To determine and establish the scope of the QMS, Triad determined the boundaries and applicability of the QMS, considered the external and internal issues, the requirements of relevant interested parties, and the products and services we provide.
Triad applies all the requirements of ISO 9001 v 2015 and AS9100 D when they are applicable within the determined scope of the QMS. Specific AS9100D requirements are in italicized, blue text.
🚧 Triad applies all the requirements of ISO 13485 when they are applicable within the determined scope of the QMS. At current, Triad's role undertaken under the applicable International Standard and regulatory requirements is Authorized Representative.
Specific ISO 13485 requirements are in italicized, green text.
Statement of Scope:
The scope of the QMS includes the product and service categories associated with the primary functions of contract electronic manufacturing to include materials procurement, box build and system integration services, manufacturing engineering support, surface mount technology, thru-hole and mixed technology equipment and capabilities. This includes all production occurring at 3120 North 34th Drive, Phoenix, AZ 85017 and distribution direct to customers.
Conformity to any of the aforementioned International Standards may only be claimed if the requirements determined as not being applicable do not affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. In the event that any requirement is not applicable at Triad, justification must be documented.
Triad has determined that the following requirement is not applicable to the operations, is deemed out of scope and is therefore excluded. Justification as follows:
8.3 Design & Development
This exclusion is justified in that no design of product is undertaken by Triad; production occurs based solely on the design and development of the product owners and that data they provide. Any reference in the QMS to 'engineering' is referring to process engineering rather than product engineering. Product owners are not obligated to share product end-use or purpose with Triad at any time during the production process.
4.2.3 Medical Device File
This exclusion is justified in that Triad is not the manufacturer of record for any medical device currently assembled on site.
7.3 Design & Development
This exclusion is justified in that no design of product is undertaken by Triad; production occurs based solely on the design and development of the product owners and that data they provide. Any reference in the QMS to 'engineering' is referring to process engineering rather than product engineering. Product owners are not obligated to share product end-use or purpose with Triad at any time during the production process.
7.5.4 Servicing Activities
This exclusion is justified in that at current, no servicing is being conducted of medical devices. Service requests and complaints are directed to the manufacturer of record.
7.5.5 Particular Requirements for Sterile Devices
This exclusion is justified due to at current, Triad is not contracted to manufacture or assemble any medical device classified as a sterile device.
7.5.7 Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
This exclusion is justified due to at current, Triad is not contracted to manufacture or assemble any medical device classified as a sterile device requiring a sterile barrier system.
7.5.9.2 Particular Requirements for Implantable Medical Devices
This exclusion is justified due to at current, Triad is not contracted to manufacture or assemble any medical device classified as an implantable medical device.