After over three years of revision work and nearly 95 participating and observing countries, the new ISO 9001:2015 was published on September 23, 2015.
This new approach has been released to respond to the latest market trends and will bring the quality standards into the 21st century.
What are the main changes from the previous editions?
Less prescriptive than its predecessors, ISO 9001:2015 is focused on performance. This new edition is aimed at achieving it by combining the process approach with risk-based thinking and employing the Plan-Do-Check-Act cycle at all organization levels. Some of the goals of this new version are the prevention of undesirable outcomes and the easier use of the ISO 9001 in conjunction with other management systems, with increased importance given to risk.
ISO 9001:2015 also provides a solid base for sector-quality standards, such as in the medical devicesindustry, automotive, aerospace, etc.
Risk Management as a new concept
The risk management concept is replacing the term “preventive action” which has been completely removed from this new ISO. The purpose of this change is to force organizations to have a preventive mind-set, allowing them to independently examine all the external and internal factors which can potentially impact them, and determine which ones can lead to major consequences.
What should Certified Medical Device manufacturers do?
It is essential to bear in mind that ISO 9001:2015 replaces the previous editions of the same standard.
Certified companies will have up to three years to migrate their certificates to the new version.
Taking into account the needs of regulators that are continually updated, Obelis with more than 27 years of experience in EU Regulatory affairs, is able to assist you by providing a wide range of services to ensure that medical device manufacturers comply with EU Regulations/Directives.
If you want more information on ISO 9001:2015 please do not hesitate to contact us!