ISO 9001 Workshop: Implementation Guide

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Questions and Answers

According to Joseph Juran, what is quality?

“Qualidade é adequação ao uso.” (Quality is fitness for use)

According to Philip Crosby, what comprises quality?

“Conformidade com as especificações.” (Conformity with specifications)

According to Kaoru Ishikawa, what is quality?

“Qualidade é satisfazer o cliente, interno ou externo, atendendo ou excedendo suas expectativas, através da melhoria contínua do processo.” (Quality is to satisfy the customer, internal or external, meeting or exceeding their expectations, through continuous improvement of the process.)

According to NBR ISO 9000:2015, what promotes a culture that results in behaviors, attitudes, activities and processes?

<p>Uma organização focada em qualidade (An organization focused on quality)</p> Signup and view all the answers

What is determined by the ability to satisfy customers and by the intended and unintended impact on relevant interested parties?

<p>A qualidade dos produtos e serviços de uma organização (The quality of the products and services of an organization)</p> Signup and view all the answers

According to NBR ISO 9000:2015, what is the definition of quality?

<p>Grau em que um conjunto de características inerentes de um objeto satisfaz requisitos (Degree to which a set of inherent characteristics of an object satisfies requirements)</p> Signup and view all the answers

What is the definition of an external client?

<p>Cliente externo é a pessoa ou entidade que compra produtos ou serviços da empresa, estando fora da nossa estrutura organizacional. (An external customer is the person or entity that purchases products or services from the company, being outside of our organizational structure.)</p> Signup and view all the answers

What is a process?

<p>Um conjunto de ações que visam atingir um objetivo (A set of actions that aim to achieve an objective)</p> Signup and view all the answers

What is a Quality Management System (QMS)?

<p>Um Sistema de Gestão da Qualidade (SGQ) é um conjunto de políticas, processos e procedimentos documentados que ajudam uma organização a planejar, implementar, monitorar e melhorar continuamente a qualidade de seus produtos, serviços ou processos. (A Quality Management System (QMS) is a set of documented policies, processes and procedures that help an organization to plan, implement, monitor and continuously improve the quality of its products, services or processes.)</p> Signup and view all the answers

What is ISO 9001?

<p>Uma norma internacional que estabelece os requisitos para a implementação de um Sistema de Gestão da Qualidade (SGQ). (An international standard that establishes the requirements for the implementation of a Quality Management System (QMS).)</p> Signup and view all the answers

What is an audit?

<p>Um processo de análise sistemática e criteriosa da documentação de uma empresa. (A process of systematic and careful analysis of a company's documentation.)</p> Signup and view all the answers

What is an internal audit?

<p>Um processo realizado pela própria organização para avaliar a conformidade do Sistema de Gestão da Qualidade com a norma ISO 9001. (A process carried out by the organization itself to assess the conformity of the Quality Management System with the ISO 9001 standard.)</p> Signup and view all the answers

What are the benefits of ISO 9001 certification?

<p>Melhoria da Eficiência, Aumento da Satisfação do Cliente, Redução de Riscos, Fortalecimento da Imagem (Improved Efficiency, Increased Customer Satisfaction, Reduced Risks, Enhanced Image)</p> Signup and view all the answers

What are the initial steps for planning a quality management system?

<p>Definição do Escopo, Política da Qualidade, Objetivos da Qualidade (Scope Definition, Quality Policy, Quality Objectives)</p> Signup and view all the answers

What are the next steps and final considerations for implementing ISO 9001?

<p>Seguir o cronograma e metas para a implementação da ISO 9001, Realizar auditorias internas para avaliar a conformidade com os requisitos, Solicitar a certificação de um organismo independente após a implementação. (Follow the schedule and goals for the implementation of ISO 9001, Conduct internal audits to assess compliance with requirements, Request certification from an independent body after implementation.)</p> Signup and view all the answers

Flashcards

Kaoru Ishikawa's definition of quality?

Satisfying the client, internally or externally, is done by meeting or exceeding expectations through continual improvement.

Quality Definition (ISO 9000:2015)

The degree to which a set of inherent characteristics of an object fulfills requirements per NBR ISO 9000:2015.

External Client

A person or entity that buys products or services from a company, external to its organizational structure.

Internal Client

The people and processes within a company.

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What is a process?

A set of actions aimed at achieving an objective, adding value through input to output.

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Quality Management System (QMS)

A set of documented policies, processes, and procedures that help an organization plan, implement, monitor, and improve the quality of its products, services, or processes.

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What is ISO 9001?

An international standard that sets requirements for a Quality Management System (QMS).

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What is an Audit?

A systematic and critical analysis of a company's documentation to verify that activities and processes conform to specified requirements and are effective.

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Internal Audit

A process conducted by the organization itself to evaluate conformance to the ISO 9001 standard.

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External Audit

An independent evaluation by a certified body to verify an organization's compliance with ISO 9001 requirements.

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Improved Efficiency (ISO 9001)

ISO 9001 helps streamline operations, reducing waste and increasing productivity.

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Increased Customer Satisfaction (ISO 9001)

ISO 9001 promotes consistency in product and service quality, ensuring customer satisfaction.

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Reduced Risks (ISO 9001)

ISO 9001 minimizes errors, failures, and costs related to quality issues.

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Enhanced Reputation (ISO 9001)

ISO 9001 demonstrates a commitment to quality which can enhance the organization's reputation.

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Scope Definition

The first step when planning your quality management system is defining the scope.

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Policy Definition

The second step when planning your quality management system is defining the policy.

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Setting Objectives

The last step when planning your quality management system is setting objectives

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Study Notes

  • Workshop about the implementation of ISO 9001
  • This workshop covers the benefits, crucial steps, and requirements for ISO 9001 implementation

Defining Quality

  • Joseph Juran defined it as "fitness for use."
  • Philip Crosby defined it as "conformance to specifications."
  • Kaoru Ishikawa defined it as customer satisfaction, both internal and external, by meeting or exceeding expectations through continuous improvement

ISO 9000:2015 Definition

  • Quality is defined as the degree to which a set of inherent characteristics fulfills requirements
  • A quality-focused organization fosters a culture that adds value by meeting the needs and expectations of customers and relevant stakeholders

Customers

  • External customers are entities that purchase products or services from the company but are outside its organizational structure
  • Internal customers are the people and processes related to the company

Processes

  • Processes consist of actions aimed at achieving an objective
  • Processes involve input, processing, and output, adding value throughout

Quality Management System (QMS)

  • A QMS includes documented policies, processes, and procedures that help an organization plan, implement, monitor, and continuously improve its products, services, or processes

About ISO 9001

  • ISO 9001 is an international standard defining the requirements for implementing a Quality Management System (QMS)
  • It is published by the International Organization for Standardization (ISO)
  • It is a reference for ensuring organizations consistently deliver quality products and services

Audits

  • Audits involve systematically analyzing the documentation of a company for compliance, effectiveness, and adherence to specifications

Audit types

  • Internal audits is conducted internally to assess compliance with ISO 9001, identifying areas for improvement
  • External audits is conducted independently by an accredited organization to verify compliance with ISO 9001, focusing on the QMS

Benefits of ISO 9001 certification

  • Enhanced efficiency for optimizing processes, reducing waste, and increasing productivity
  • Better customer satisfaction as the norm ensures consistency in product/service quality
  • Reduced risks by minimizing errors, failures, and quality-related costs
  • Strengthened image due to certification demonstrating a commitment to quality and improving organizational reputation

ISO Implementation focus

  • Shifting from reactive quality control to proactive quality assurance with focus of preventing faults
  • Quality and Customer Satisfaction goals includes increasing customer satisfaction by 70% and reducing errors/problems annually
  • Commitment to training employees for skill improvement and expanding market participation

System Planning

  • System planning includes defining the scope, outlining a quality policy, and setting objectives
  • Policies should declaring quality and principles for the orgaization
  • Objectives should be measureable and for all business units

Implementation steps for ISO 9001

  • Follow deadlines and goals for ISO 9001 implementation
  • Conduct internal audits to assess compliance with requirements
  • Apply for certification from an independent organization after implementation

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