ISO 9001 Lingo
Social, Legal, Competitors, Markets, Economics
What is external Environment
determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes
What is Clause 4.4.1c
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that customer and applicable statutory and regulatory requirements are determined, understood, and consistently met
What is Clause 5.1.2a
.... prevent, or reduce, undesired effects
What is Clause 6.1.1c
.... identified in order to determine their status..
What is Clause 7.1.5.2b
Need(s) or expectation(s) that is stated, generally implied or obligatory. Shall statements
What is Requirements
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
What is Clause 4.1 p1
.... provides a framework for setting quality objectives.
What is Clause 5.2.1b
.... how to
What is Clause 6.1.2b 1,2
This knowledge shall be maintained and be made available to the extent necessary
What is Clause 7.1.6 p2
§“person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity (of your organization); same as stakeholder EXAMPLE Customers, owners, people in an organization, providers, bankers, regulators, unions, partners, or society that can include competitors or opposing pressure groups.”
What is interested party
To the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned.
What is Clause 4.4.2 b
..... be available to relevant interested parties, as appropriate
What is Clause 5.2.2c
The quality objectives shall be relevant to conformity of products and services and to enhancement of customer satisfaction.
What is Clause 6.2.1d
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system
What is Clause 7.1.1 p1
Set of interrelated or interacting activities that use inputs to deliver an intended result
What is Process
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine the interested parties that are relevant to the quality management system.
What is Clause 4.2.1a
..... ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization.
What is Clause 5.1.1b
When planning how to achieve its quality objectives, the organization shall determine what resources will be required
What is Clause 6.2.2b
The organization shall determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
What is Clause 7.1.3
Activities that feed into a process
What is Inputs
What is Clause 4.4.1
.... the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
What is Clause5.1.2b
The organization shall consider the integrity of the quality management system.
What is Clause 6.3.p1b
.... the implications of not conforming with the quality management system requirements.
7.3.d