Best Practices for Compliance with ISO 9001 Standards

How important is ISO 9001:2015?

It’s one of the most significant updates in ISO standards. It affects almost every industry and every supplier. All companies that are certified to ISO 9001 must conform to the new standards by September 2018.

ISO 9001:2015 sets out the criteria for a quality management system and can be used in any organization. Currently, there are more than 1 million organizations in more than 170 countries certified in ISO 9001.

Will your company be certified to the new standards?

During this webcast, we will discuss how to develop compliant management system standards and best practices for implementing the provisions of the revised standards.

Key learnings:

  • Understand how the revision of ISO 9001 can impact healthcare industries
  • Develop a risk management strategy that integrates infrastructure, people, regulations and raw material
  • Understand the new requirements for defining objectives (the old way is dead) and when actions need to be taken and learn how to assign the right individual to implement those objectives
  • Implement objectives that comply with the new rules for monitoring progress on the objectives and, most importantly, the actual results
  • Revamp your program to accommodate the ground-breaking replacement of the term “preventive action” in ISO 9001:2015 with “risk management,” as detailed in Section 6.1, “Actions to address risks and opportunities”
  • Revise your program to comply with ISO 13845 requirements related to 9001

View Webcast

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Eamonn Hoxey

VP, Medical Devices Quality & Regulatory Compliance

Johnson & Johnson

Tom Middleton

Solutions Architect

Sparta Systems

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