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria. NOTE: Monitoring and measuring equipment can include, but are not limited to: test hardware, test software, automated test equipment (ATE), and plotters used to produce verification data. It also includes personally owned and customer supplied equipment used to provide evidence of product and service conformity. Calibration or verification of monitoring and measuring equipment shall be carried out under suitable environmental conditions (see 7.1.4). The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. 7.1.6 Organizational Knowledge The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. NOTE 2: Organizational knowledge can be based on: a. internal sources (e.g., intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); b. external sources (e.g., standards; academia; conferences; gathering knowledge from customers or external providers). Competence The organization shall: a. determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; b. ensure that these persons are competent on the basis of appropriate education, training, or experience; c. where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; d. retain appropriate documented information as evidence of competence. NOTE: Consideration should be given for the periodic review of the necessary competence. NOTE: Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons. 7.3 Awareness The organization shall ensure that persons doing work under the organization’s control are aware of: a. the quality policy; b. relevant quality objectives; c. their contribution to the effectiveness of the quality management system, including the benefits of improved performance; d. the implications of not conforming with the quality management system requirements; e. relevant quality management system documented information and changes thereto; f. their contribution to product or service conformity; g. their contribution to product safety; h. the importance of ethical behavior. 7.4 Communication The organization shall determine the internal and external communications relevant to the quality management system, including: a. on what it will communicate; b. when to communicate; c. with whom to communicate; d. how to communicate; e. who communicates. NOTE: Communication should include internal and external feedback relevant to the quality management system. SAE INTERNATIONAL AS9100™D Page 20 of 54 7.5 Documented Information 7.5.1 General The organization’s quality management system shall include: a. documented information required by this International Standard; b. documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE: The extent of documented information for a quality management system can differ from one organization to another due to: 􀃭 the size of organization and its type of activities, processes, products, and services; 􀃭 the complexity of processes and their interactions; 􀃭 the competence of persons. 7.5.2 Creating and Updating When creating and updating documented information, the organization shall ensure appropriate: a. identification and description (e.g., a title, date, author, or reference number); b. format (e.g., language, software version, graphics) and media (e.g., paper, electronic); c. review and approval for suitability and adequacy. NOTE: Approval implies authorized persons and approval methods are identified for the relevant types of documented information, as determined by the organization. 7.5.3 Control of Documented Information 7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure: a. it is available and suitable for use, where and when it is needed; b. it is adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity). 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: a. distribution, access, retrieval, and use; b. storage and preservation, including preservation of legibility; c. control of changes (e.g., version control); d. retention and disposition; e. prevention of the unintended use of obsolete documented information by removal or by application of suitable identification or controls if kept for any purpose. -
SAE INTERNATIONAL AS9100™D Page 21 of 54
Documented information of external origin determined by the organization to be necessary for the planning and operation
of the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alterations.
When documented information is managed electronically, data protection processes shall be defined (e.g.,
protection from loss, unauthorized changes, unintended alteration, corruption, physical damage).
NOTE: Access can imply a decision regarding the permission to view the documented information only, or the permission
and authority to view and change the documented information.
8. OPERATION
8.1 Operational Planning and Control
The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the
provision of products and services, and to implement the actions determined in clause 6, by:
a. determining the requirements for the products and services;
NOTE: Determination of requirements for the products and services should include consideration of:
􀃭 personal and product safety;
􀃭 producibility and inspectability;
􀃭 reliability, availability, and maintainability;
􀃭 suitability of parts and materials used in the product;
􀃭 selection and development of embedded software;
􀃭 product obsolescence;
􀃭 prevention, detection, and removal of foreign objects;
􀃭 handling, packaging, and preservation;
􀃭 recycling or final disposal of the product at the end of its life.
b. establishing criteria for: