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What is ISO 9001?

  • ISO 9001 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction.
  • A new version of the standard, ISO 9001:2015, has just been launched, replacing the previous version (ISO 9001:2008).

 

What is a Quality Management System (QMS)?

  • A quality management system is a way of defining how an organization can meet the requirements of its customers and other stakeholders affected by its work.
  • ISO 9001 is based on the idea of continual improvement.
  • It doesn’t specify what the objectives relating to “quality” or “meeting customer needs” should be, but requires organizations to define these objectives themselves and continually improve their processes in order to reach them.

Rationale

  • Executive Order 605 mandates all government agencies and instrumentalities including GFIs, GOCCs, and LGUs to institutionalize Quality Management System using ISO 9001:2015 standards.

Objective

  • Ensure that the hospital QMS is in accordance with ISO 9001:2015 standards
  • Determine that the ISO 9001:2015 standards were already immersed in the hospital system
  • Continually improve the hospital QMS

Requirements

  • Approach – the ISO certifying body must conduct on-site audit of hospital QMS and all documented procedures and processes including implementation using ISO 9001:2015 standards.

(Scope: Provision of Level 3 Hospital Services and Public Health Unit Services including Training and Research)

  • In the event that a re-audit is necessary due to any major non-conformities based on the standards, the client shall pay a corresponding charge for the re-audit of the conformity in question until the conformity to the standards is achieved.

The Journey

ISO Cert 2

 

ISO Certifications

ISOCert2014 16

ISO 9001:2008

Scope: Hospital and other Health Related Services

Year: 2014-2016

 

ISOCert2017

ISO 9001:2015

Scope: Provision of Level 3 Hospital Services and

Public Health Unit Services (excluding Residency Training Program)

Year: 2017

ISOCert2019

 

ISO 9001:2015

Scope: Provision of Level 3 Hospital Services and

Public Health Unit Services Including Training and Research

Year: 2019

 

ISOCert2020

 

ISO 9001:2015

Scope: Provision of Level 3 Hospital Services and

Public Health Unit Services Including Training and Research

Year: 2020