ISO 9001:2015 Registration & Certification

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What Is ISO 9001?

"ISO 9001 Certified" means an organization has met the requirements in ISO 9001. It defines an ISO 9000 Quality Management System (QMS) and is focused on meeting customer expectations and delivering customer satisfaction.

What Does ISO 9001 Specify?

ISO 9001:2015 specifies criteria for a quality management system and is the only standard in the family that can be certified.

To qualify, an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

This standard is based on a number of Quality Management Principles, including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.

Why Is ISO 9001 Certification Important?

The ISO 9000 family of QMS standards is designed to help organizations ensure they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or program.

Following the standard helps manufacturers achieve consistent results and continually improve their processes

Like ISO 13485, A Quality Management System (QMS) Provides

  • Improved Product Safety
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management
  • Increased Consistency in Meeting (or Exceeding) Customer Requirements