Lifecycle Biotechnologies Receives Recertification to ISO 9001 and 13485 Standards

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Lifecycle successful received certification to the updated versions of ISO 9001:2015 and ISO 13485:2016

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Certification to the updated versions of these ISO standards will ensure Lifecycle continues to provide our customers and partners with the upmost level of quality throughout our processes and in our products

Lifecycle Biotechnologies, a leading life science tools and services supplier, has announced its successful transition to the 2015 version of ISO 9001 and the 2016 version of ISO 13485 of its Boval BioSolutions and Chata Biosystems facilities. These facilities and Lifecycle’s robust quality management system (QMS) were certified to the previous versions of these ISO standards as quality has and will continue to play a critical role in Lifecycle’s business and products.

“Certification to the updated versions of these ISO standards will ensure Lifecycle continues to provide our customers and partners with the upmost level of quality throughout our processes and in our products,” commented Michelle Stahla-Quintana, Lifecycle’s Sr. Director of Quality and Regulatory Affairs. “This successful transition not only demonstrates our commitment to supporting our customers and employees, but emphasizes Lifecycle’s core values to be relevant, be admired and to be accountable.”

ISO 9001 is the international standard that specifies requirements for a QMS. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, leadership, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:

  • Requirements for a quality management system, including documented information, planning and determining process interactions
  • Leadership and responsibilities of management
  • Management of resources, including human resources and an organization’s work environment
  • Product realization, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act). Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes under DO, clause 9 comes under CHECK and clause 10 is covered by ACT. With this new arrangement, the new ISO 9001:2015 strives to give additional momentum to the continuous and systematic improvement of processes within organizations. In addition, the 2015 version puts more emphasis on measuring and properly assessing the input and output of processes, puts risk-based thinking at the core of the QMS, includes suppliers, personnel, shareholders, legislative bodies, society, internal customers, etc. now as interested parties, in addition to customers, and places more emphasis on leadership and management commitment.

ISO 13485 is the international standard that specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The ISO 13485:2016 version was updated for two main reasons: to keep up with changes in the industry and to address changes in the underlying ISO 9001 standard. While the 2003 version expected you to establish a QMS that complies with just ISO 13485, the new one now explicitly expects one to also comply with all applicable regulatory requirements. In addition, the 2016 version includes a focus on risk-based approach, medical device files, record keeping, product realization, user training, design and development inputs, verification, validation and changes, purchasing, supplier monitoring, process validation, complaints, improvements, and so on.

Not mentioned but worth note, is that Lifecycle’s VI Plastics facility has already received certification to ISO 9001:2015.

To learn more about these certifications, Lifecycle’s QMS, and how these allow Lifecycle to better support you and secure your supply chain please contact Lifecycle Biotechnologies at info@lifecyclebio.com, 817.840.7855, or http://www.lifecyclebio.com.

Based in Ft. Worth, TX, Lifecycle Biotechnologies has served the life science industry for 40 years. Lifecycle’s products are the beginning of the lifecycle of the lifesaving and life-enhancing medical products used globally today. As a leading life sciences tools and service supplier, Lifecycle fully understands the critical role its products play in many of the world’s leading pharmaceuticals, medical devices, biologics, cell- and tissue-based products and many other medical products. While Lifecycle’s products aren’t used to diagnose, treat, or cure patients, without our contribution, none of this would be possible.

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Aaron Schieving
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