ISO 9001

ISO 9001 Quality Management System certification as a tool for continuous improvement

ISO 9001 is the most famous international standard for Quality Management, which establishes the requirements for the implementation of a Quality Management System within an organization of any size and sector of activity.

Moreover, ISO 9001 is also the standard used as basis to be implemented with specific industry standards, including ISO 13485 specific for medical devices.

What benefits does ISO 9001 certification provide?

  • Increased customer satisfaction, thanks to a careful analysis of the context and customer needs and expectation;
  • Measurement and monitoring of company performances through specific reference parameters, allowing continuous improvement and the achievement of defined objectives;
  • Maximization of organizational and productive efficiency, optimization of business processes, with consequent reduction of waste, cost control and increase in productivity;
  • Increased competitiveness and business opportunities, through an offer of products and services that meet internationally recognized quality standards.

EN ISO 9001:2015, the new edition of the standard

In 2015 the ISO 9001 standard was significantly revised in order to update its contents to meet the needs of contemporary, highly technological and globalized world economic scenario.

The current standard ISO 9001:2015, which has definitively replaced the previous ISO 9001:2008 after a transition period of 3 years, has introduced some important new features among which:

  • Introduction of the High Structure Level (HLS) as a shared model for all management systems, for a better integration;
  • Gestione del Risk Management Approach as a systematic practice to improve customer satisfaction and ensure high performance;
  • Increased engagement and accountability through a widespread Leadership to achieve common strategic business objectives.

Why should you turn to ECM to obtain ISO 9001 certification for your company?

ECM, as an accredited body authorized to issue the certification of Quality Management Systems in accordance with EN ISO 9001:2015, uses highly qualified personnel with proven experience in the sector to carry out the certification process

necessary to assess the compliance of the company’s organizational system with the reference standard.

Our trusted team will perform the third party audit, which includes document review and on-site audit, to verify the implementation and application by the Company of the ISO 9001 requirements. Once these assessments are positive and no non-conformities are found, certification will be issued.

During the three years of validity of the certificate, ECM will carry out periodic surveillance visits on an annual basis to verify compliance over time.

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