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ISO 9001:2015 + ISO 13485:2016 – What’s New?

For many years MPE has held ISO 9001 certification and, more recently, ISO 13485 certification. Every couple of years the standards are reviewed and revised to adapt with the ever-changing global requirements and business needs. In April, MPE was re-certified to new versions of the ISO standards: ISO 9001:2015, which replaced the previous ISO 9001:2008, and ISO 13485:2016, which replaced ISO 13485:2003.

International Organization for Standardization (ISO) is an independent, non-governmental international organization of 161 national standard bodies. ISO develops international standards that organizations and businesses use to provide products, services and systems while ensuring quality, safety and efficiency.

ISO 9001:2015 + ISO 13485:2016 - Whats New

WHY STANDARDS MATTER

Adhering to standards demonstrates the ability to consistently provide products and services that meet customer requirements and regulatory requirements. Additionally, standards aid in organizing processes, improving efficiency of processes, and provides focus on continuous improvement – thereby, improving customer satisfaction.

ISO 9001 is the global standard that specifies requirements for a quality management system (QMS) while ISO 13485 is the global standard for medical device quality management system (QMS).

With MPE’s involvement in product realization and the overarching product’s lifecycle, which includes product design and development, production, storage, transport and so forth, it is crucial for our organization uphold and demonstrate these standards.

NEW IN ISO 9001 + ISO 13485

A greater emphasis on risk-based thinking is applied to the new revision of ISO 9001 and ISO 13485. Individually, the most impactful to the new revision of ISO 9001 is the restructure of the standard. The new revision of ISO 13485 places prominence on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements.

THE MAIN CHANGES IN ISO 9001:2015

  • New terminology
  • Restructuring some of the information to the High-Level Structure that other ISO management system standards follow. (Provides ease to organizations using multiple management systems).
  • An emphasis on risk-based thinking to enhance the application of the process approach
  • Fewer prescribed requirements
  • Less emphasis on documents
  • Improved applicability for services
  • A requirement to define the boundaries of the QMS
  • Addresses supply chain management more effectively
  • Greater emphasis on achieving desired outcomes to improve customer satisfaction

THE MAIN CHANGES TO ISO 13485:2016

  • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements.
  • Increased linkage with regulatory requirements, particularly for regulatory documentation.
  • Application to organizations throughout the lifecycle and supply chain for medical devices.
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard.
  • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties.
  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records.
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance.
  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay.

MPE prides itself on our services, solutions and our Quality Management System and has established sustainable procedures which provides benefits to our OEM partners and the confidence within the products that we deliver.

“Because ‘International Organization for Standardization’ would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), our founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever the country, whatever the language, we are always ISO.”

ISO.org

Related: UDI Compliance – Is Your Company Ready?

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