Chapter 11: ISO 9000 Quality Management System

ISO 9000

-deals with management systems to ensure quality in design, production, delivery, and support products

Different standards that led to improve quality and safety for different sectors:

-ISO 9000 (Wide Range of Industry/Economic Sectors and Regulatory Areas) -ISO 9001-2015 (Important Change in Quality Management System) -ISO 14000 (Standard for Environment Management System) -cGMP (Current Good Manufacturing Practices) -AS9100 (Standard Quality Management System for the Aerospace Industry)

Quality Management

-achieving results that satisfy the requirements for quality -motivated by stakeholders internal to the organization, especially the organization's management -goal is to satisfy all stakeholders -effective, efficient, and continually improving overall quality-related performance is the intended result -scope covers all activities that affect the total quality-related business results of the organization

Need to revise from 2008 to 2015?

-all ISO management system standards are subject to a regular review under the rules by which they are written -ISO standards are reviewed every 5 YEARS and revised if needed -the challenges faced by businesses and organizations today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account

Quality Assurance

-demonstrating that the requirements for quality have been achieved -motivated by stakeholders, especially customers, external to the organization -goal is to satisfy all customers -confidence in the organization's products is intended result -scope of demonstration covers activities that directly affect quality-related process and product results

Quality System Certification/Registration

-earliest users of quality assurance requirements standards were large customer organizations such as electric power providers and military organizations -Quality assurance requirements are called up in a two party contract 1. Providing organization supplier - first party 2. Customer organization - second party -INTERNAL AUDIT sponsored by the providing organization to verify that it's quality system meets the contract requirements (these are first party audits) -EXTERNAL AUDIT sponsored by the customer organization to verify that the supplier organization's quality system meets the contract requirements (these are the second party audits) -INTERNAL AND EXTERNAL AUDITS have become burdensome because the audits became redundant as each organization is audited multiple times for the same requirement resulting to additional costs for both parties -to reduce the redundancy of audits, the development of quality system certification -a third-party organization called a "certification body"/registrar conducts a formal audit of a supplier organization to assess conformance to the appropriate quality system standard (ISO 9001/2) (issues a certificate and registers the organization's quality system) -to maintain the registered status, the organization must pass periodic surveillance audits

Organization Performance Excellence Systems

-include planning, control, and improvement methods and applied to all processes in an enterprise -focused on effectiveness and efficiency

ISO 9000 Quality Management System Standard Family

-is a family of standards for a Quality Management System (ISO 9000, 9001, 9002, 9003, 9004) -ISO 9000 contains fundamental concepts and road map guideline standard 9000 -ISO 9001/2/3 are the three alternative requirements standards for quality assurance -ISO 9004 contains the Quality Management Guideline Standard

Quality Management System (QMS)

-is a set of policies, processes and procedures required for planning and execution in the core business area of organization -good business practices

International Organization fornStandardization (ISO)

-is an independent, non-governmental, and international standard setting body composed of representatives from various national organizations (1 member per country) founded in 1947 -promotes proprietary, industrial, and commercial standards -set of international standards for assessing a company's performance

ISO 9001

-is an internationally recognized QMS standard which acts as a quality benchmark when evaluating organizations -the main objective is to ensure customer satisfaction -is industry generic in which anyone can use -can be used by both manufacturing and service industries -only tells WHAT TO DO, not how to do it - is NOT a product standard meaning it doesn't contain product requirements

ISO 9001 Certification

-means that you have a QMS in place to control your processes and deliver consistent results designed to meet the customers' requirements

ISO 9001 Standard is based on PDCA Concept

1. Plan -Clauses 4, 5, 6, 7 2. Do -Clause 8 3. Check -Clause 9 4. Act -Clause 10

Steps to ISO 9001 Certification

Implementation plan should cover these items: 1. Learn and understand ISO 9001 -review ISO 9001 Standard and supporting materials 2. Project a Gap Analysis -evaluate current quality system vs ISO 9001 3. Plan project and allocate resources -people, money, time 4. Training the Organization -management representative, project team, employees 5. Create and Document a QMS -adding/revising processes 6. Use and Improve QMS 7. Internal Audit for QMS to ensure that objectives are met -corrective action is taken in addressing errors 8. Certification Audit of your QMS (3-year Certification) -Year 1 = Certification Audit -Years 2 & 3 = Surveillance Audits -execute normal organizational activities following the QMS

Major Requirement Clauses of ISO 9001

Management Responsibility -commitment, customer focus, policy, planning, responsibility, authority and communication, review Resource Management -HR, infrastructure, work environment Product Realization -customer requirements, design, purchasing, operations, calibration Measurement and Analysis -customer satisfaction, audit, process/product control, non-conforming product, data analysis, improvement

ISO 9001:2008

TERMINOLOGIES: -products -exclusions -documentation, quality manual, documented procedures, records, instructions -work environment -monitoring and measuring equipment -purchased product -supplier PRINCIPLES: -customer focus -involvement of people -process approach -system approach to management -continual improvement -factual approach to decision making -mutual beneficial supplier relationship CLAUSES: 0. Introduction 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement

ISO 9001:2015

TERMINOLOGIES: -products and services -exclusions are NOT used -documented information -environment for the operation of the processes -monitoring and measuring equipment - externally provided products and services -external provider PRINCIPLES: -customer focus -engagement of people -process approach -leadership -improvement -evidence-based decision making -relationship management CLAUSES: 0. Introduction 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement

Core Areas

are areas that can impact the organization's ability to meet stakeholders' requirements: -quotations, purchasing, production, shipping -quality: must correct errors to achieve consistent results