ISO 9001 Requirements

ISO 9001: 2008 is the standard’s fourth revision and replaces ISO 9001:2000. The revision year follows the ISO standard code.

ISO 9001 standard was developed based on eight quality management principles to ensure company product or services consistently meet customer and applicable regulatory requirements continually improve to enhance customer satisfaction.

Standards Malaysia has adopted the ISO 9001:2008 standard, published as MS ISO 9001:2008 in 2009. You can get this standard for the price of RM50.

ISO 9001:2008 standard clauses can be briefly explain as

 

  • 4.0 Quality Management System: general requirements, documentation requirements, quality manual, control of documents and records.
  • 5.0 Management Responsibility: policy, objectives, planning, customer focus, QMS, management review.
  • 6.0 Resource Management: human resources, facilities, work environment.
  • Product Realization: contract, design, purchasing, production, calibration.
  • 8.0 Measurement, Analysis, and Improvement: customer satisfaction, audit, process/ product monitoring, control of nonconforming product, analysis of data, continual improvement, corrective and preventive action.

 

By 15 September 2018, ISO 9001:2015 will replacing ISO 9001:2008 to ensure it continues remain relevant to business challenges in enhancing customer satisfaction. What’s new in ISO 9001:2015? It’s get more involvement on leadership management and wider the QMS boundary to include organization risk and opportunities. With the new common structure of management system, its help organisation in managing multiple management systems. And the 2015 version also more user-friendly due to the simplified language for all types of organization.

 

For companies that wish to maintain your ISO 9001 certification, you need to review the existing QMS and to include all the new 2015 version requirements before 15 September 2018. Contact us for help to smooth your transition process now.

ISO 9001:2015 standard new clauses as below.

 

  • 4.0 Context of Organization: understand organization context, needs and expectation of interested parties, determine QMS scope and its processes .
  • 5.0 Leadership: leadership commitment, quality policy, roles, responsibilities and authorities.
  • 6.0 Planning: action to address risk and opportunities, quality objectives, planning of changes.
  • 7.0 Support: resources (people, infrastructure, environment for the operations of processes, monitoring and measurement, organizational knowledge.
  • 8.0 Operation: operation planning and control, requirements for products/services, design and development of product/ services, control of externally provider processes, product/services, production/service provision, release of product/service, control of nonconforming outputs
  • 9.0 Performance Evaluation: monitoring, measurement, analysis and evaluation of customer satisfaction, internal audit, management review
  • 10.0 Improvement: nonconformity and corrective action, continual improvement

 

Call us/ WhatsApp @ 019-374 6837 to learn more on ISO 9001 certification or transition assistance.