Knowledge Axis
Background
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.
Reason for use
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
Other specific differences include:
The Promotion And Awareness Of Regulatory Requirements As A Management Responsibility. Examples Of Market-Specific Regulatory Requirements Include 21 Cfr 820, The Quality System Regulation For Medical Devices Sold In The United States, Enforced By The U.S. Food And Drug Administration (Fda), Or The Medical Devices Directive 93/42/Eec, Required For Doing Business In The European Union
• Controls In The Work Environment To Ensure Product Safety
• Focus On Risk Management Activities And Design Control Activities During Product Development
• Specific Requirements For Inspection And Traceability For Implantable Devices
• Specific Requirements For Documentation And Validation Of Processes For Sterile Medical Devices
• Specific Requirements For Verification Of The Effectiveness Of Corrective And Preventive Actions
The Promotion And Awareness Of Regulatory Requirements As A Management Responsibility. Examples Of Market-Specific Regulatory Requirements Include 21 Cfr 820, The Quality System Regulation For Medical Devices Sold In The United States, Enforced By The U.S. Food And Drug Administration (Fda), Or The Medical Devices Directive 93/42/Eec, Required For Doing Business In The European Union
• Controls In The Work Environment To Ensure Product Safety
• Focus On Risk Management Activities And Design Control Activities During Product Development
• Specific Requirements For Inspection And Traceability For Implantable Devices
• Specific Requirements For Documentation And Validation Of Processes For Sterile Medical Devices
• Specific Requirements For Verification Of The Effectiveness Of Corrective And Preventive Actions
Compliance With Iso 13485 Is Often Seen As The First Step In Achieving Compliance With European Regulatory Requirements. The Conformity Of Medical Devices And In-Vitro Diagnostic Medical Device According To European Union Directives 93/42/Eec, 90/385/Eec And 98/79/Eec Must Be Assessed Before Sale Is Permitted. One Of The Major Requirements To Prove Conformity Is The Implementation Of The Quality Management System According Iso 9001 And/Or Iso 13485 And Iso 14971. Although The European Union Directives Do Not Mandate Certification To Iso 9001 And/Or Iso 13485 The Preferred Method To Prove Compliance To Such Standards Is To Seek Its Official Certification Which Is Issued By Certifying Organizations Known As "Registrars". Several Registrars Also Act As Notified Body.
ISO 13485:2016 VS. ISO 13485:2003 VS. FDA 21 CFR PART 820: COMPARING THE DIFFERENCES AND CHANGES
Without going through an entire history lesson of the evolution of ISO 13485, know this:
• ISO 13485 evolved out of the general quality management system standard ISO 9001 and is specific to medical device industry.
• ISO 13485 is internationally agreed upon and defines a way to address common regulatory concepts.
• ISO 13485 is a voluntary standard and technically is not a required structure for a quality management system.
• ISO 13485 is not law.
• ISO 13485 does not define specific requirements for a company’s products and services.
• ISO 13485 does not define business requirements (such as financial requirements).
Without going through an entire history lesson of the evolution of ISO 13485, know this:
• ISO 13485 evolved out of the general quality management system standard ISO 9001 and is specific to medical device industry.
• ISO 13485 is internationally agreed upon and defines a way to address common regulatory concepts.
• ISO 13485 is a voluntary standard and technically is not a required structure for a quality management system.
• ISO 13485 is not law.
• ISO 13485 does not define specific requirements for a company’s products and services.
• ISO 13485 does not define business requirements (such as financial requirements).
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