ISO 13485 | Medical Device Quality Standards | NQA
Medical Devices & Services

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With significant expertise in the medical device manufacturing sector, NQA is your choice is certifications and medical standards.

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There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.

An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system.

MEDICAL DEVICE MANUFACTURING STANDARDS

Several management standards are applicable to medical device manufacturing. Read on for a brief overview of the most relevant, as well as information about the role NQA can play in getting your organization certified.

ISO 9001

ISO 9001 is the  general standard for quality management. It is not industry-specific and as such can be successfully adopted by any organization that wishes to implement more rigorous system based on a continuous improvement cycle. For medical device manufacturers, ISO 9001 engages management in the quality control process, helping make organization-wide changes that keep costs down, improve accountability, facilitate growth in a more responsible manner and simplify regulatory compliance.

The most recent version of ISO 9001, published in 2015, is based on the high-level Annex SL directive, using a common vocabulary and structure that makes it easier to attain compliance with other, more specific standards.

ISO 13485

ISO 13485 is the quality management system specifically designed for medical device manufacturers. It expands on and refines the framework established by ISO 9001, with the aim of harmonising regulatory requirements. Compliance with ISO 13485 helps with overall quality control, traceability, process validation and risk management.

Manufacturers that attain ISO 13485 compliance will have an easier time bringing their products to international markets. Compliance can also streamline your processes and ultimately help you run a more efficient, profitable and risk-averse operation. 

ISO 14001

Sustainability is an important concern for all manufacturers trying to run a leaner business. Implementing an environmental management system compliant with ISO 14001 standards can help medical device manufacturers cut down on waste, conserve energy and reduce their overall carbon footprint – important benefits when working with complex global supply chains.

Like ISO 9001:2015, the most recent version of ISO 14001 is based on the Annex SL structure. As a result, if you already have a certified quality management system in place, adopting ISO 14001 can be relatively straightforward. When your environmental, health and safety, and other protocol share requirements, your business is better positioned to succeed in a competitive industry.

ISO 50001

ISO 50001 complements ISO 14001 by offering a specific standardized system for energy management. With it, medical device manufacturers can reduce their operating expenses and improve their overall energy efficiency – important benefits that can enhance their reputation and facilitate regulatory compliance.

ISO 18001

Pharmaceutical and medical device manufacturing often presents specific occupational risks, particularly when working with the advanced technology found in imaging equipment and other products. While ensuring the safety of your team is essential, it can’t come at the expense of productivity.

ISO 18001 outlines requirements for occupational health and safety management systems that can be employed in the medical device industry to reduce risk and improve accountability while positioning your organization for sustainable growth. Use it to reduce accident rates and related liability issues on an ongoing basis.

ISO 18001 is set to be superseded by a new standard, ISO 45001, in 2017. Doing the groundwork now to become ISO 18001 compliant will make it easier to adopt the new requirements when they are published – contact NQA directly for details.  

ISO 27001

As medical devices become more sophisticated, cybersecurity is an increasing concern. The growing market for smartphone-based health-monitoring apps, as well as connected devices in the diagnostic room and operating theatre, requires proactive information security standards. Add to that the risk of your valuable intellectual property being compromised in a data breach, and it is clear to see why ISO 27001 has become a critical standard for health care and medical device manufacturers.

ISO 27001 contains tools that can help you assess and manage cybersecurity risks in your organization. It is based on a set of internationally recognized best practices that are not specific to any one platform or software package. Becoming ISO 27001 certified will position you to adapt accordingly as the threats against your enterprise change, and to maintain continuity in the event of a cybersecurity incident.

IMPLEMENTING ISO STANDARDS

NQA has significant expertise in the medical device manufacturing sector and is ideally placed to assist clients to successfully implement ISO 13485 and supporting standards. Our clients in the medical sector include New England Biolabs, Pac-Dent International, GESUS New England, Tecomet, and RR Donnelley Banta Global.

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