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Introduction to quality and iso 9001

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MANAGEMENT SYSTEM

Set of interrelated elements of an organization or that interact to establish policies, objectives and processes to achieve these objectives.

For example:

Quality Management System (QMS): Manage quality

Financial Management System (SGF).

MANAGEMENT PRINCIPLES

Terms related to Quality management

introduction-quality-iso-9001-2008

Quality: Customer satisfaction (degree to which customer expectations have been met).

Degree to which a set of inherent characteristics of an object meets the requirements.

Customers: person or organization that could receive or receives a product or service intended for or required by it.

Stakeholders: Person or organization that can affect or be perceived as affected by a decision or activity (competitors or lobbyists with opposing interests) Q.

Process Approach: Result approach.

* Based on the ISO-9000: 2015 standard

MANAGEMENT PRINCIPLES

The 8 Principles of Quality Management

1) Customer focus

2) Leadership

3) Staff involvement

4) Process-based approach (results)

5) System approach to management

6) Continual improvement

7) Fact-based approach (evidence) for decision making

8) Mutually beneficial relationships with the supplier

* Based on the ISO-9001: 2008 standard

LET'S EXPLAIN A LITTLE THE APPROACH TO PROCESSES

… mutually related or interacting… transform input elements into results ”

LET'S EXPLAIN A LITTLE THE PROCESS APPROACH

Let's talk about the Standard! ISO-9001: 2008

Standard What is ISO ?:

It is the International Organization for Standardization in charge of producing and promoting the development of international standards.

Examples:

ISO: 9001, ISO: 14000, ISO: 22000

ISO 9001 is an international standard that establishes the requirements that the operations of a company must meet to form an

effective Quality Management System

REPORT BY MANAGEMENT (RXD)

Management responsibility

Top management must establish a commitment to the Quality Management System.

In order to increase customer satisfaction: Quality Policy

Audits

They are defined as a systematic, independent and documented process for obtaining and evaluating evidence.

Compliance: meets the requirements defined for it.

Non-Conformity: Non-compliance with legal or regulatory requirements, established in a NORM, established by the organization, by the client or interested party.

TYPES OF NON-CONFORMITY (NC)

Major Non-Conformity:

1- Total failure of any critical work procedure or instruction.

2- Absence of any procedure required by the Standard.

3- Several minor failures of some procedure.

4- Risk that threatens the quality of the system.

Minor Nonconformity:

1- Deficiency in a procedure or work instruction.

2- Minor deficiencies in the Quality System, but that do not justify a Major NC.

Grant / Diversion Permission: Authorization to use or release a product that does not conform to specified requirements.

Non-conformities are also known as SAC: Corrective Action Request.

Corrective Actions and Improvement Plans

Corrective Action:

Action taken to eliminate the causes of a non-conformity, defect or any existing undesirable situation, to avoid its repetition.

Preventive Action:

Action taken to eliminate the causes of a non-conformity, defect or any potential undesirable situation, in order to prevent it from occurring.

WHAT IS AN INDICATOR?

Indicators or KPIs:

Set of data that helps to objectively measure the EVOLUTION of a process to determine if it is meeting the established objectives.

It is not the objective of the indicators to measure people, but rather processes.

Important.

Do not confuse indicators with objectives

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Introduction to quality and iso 9001