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Quality Mangement
Systems
INTRODUCTION
- A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization's ability to meet customer requirements.)
- Generically referred to the group of documents as a QMS, but specifically it refers to the entire system - the documents just describe it. A QMS is nothing more than good business sense.
- ISO 9000 is an example of a Quality Management System.
ISO
9000
ISO 9000 is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.
Individuals and organizations cannot be certified to ISO 9000. ISO 9001 is the only standard within the ISO 9000 family to which organizations can certify.
ISO
9000:2000
ISO 9000:2000
ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.
The ISO 9000:2000 revision had five goals:
• Meet stakeholder needs
• Be usable by all sizes of organizations
• Be usable by all sectors
• Be simple and clearly understood
• Connect quality management system to business processes
ISO 9000:2000 was again updated in 2008 and 2015. ISO 9000:2015 is the most current version.
ELEMENTS
ELEMENTS
The ISO 9000 and ISO 9001:2015 standards are based on seven quality management principles that senior management can apply for organizational improvement:
Customer focus
1.Customer focus
• Understand the needs of existing and future customers
• Align organizational objectives with customer needs
• Meet customer requirements
• Measure customer satisfaction
• Manage customer relationships
• Aim to exceed customer expectations
Leadership
2.Leadership
• Establish a vision and direction for the organization
• Set challenging goals
• Model organizational values
• Establish trust
• Equip and empower employees
• Recognize employee contributions
Engagement of people
3. Engagement of people
• Ensure that people’s abilities are used and valued
• Make people accountable
• Enable participation in continual improvement
• Evaluate individual performance
• Enable learning and knowledge sharing
• Enable open discussion of problems and constraints
Process approach
4. Process approach
• Manage activities as processes
• Measure the capability of activities
• Identify linkages between activities
• Prioritize improvement opportunities
• Deploy resources effectively
Improvement
5.Improvement
• Improve organizational performance and capabilities
• Align improvement activities
• Empower people to make improvements
• Measure improvement consistently
• Celebrate improvements
Decision making
6. Evidence-based decision making
• Ensure the accessibility of accurate and reliable data
• Use appropriate methods to analyze data
• Make decisions based on analysis
• Balance data analysis with practical experience
Relationship management
7. Relationship management
• Identify and select suppliers to manage costs, optimize resources, and create value
• Establish relationships considering both the short and long term
• Share expertise, resources, information, and plans with partners
• Collaborate on improvement and development activities
• Recognize supplier successes
Implementation Steps:
IMPLEMENTATION
STEP 1: COMMITMENT FROM TOP MANAGEMENT
STEP 2: ESTABLISHING AN IMPLEMENTATION TEAM
STEP 3: CONDUCTING ISO 9000 AWARENESS PROGRAMS
STEP 4: PROVIDING TRAINING
STEP 5: CONDUCTING AN INITIAL STATUS SURVEY
STEP 6: CREATING A DOCUMENTED IMPLEMENTATION PLAN
STEP 7: DEVELOPING A QMS DOCUMENTATION
STEP 8: CONTROL OF DOCUMENTS
STEP 9: IMPLEMENTATION
STEP 10: INTERNAL QUALITY AUDIT
STEP 11: REVIEWING BY MANAGEMENT
STEP 12: PRE-ASSESSMENT AUDIT
STEP 13: CERTIFICATION AND REGISTRATION
STEP 14: CONTINUAL IMPROVEMENT
Documentation:-
Documentation
1. Quality Manual
2. Control of Documents
3. Control of Records
4. Internal Audit
5. Control of Non-Conforming Products
6. Corrective Actions
7. Preventive Actions
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team.