Determine and provide resources needed to support the QMS.
Ensure employees are competent in their job functions and aware of relevant QMS related information.
Develop an internal and external communication plan.
Control documented information that is required by AS9100, our organization and the customers.
7.1.1 General
Triad has determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS. Triad shall consider capabilities and contraints on existing internal resources and what needs may be met by external providers.
7.1.1 Provide the necessary resources
7.1.1 a Review existing resources
Review capabilities and constraints
7.1.1 b Account for the need of external providers
In the event a service is not available from Triad
7.1.2 People
Triad has determined and provided the people necessary for the effective implementation of its QMS and for the operation and control of its processes.
7.1.2 Provide suitable people for the effective operation of the QMS and its processes
7.1.3 Infrastructure
The infrastructure as defined below is maintained for the operation of its processes and to achieve conformity and products and services.
7.1.3 Provide and maintain the infrastructure necessary to the functioning of processes
buildings, equipment, transportation, hardware, software
7.1.4 Process environment
The environment is maintained for the operations of its processes and to achieve conformity of products and services. This may be a combination of human and physical factors.
7.1.4 Provide and maintain the suitable environment necessary to the functioning of processes
Corporate culture, work atmosphere, temperature, ergonomics
7.1.5 Monitoring and measuring resources
7.1.5.1 General
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 defined by the customer. Triad ensures the resources are suitable for the type of activities required and are maintained to ensure fitness.
7.1.5.1 Provide suitable monitoring and measuring resources
To obtain expected inspection results
7.1.5.1 a Provide adequate resources to the specific inspections
See 7.2
7.1.5.1 b Maintain resources
In order to ensure fitness for their purpose
7.1.5.1 Retain documented information on the adequacy of inspection resources
7.5
7.1.5.2 Measurement Traceability
When measurement traceability is a requirement or considered to be an essential part of validating measurement results, equipment is calibrated and/or verified to industry standards. If no standards exist, the justification for validation shall be disclosed. A calibration schedule is maintained by asset in Accelo.
7.1.5.2 a Verify or calibrate regularly the measuring equipment
Applies to results obtained with measuring equipment; otherwise, retain documented information on the reference used, see 7.2
7.1.5.2 b Identify the measuring equipment
Calibration schedule by individual asset requiring as such
7.1.5.2 c Protect the measuring equipment
7.1.5.2 Conduct corrective action on previous measurement results
When a measuring instrument (equipment) is not in conformity
7.1.5.2 Establish, implement and maintain a process for the recall of monitoring and measuring equipment
Calibration schedule by individual asset requiring as such
7.1.5.2 Maintain a register
Ability to query Accelo for all active assets, and select the tag 'calibration required'
7.1.5.2 Include in the 'register' specific equipment data
Item, ID, location, method of calibration/verification, frequency, acceptance criteria - this data is included in the asset details
7.1.5.2 Ensure suitable environmental conditions for carrying out calibration or verification
See 7.1.4
7.1.6 Organizational Knowledge
This is knowledge specific to Triad and necessary for the operation of our processes and to achieve conformity. This knowledge is maintained and made available only to the extent necessary. When addressing changing needs and trends, Triad shall consider its current knowledge and determine if additional knowledge or updates are required.
7.1.6 Determine the necessary knowledge
7.1.6 Acquire, maintain and make organizational knowledge available to the extent necessary
7.1.6 Account for the need of additional knowledge
Triad shall determine the necessary competence for both new hires and existing employees, specific to the work assigned and under their immediate control. Triad ensures periodic reviews occurs of said competence and takes actions when necessary to evaluate or address evidence of non-compliance.
7.2 a Determine the necessary competence
Clarify quality competence requirements
7.2 b Ensure the competence
Based on appropriate training or experience
7.2 c Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities
Training, coaching, external education
7.2 d Retain documented information on competence
See 7.5
Triad ensures all persons employed or aware of the quality policy, how to access it electronically, and their contribution and role to the sub-clauses below.
7.3 a Ensure the staff is aware of the quality policy
To include sub-contractors
7.3 b Ensure staff is aware of quality objectives
See 6.2
7.3 c Ensure staff is aware of their contribution
7.3 d Ensure staff is aware of negative impacts
7.3 e Make staff aware of QMS documented information
See 7.5
7.3 f Make staff aware of their contribution to product or service conformity
See 9.1.2
7.3 g Make staff aware of their contribution to product safety
See 8.1.3
7.3 h Make staff aware of the importance of ethical behavior
Triad shall determine the internal/external (feedback) communications necessary to support the QMS as referenced below:
7.4 a Define the subjects on which to communicate
Internally/externally
7.4 b Define when to communicate
Respond quickly to claims
7.4 c Define with whom to communicate
Communication both ways
7.4 d Define how to communicate
Orally, Writing, Internet, Video
7.4. e Assign who will communicate
The responsible party who has authority that is directly related to the subject at hand
7.5.1 General
Triad shall retain documented information required by the standards and determined necessary as evidence of compliance to product requirements and the effectiveness of the QMS.
7.5.1 a Include the documented information required by the ISO/AS9100 standard.
7.5.1 b Select the documented information deemed necessary to the effectiveness of the QMS
7.5.2 Creating and updating
When creating or updating documents, Triad ensures appropriate identification or description, format and review by the QMS representative and area owner.
7.5.2 a Create, identify and describe the documented information
Logo, Title, REV Date
7.5.2 b Choose the format and media
Language, paper or electronic
7.5.2 c Review and approve the adequacy of the documented information
Who can author or request change; who approves
7.5.3 Control of documented information
As indicated below, documented required by the QMS and standards shall be controlled to ensure it is available for use, protected and controlled. When documented information is managed electronically, data protection processes are defined.
7.5.3.1 a Control the availability of the documented information
Where is it located and is it available for use or review
7.5.3.1 b Control the protection of the documented information
To maintain confidentiality, integrity and prevent misuse
7.5.3.2 a Control the distribution, access and use of the documented information
Who is in charge, method to use, rules to follow
7.5.3.2 b Control the storage of the documented information
7.5.3.2 c Control the changes of the documented information
Use of updated REV, restrict access to obsolete versions
7.5.3.2 d Control the retention time and the removal of the documented information
Retention period, disposal method
7.5.3.2 e Prevent unintended use of obsolete documented information
Remove, place out of access or mark as 'obsolete'
7.5.3.2 Control the documented information of external origin
Artifact control, ITAR controls - unique ID, control access
7.5.3.2 Protect the documented information
Who has the right to read or edit
7.5.3.2 Define a process for the protection of documented information in electronic form
Backups, change rights