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ISO 9001:2015
QUALITY MANGEMENT SYSTEM
SANGAMESH R KADAGI
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION
• ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use
the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
• ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the
national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
• ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than
160 countries have applied the ISO 9001 standard requirements to their quality management systems.
Organizations of all types and sizes find that using the ISO 9001 standard helps them:
 Organize processes
 Improve the efficiency of processes
 Continually improve
ISO 9001:2015 INCLUDE:
SPECIFIC SECTIONS OF THE STANDARD CONTAIN
INFORMATION ON MANY TOPICS, SUCH AS:
 Requirements for a QMS, including documented information, planning and determining process interactions
 Responsibilities of management
 Management of resources, including human resources and an organization’s work environment
 Product realization, including the steps from design to delivery
• Measurement, analysis, and improvement of the QMS through activities like internal audits
BENEFITS OF ISO 9001
• ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in
turn brings many benefits, including satisfied customers, management, and employees.
using the standard helps them:
 Organize a QMS
 Create satisfied customers, management, and employees
 Continually improve their processes
 Save costs
THESE BENEFITS OFFER ADDITIONAL ADVANTAGES, LIKE:
 Defining, improving, and controlling processes
 Reducing waste
 Preventing mistakes
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction
 Communicating a readiness to produce consistent results
HOW TO GET ISO 9001 CERTIFIED:
 Build and implement a quality management system in accordance with the principles of the latest ISO 9001 standard
 Have an audit performed by a Certified Body (CB or Registrar) to assess the performance of your QMS against the latest
ISO 9001 standard.
 If you are successful, the certificate will need to be recertified after three years (and every subsequent three years) to
make sure you’re still up to standard (as well as any new changes to the standard)
ISO 9001 MANDATORY REQUIREMENTS
• Monitoring and measuring equipment calibration records
 Records of training, skills, experience and qualifications
 Product/service requirements review records
 Record about design and development outputs review
 Record about design and development inputs
 Records of design and development controls
 Records of design and development outputs
 Design and development changes records
 Characteristics of product to be produced and service to be
provided
 Records about customer property
 Production/service provision change control records
 Record of conformity of product/service with acceptance criteria
 Record of nonconforming outputs
 Monitoring measurement results
 Internal audit program
 Results of internal audits
 Results of the management review
 Results of corrective actions
THANK YOU

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Iso 9001 Quality management system

  • 1. ISO 9001:2015 QUALITY MANGEMENT SYSTEM SANGAMESH R KADAGI
  • 2. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. • ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015. • ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them:  Organize processes  Improve the efficiency of processes  Continually improve
  • 4. SPECIFIC SECTIONS OF THE STANDARD CONTAIN INFORMATION ON MANY TOPICS, SUCH AS:  Requirements for a QMS, including documented information, planning and determining process interactions  Responsibilities of management  Management of resources, including human resources and an organization’s work environment  Product realization, including the steps from design to delivery • Measurement, analysis, and improvement of the QMS through activities like internal audits
  • 5. BENEFITS OF ISO 9001 • ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees. using the standard helps them:  Organize a QMS  Create satisfied customers, management, and employees  Continually improve their processes  Save costs
  • 6. THESE BENEFITS OFFER ADDITIONAL ADVANTAGES, LIKE:  Defining, improving, and controlling processes  Reducing waste  Preventing mistakes  Lowering costs  Facilitating and identifying training opportunities  Engaging staff  Setting organization-wide direction  Communicating a readiness to produce consistent results
  • 7. HOW TO GET ISO 9001 CERTIFIED:  Build and implement a quality management system in accordance with the principles of the latest ISO 9001 standard  Have an audit performed by a Certified Body (CB or Registrar) to assess the performance of your QMS against the latest ISO 9001 standard.  If you are successful, the certificate will need to be recertified after three years (and every subsequent three years) to make sure you’re still up to standard (as well as any new changes to the standard)
  • 8. ISO 9001 MANDATORY REQUIREMENTS • Monitoring and measuring equipment calibration records  Records of training, skills, experience and qualifications  Product/service requirements review records  Record about design and development outputs review  Record about design and development inputs  Records of design and development controls  Records of design and development outputs  Design and development changes records  Characteristics of product to be produced and service to be provided  Records about customer property  Production/service provision change control records  Record of conformity of product/service with acceptance criteria  Record of nonconforming outputs  Monitoring measurement results  Internal audit program  Results of internal audits  Results of the management review  Results of corrective actions