8.1 - Operational planning and control

Andy Nichols · Feb 15, 2021

NISHITH NEEMA said: ↑

(The organization must plan, document, implement and control processes needed to meet the requirements of the service provision)

I’m stuck I don’t understand what I need to provide as evidence or what I have to create.
Mr.Gilbert From a manufacturing and service organisation this can help you
Clause 8.1Operational Planning and Control
The organization plans, implements and controls the processes needed to meet the requirements for the
provision of products and services, and to implement the actions taken to addresses risk and opportunities.
1) Org. determines the requirements for products and processes in accordance with the QMS,
Quality Management System .
2) Each department determines the requirements for the products and services by making "Departmental Quality
Management System" in which the implementation items of the department and there interfaces are shown
clearly and the basics of quality planning is clarified.
a) Organization determines , plans and meets the requirements for products and services during new model
phase & Mass production Phase , the new model prepares the , manufacturing management plan
(build - up plan), identifying quality objectives & requirements for the new product and services , promote
activities to ensure conformity with the required quality requirement.
b) The manufacturing sections establishes process quality control items, inspection and test
activities specific to the new product & the criteria for new product acceptance.
c) New product realization activities are implemented in accordance with the Manufacturing management
plan & records needed to provide evidence that product meets requirements are maintained.
3) Manufacturing sections prepare Quality Plan which includes measurement plan and criteria such as :
PQCT, Operation Standards. PQCT and operation standards are used as tool to ensure the built in quality
in process.
4) Org. determines the resources needed to achieve conformity to the product and service requirement
through project planning & budgeting. In case a new project is initiated, not planned in original
fiscal year plan, resources are allocated for the same & budget is approved.
5) For control and effectiveness of the manufacturing processes , measurement at regular frequency of
equipments and system in accordance with the criteria are planned and implemented.
by departments based on process control requirements. Monitoring of identified process parameters is done
by the respective department.
6) Documents are determined, maintain and retained as appropriate to have confidence that the processes have
been carried out as planned and to demonstrate the conformity of products and services to their requirements.
7) The Org. controls planned changes and review the consequences of unintended changes, take action
to mitigate any adverse effect through internal reviews by top management.
Click to expand...

I think this is much too complicated, compare to what ISO 9001 actually requires.

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8.1 - Operational planning and control

Andy Nichols Moderator Staff Member

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8.1 - Operational planning and control

Andy Nichols Moderator Staff Member

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