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ISO 9001:2015 Quality Manual Guide

This document is the quality manual for XXXX 1509001:2015. It establishes and describes the quality management system to consistently provide products that meet customer and legal requirements and to continuously improve customer satisfaction and performance. The quality management system is based on process approach, the plan-do-check-act cycle, and risk-based thinking to understand internal and external contexts and meet stakeholder needs and expectations. It references the ISO 9000 standards for quality management systems and defines key terms used in the quality system such as processes, risks, and interested parties.

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Adhi Gunanto
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437 views1 page

ISO 9001:2015 Quality Manual Guide

This document is the quality manual for XXXX 1509001:2015. It establishes and describes the quality management system to consistently provide products that meet customer and legal requirements and to continuously improve customer satisfaction and performance. The quality management system is based on process approach, the plan-do-check-act cycle, and risk-based thinking to understand internal and external contexts and meet stakeholder needs and expectations. It references the ISO 9000 standards for quality management systems and defines key terms used in the quality system such as processes, risks, and interested parties.

Uploaded by

Adhi Gunanto
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Logo Reviewed by:

XXXX 1509001:2015 Quality Manual Approved by:


Version :

1.Scope
XXXX esta blish, implement a nd maintain this IS09001:2015 QMS to consistently provide products that meet

customer a nd a pplicable lega l requirements, a nd to continuously improve customer's satisfaction and the

performance of QMS. We strive to understand the dyna mic external a nd internal context,and the cha nging

need & ex pectation of releva nt interesting parties,to identify and address the risks & opportunities, by

utilizing process approach,POCA a nd risk-based thinking,data a nalysis and qua lity management principles.

2. Normative reference
ISO 9000:2015,Quality management systems - Fundamentals a nd voca bulary

• Characteristic - A cha racteristic is a distinctive feature or property of something.


• Context of the organization - a ll of the interna l and external factors a nd conditions that affect its products
a nd services,have an influence on its QMS, a nd a re relevant to its purpose and strategic direction.
• Correction - a ny action that is ta ken to eliminate a nonconformity,but to address root ca uses.

• Corrective action- steps that a re ta ken to eliminate the ca uses of existing nonconformities in order to

prevent recurrence of the existing nonconformities and potentially undesira ble situations .

• Interested party - anyone who ca n affect, be affected by,or believe that they a re affected by a decision or
activity. It is a person, group,or orga nization that has a n interest or a stake in a decision or activity.
• Outsource - when a n outside orga nization to perform pa rt of a function or process of orga nization .
• Process approach - manage a nd control the processes that make up their organization, the interaction
beeen these processes, a nd the inputs and outputs that tie these processes together.
• Process-based quality management system - using process a pproach to manage a nd control how its
quality policy is implemented a nd how its qua lity objectives a re achieved . A process-based QMS is a neork
of interrelated a nd interconnected processes.
• Quality - the degree to which a set of inherent cha racteristics fulfills a set of requirements of an objective .
• Risk - the "effect of uncerta inty on an expected result" a nd an effect is a positive or negative deviation
f rom what is expected.
• Risk-based thinking refers to a coordinated set of activities and methods that orga nizations use to manage
a nd control the many risks that affect its ability to achieve objectives .

3. Terms and definitions


'P urchased Product' is replaced by 'Externa lly Provided Processes, P roducts a nd Services'

Quality is about processes and Quality is shared


data responsibility within an
Page t
organization

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