Qms Flashcards
A structured system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements
Also defined as a collection of business processes that focus on meeting customer requirements on a consistent basis
Quality Management System
It is a brief statement that outlines an organization’s overall purpose and mission and supports its strategic direction
Quality Policy
These are measurable goals that stem directly from the quality policy
Quality Objectives
Documents the scope of the QMS, including the organization’s objectives, expectations, policies, processes, and requirements for an organization to comply with ISO, FDA, and other regulatory standards
Quality Manual
A QMS outlines the roles and responsibilities of the key stakeholders, resources, and infrastructure needed to achieve an organization’s quality objectives
Organizational Structure and Responsibilities
An organization should identify and define processes that require any type of resource to transform inputs and outputs
Internal Processes
Organizations are required to monitor customer satisfaction to determine if their quality objectives are being met
Customer satisfaction with Product Quality
Review and approval of documents for adequacy prior to release
Document Control
Centralizes all of the key elements of quality and product records and allow for more effective collaboration across dispersed teams and partners
Enterprise Quality Management Software
Develops the structure of a QMS, its processes, and plans for implementation
Design and Build
Served in a granular fashion by breaking each process down into subprocesses and education staff on documentation, education, training, tools, and metrics
Deploy
Are two areas of establishing a QMS that is largely accomplished through routine, systematic audits of the QMS
Control Measure
How the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit
Review and Improve
An internationally recognized standard that proves your company meets rigorous quality management requirements
ISO Crrtification
Defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system
ISO 9000
Requirements is the standard used for registration by demonstrating conformity of the QMS to customers, regulations, and the organization’s own requirements
ISO 9001: 2000 - Quality Management Systems
Guidelines for performance improvement provide guidelines that an organization can use to establish a QMS focused on improving performance
ISO 9004: 2000 - Quality Management systems
Its development and release represent the first attempt to unify the requirements of NASA, DOD, and FAA while satisfying the aerospace industry’s business needs
AS 9100
Entitled Quality Systems Automotive Suppliers-Particular requirements for the application of ISO 9001
ISO/ITS 16949
A specific set of requirements based on ISO 9001 that defines the design, development, production, delivery, installation, and maintenance of telecommunications products and service
TL 9000
Highlights the two basic tenets of what quality management is intended to achieve systems to ensure
Encourages businesses to implement processes and consistent product and service output while ensuring that customer satisfaction is enhanced through conformity and improvement
Scope of the Standard
Provides a better understanding of the terms used in ISO 9001:2015 through relatable comparisons to the vocabulary used in the ISO 9000:2015 standard
Normative References
References for better understanding basic terms by highlighting vocabulary and definitions from ISO 9000:2015
Terms and Definitions
Quality management - Quality of an organisation - Guidance to achieve sustained success
ISO 9004-2018
Guidelines for auditing management systems
ISO 9011-2018
Quality Management - Customer satisfaction - Guidelines for monitoring and measuring
ISO 10004-2018
The most important step in implementing a quality system
Top Management Commitment
