ISO 13485

What is ISO 13485 QMS

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers

Its primary objective is to facilitate harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

Implementation of a Quality Management System with several enhancements Risk Management approach to product development and product realisation Validation of processes Compliance with statutory and regulatory requirements Effective product traceability and recall systems

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and—pre-eminently—various global regulators. While being certified to 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.

13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter.

“The fact that ISO 13485 counsels the application of ISO 14971 speaks to its importance for those seeking 13485 certification,” says Mairead Ridge, marketing associate for IBS America (Lexington, MA). “Compliance programs for both standards, when implemented together, can help manufacturers build an enterprise program for risk management and quality assurance.” Evidencing the consistent assessment and mitigation of risks throughout all stages of a product’s lifecycle is important for achieving certification to both 13485 and 14971.

Benefits of iso 13485

Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements Reduced operating costs - through continual improvement of processes and resulting operational efficiencies Improved stakeholder relationships - including staff, customers and suppliers Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers Improved risk management - through greater consistency and traceability of products and use of risk management techniques Proven business credentials - through independent verification against recognized standards Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

How to achieve ISO 13485 certification - ISO 13485 implementation / Compliance / Certification steps

Lakshy Management Consultant Pvt Ltd. offers a well defined and globally proven implementation methodology for ISO 13485 certification.

Gap AnalysisAwareness TrainingProcess Identification and definitionDocumentation Design and finalizationImplementationInternal Auditor Training and conduct of internal auditManagement Review MeetingReview of ImplementationPre-assessmentStage 1 – certification auditStage 2 – certification auditAward of ISO 13485 certificationContinual improvement of the system through value added consulting and training services

What are the requirements of ISO 13485 standard ?

As mentioned, the ISO-13485 has special requirements that are not covered by ISO-9001:2008. These special requirements include both documentation and system/process requirements that cater to the medical device industry.

Aside from regulation-required documents, additional documentations required by ISO-13485 include those pertaining to: 1) responsibilities and authorities; 2) training procedures; 3) health, cleanliness, and clothing; 6) environmental conditions; 7) control of contaminated products; 8) risk management; 9) customer requirements; 10) design and development; 11) purchasing control, including purchase traceability and verification; 12) reference materials; 13) labeling and packaging; 14) installation and verification; 15) sterilization process validation; 16) preservation of product (including shelf life); and 17) measurement and monitoring.

Special system/process requirements of the ISO-13485 include: 1) risk management systems;  2) clinical evaluations and trials; 3) product cleanliness and contamination controls; 4) requirements for implantable devices; 5) proper communication of advisory notices; and 6) additional research and development requirements

Integrate ISO 13485 with other management system standards

ISO 13485 is designed to be compatible with other management systems standards and specifications, such as ISO 9001, OHSAS 18001, ISO 22000, ISO 17025, ISO 27001, ISO 14001 Environment and other ISO standards. They can be integrated seamlessly through Integrated Management system approach. They share many principles so choosing an integrated management system can offer excellent value for money and an easier approach to implement, manage and improve multiple standards simultaneously.

What we offer in the field of ISO 13485 standard and certification

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We provide unmatched expertise and technical competence to ensure that your ISO 13485 quality management system certification project adds value to your organization.

We provide consulting, training, internal audits, pre assessment audits and facilitation during ISO 13485 certification audit.

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