Quality Management System

Quality Management System

Definition: A Quality Management System is a collection of policies, procedures, plans, resources, processes, practices, and the specification of responsibilities and authority of an organization designed to achieve product and service quality levels, customer satisfaction, and company objectives.

Documentation:

• Quality Policy – describes the organization’s approach to quality
• Quality Manual – Addresses each principle of the ISO 9000 Standard

Documentation –
Principles of the ISO 9000 Standard:

• Customer Focus – understand needs, meet requirements, exceed expectations
• Leadership – unity of purpose, organizational direction, empowerment, achieve objectives
• Involvement of People – fully involved employees, to benefit the organization
• Process Approach – accomplishments by processes, resources must be managed
• System Approach to Management- processes are managed as a system
• Continual Improvement – permanently applied to the organization, its people, their processes, their systems, and their products
• Factual Approach to Decision Making – decisions based on analysis of accurate, relevant, and reliable data
• Mutually Beneficial Supplier relationships – organization and suppliers benefit from each other’s resources and knowledge
• Organizational Chart -Illustrates management responsibility for operating the quality system
• Quality Procedures – may be referenced in this manual
• Quality Objectives

• Goals related to quality – must be in sync with the Quality Policy
• Assigned to organizational functions
• Tracked by Top Management

• Quality Procedures

• Step by step what the company does to meet policy
• A procedure for each ISO principle
• Processes for procedures that affect the quality

• Forms. Records etc.

• Proof of activities
• Documentation for auditors
• Ensure consistency of the firm operations
• Verify conformance to standards

ISO 9000 – International Standard

• A family of standards and guidelines, that sets the requirements, for the assurance of quality and management’s involvement in an organization.  To ensure products and services are consistent with their intended purpose.
• Achieve customer satisfaction
• Continual improvement of performance and competitiveness
• Continual improvement of processes, products, and services
• Comply with regulatory requirements

How ISO 9000 is applied

• Not required by the government, up to management to follow
• May require suppliers to be compliant with standards

• Apply QMS to the operation
• Continually assess the effectiveness
• Make changes for improvement
• Conduct audits
• Submit to third party audits
• Submit to a new registration every 3 years

Authority of registration

• Awarded by a registrar or certification bodies
• Accredited by accreditations bodies
• International Accreditation Forum (IAF)
• IAF takes authority from  Article 6 of the WTO’s 1994 Agreement on Technical Barriers to Trade

Organizational Registration

• More credibility in the world marketplace
• Conforming organizational steps

• Develop a quality manual that gives assurance of quality products and services
• Document procedures of how everything will be operated
• Secure top management’s commitment to the QMS and continual improvement
• Customer requirements determined and met
• If registering they must hire an accredited registrar
• Conduct its own internal audits
• External audits from an accredited registrar

Organizational Benefits

• Provides confidence to the customer and the organization that it can provide products and services consistently
• Cost risk-management
• Improved competitiveness

Customer Benefits

• Meet requirements
• Competitive prices
• Increased confidence in products

Expectation of quality

Origin of ISO 9000:

• ISO the worldwide federation developed to harmonize national and international standards
• Developed by American National Standards Institute (ANSI) and American Society for Quality (ASQ) in 1987 after 35 years

Comparative Scope of ISO 9000 and Total Quality Management:

• ISO 9000 and TQM are not interchangeable
• ISO 9000 is compatible with and is viewed as a subset of TQM
• ISO 9000 can be implemented in a non-TQM environment
• ISO 9000 can improve operations of the traditional environment
• ISO 9000 may be redundant in a mature TQM system
• ISO 9000 and TQM are not in competition

Management Motivation for Registration to ISO 9000:

1. Merely to obtain marketing advantage – inappropriate
2. Appropriate for adopting ISO 9000

• To improve operations by implementing a QMS
• To create/improve a QMS that is recognized by the customers
• To improve product and service quality and consistency
• To improve customer satisfaction
• To improve competitive posture
• To conform to major customer requirements

ISO and Total Quality Management Working Together:

• TQM requires everything required by ISO 9000 registration
• No international certification for TQM but may seek ISO 9000 certification to meet customer demands
• ISO 9001 registration can be a good first step to TQM
• A organization that has documented processes and is involved in total quality management should find it easy to prepare for ISO 9000 certification
• Likewise an organization registered under ISO 9001 will have a head start in implementing total quality

The ISO 9000 effort will benefit from the total quality preparation phase by having the following components:

• Executive-level steering committee
• A vision of guiding principles
• A set of broad objectives
• Baselines on employee and customer satisfaction
• An objective view of the organizations strengths and weaknesses
• A good account of all employees at all levels of the organization
• Well thought out means of communicating with employees and stakeholders

A brief summary is:

• ISO 9000 and TQM are not fully interchangeable
• ISO 9000 is compatible and can be a subset of TQM
• Vastly different origins

1. ISO 9000 was developed to harmonize national and international standards
2. Total Quality came from Japan as a way for them to compete in the international marketplace

• The aim of ISO 9000 is to enable organizations to better serve their customers and be more competitive in the marketplace by adhering to quality management principles
• Motivations for implementing ISO 9000

1. To improve operations
2. To improve/create a quality management system
3. To improve the consistency of quality
4. To improve customer satisfaction
5. To improve competitive posture
6. To conform to customer requirements

• Track Nonconformances and CAPAs
• Centralize Audit Management
• Access Inspection History
• Gain Supply Chain Visibility
• Automate Management of Change
• Manage Customer Complaints
• Failure Modes and Effects Analysis (FMEA)
• Streamline Document Control
• Track Equipment Lifecycle
• Track and Enforce Training
• Improve New Product Introductions
• Automate SPC
• Better Business Decisions

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