Clause 4: Context of the Organization

KEY REQUIREMENTS

Determine, monitor and review external and internal issues.
Determine, monitor and review relevant interested parties.
Establish the QMS scope.
Define, evaluate and improve QMS processes.

🚧 LINKED PROCEDURE 4.1.2

4.1 The organization and its context

Triad has determined the external and internal issues that are relevant to the purpose and strategic direction to achieve desired QMS output. The QMS information will be monitored and reviewed. The purpose of the QMS is to provide the framework to, in the simplest definition, identify customer needs, how the organization can meet those needs and finally, how we can ensure repeat business. Strategically, we will maintain the QMS, ensure the contents are understood by all interested parties and monitor for compliance. In doing so, Triad would benefit from repeat business, word of mouth advertising, contribute to the safety of those using the end product and project a responsible company culture that attracts employees who share the same goals.

4.1 Determine external and internal issues

Triad plans to understand everything that can influence the purpose and strategic direction of the company (corporate culture, innovation, market, compliance)

4.1 Monitor and review information about issues

Determine what risks/opportunities exist specific to issues identified

4.2 Needs and expectations of interested parties

Triad will consistently provide products and services that meet customer and applicable statutory and regulatory requirements. To do this we shall determine, monitor and review information during Management Review and the quote process.

4.2 a Identify interested parties

Business purpose = creating customers

4.2 b Clarify the requirements of interested parties

Each interested party will have unique needs/expectations - determine if long-term partnership is possible

4.2 Monitor and review information about interested parties and their requirements

This is to be done BEFORE proceeding with a quote or accepting an order

4.3 Scope of the QMS

The QMS applies to all activities within Triad as a contract, electronic manufacturer of printed circuit boards and associated integrated systems (cables, wires, boxbuild) to include services such as test and conformal coating. Design and development services are excluded.

4.3 Define the scope of the QMS

Make available to interested parties

4.3 a Account for external and internal issues

See 4.1

4.3 b Account for the requirements of interested parties

See 4.2

4.3 c Account for the products and services

All products and services in scope by Triad without exception

4.3 Apply any requirement of ISO 9001 applicable within the scope of the QMS

The standards become internal requirements

4.3 Maintain the scope of the QMS as documented information

See 7.5; include all products and services

4.3 Include in the scope of the QMS justification for any requirements that cannot be met

Detail exclusions - please refer to scope as referenced in the SCOPE section of the QMS (clause 1).

4.4 QMS and Its Processes

4.4.1 Triad has established, implemented, maintained and strives to continually improve their QMS including processes and interactions, according to the standard requirements.

4.4.1 Establish, implement, maintain and improve a process-based QMS

4.4.1 Determine the required/necessary processes and how they will be applied

4.4.1 Address customer and regulatory requirements

See 8.2.2

4.4.1 a Determine process inputs/outputs

Process sheet or PEAR

4.4.1 b Determine sequence and interaction of processes

Flow chart or diagram

4.4.1 c Determine the criteria and methods to control processes

4.4.1 d Determine and ensure the resources

See 7.1

4.4.1 e Assign responsibilities and authorities

Job description/KRA

4.4.1 f Account for the risks and opportunities of each process

See 6.1

4.4.1.g Evaluate the processes and if necessary modify them

Identify methods to monitor, measure, check and modify processes. See 9.1.1

4.4.1 h Determine the improvement opportunities of processes and the QMS

See 10.1

4.4.2 Triad shall maintain documented information to support operation of its processes and retain the same to ensure processes are carried out as planned.

4.4.2 a Maintain documented information on process operation

See 7.5 (process map)

4.4.2 b Retain documented information on process operation

See 7.5

4.4.2 Establish and maintain documented information that includes a general description of relevant interested parties

4.2.a

4.4.2 Establish and maintain documented information that includes the scope of the QMS

4.4.2 Establish and maintain documented information the includes the sequence and interaction of these processes

4.4.1.b

4.4.2 Establish and maintain documented information that includes responsibilities and authorities for these processes

4.4.1.e

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