ISO 13485 Certification Becoming More Essential for Medical Device Manufacturers
11 Jul 2014
With billions of dollars in contracts at stake, medical device manufacturers are pushing steadfast to conform to ISO 13485 regulatory requirements. Despite its widespread commercial implications, the popular standard is squarely focused on improving patient safety.
by Rogel Balbuena, Quality Assurance & Regulatory Affairs Manager
Value Plastics, Inc., a Nordson Company
ISO 13485, published in 2003 (officially designated ISO 13485:2003), represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The standard requires manufacturers to demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements. ISO 13485 supersedes earlier documents such as ISO 13485:1996, and ISO 13488 (also published in 1996), EN 46001 and EN 46002 (both published in 1997).
Authored by the International Organization for Standardization (ISO), based in Geneva, Switzerland – an umbrella organization composed of standards writing bodies in each of its 160 member countries – ISO is the world's largest developer of international standards which are recognized globally for their stringent criteria. Centered on improving patient safety, the importance of having a robust quality management system (QMS), like ISO 13485, ensures that the appropriate requirements are captured and properly documented. Medical device manufacturers are being pressured to comply, or the competitiveness of their company’s products will be compromised. For such companies seeking access to international markets, conformity with ISO 13485 regulatory requirements is becoming universally a prerequisite.
Growth in ISO 13485 Certification Escalates
According to the International Standards Organization, from 2004 through 2012 a total of 22,237 ISO 13485 certificates were issued worldwide throughout 93 countries. The United States leads with the highest number of companies that have become ISO 13485 certified, followed by Germany and Italy
From 2010 to 2012, company certifications rose a cumulative 18 percent for the three-year period, an average of 6 percent per year. In 2012 alone, the percentage of certifications doubled, showing a 12 percent increase in the number of organizations becoming ISO 13485 certified, up 240 percent over certifications in 2011. In 2012, Italy, the U.S. and the United Kingdom led with the highest number of medical device manufacturers becoming certified.
A 2011 survey of 900 medical device manufacturers, commissioned by global healthcare products company Covidien, showed 37 percent of responding companies became ISO 13485 certified to meet regulatory requirements. 31 percent became certified to support regulatory approval of products or services, and 28 percent of companies became compliant to meet customer requirements.
Achieving ISO 13485 Compliance
The ISO 13485 standard defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination.
The process of receiving certification under ISO 13485 requires an evaluation of all aspects of the company’s business processes and procedures to confirm conformity with the requirements outlined in the standard. Registration to these standards signifies that a manufacturer has implemented an integrative management system that complies with the applicable regulatory requirements for quality management.
To achieve ISO 13485 certification, a company must develop written policies for the following functions:
- Document and record controls;
- Internal auditing procedures;
- Controls for non-conformance;
- Corrective and preventative actions;
- Process and design controls;
- Record retention;
- Accountability and traceability.
Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:
- Access to markets that recognize or require the certification, including
Canada and Europe;
- Reduced operational costs by highlighting process deficiencies and
- Increased customer satisfaction by consistently delivering quality products and
systematically addressing complaints;
- Proven commitment to quality through an internationally recognized standard;
- Added transparency to the way complaints, surveillance or product recalls
ISO 13485 versus ISO 9001
Requirements for both ISO 13485 and ISO 9001 are among the most comprehensive of the approximately 19,000 standards established by the International Standards Organization, and serve as the model for quality management systems.
The fundamental difference between ISO 13485 and ISO 9001, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that the organization demonstrate that the quality system is implemented and maintained. Although generally harmonized with ISO 9001, ISO 13485 includes particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate to quality standards in medical manufacturing. Because of these exclusions, organizations whose quality management systems conform to ISO 13485 do not inherently gain conformity to ISO 9001, unless they were certified ISO 9001 prior. Therefore, many organizations maintain dual registration against both standards.
Specific differences in requirements and emphasis between ISO 13485 and ISO 9001 include:
- ISO 13485 sees the promotion and awareness of regulatory requirements as a
- ISO 13485 expects controls in the work environment to ensure product safety;
- ISO 13485 expects a focus on risk management activities and design transfer
activities during product development;
- ISO 13485 contains specific requirements for inspection and traceability for
implantable devices, and specific requirements for documentation and validation
of processes for sterile medical devices;
- ISO 13485 states that the company needs to maintain effective processes,
namely the processes specific to the safe design, manufacture and distribution
of medical devices.
As a matter of note, the U.S. Food and Drug Administration (FDA) does not formally recognize ISO 13485 certification, but the quality system requirements of the U.S. Good Manufacturing Practices overlap with the standard in many areas.
The ISO 13485 standard addresses most, or all, of the quality system requirements in markets including the United States, Europe, Australia, Japan and Canada.
Within the European Union, ISO 13485 is now considered to be the standard for medical devices, even though such devices have previously adopted Global Harmonization Task Force Guidelines (GHTF). GHTF guidelines are gradually becoming universal standards for the design, manufacture and export of medical devices. The ISO 13485 standard, adopted by CEN, the European Committee for Standardization, has been harmonized as EN ISO 13485:2012.
Compliance with ISO 13485 is a necessary step in achieving compliance with European regulatory requirements. The conformity of medical devices, according to EEC (European Economic Committee) decrees, must be assessed to acquire the CE mark and permission to sell the medical device in the European Union. The preferred method to prove conformity is the certification of the quality management system according to ISO 13485, ISO 9001 and ISO 14971 (which details the requirements for application of a risk management system for medical devices).
Patient safety and risk management remain a critical focus for government and private sector regulatory agencies, which are continually becoming increasingly stringent. Tightening standards and regulations, like ISO 13485, are pushing medical device manufacturers and suppliers to change their operating procedures and effect compliance with these new guidelines, or risk losing market share to competitors or even the ability to sell their products into specific markets.
Tens of thousands of medical device manufacturers and their suppliers internationally have already adopted ISO 13485, and thousands more are moving through the approval process at escalating rates. And ultimately, this is all for the benefit of the patients.
About Value Plastics, Inc., a Nordson Company
Value Plastics manufactures and markets an innovative line of fluid management components designed specifically for flexible tubing. Products include quick connect fittings, luer fittings, check valves, tube-to-tube fittings, threaded fittings, biopharmaceutical process components and blood pressure monitoring components. Value Plastics products find global application in demanding healthcare OEM, research and specialty industrial applications.
About Nordson Corporation
Nordson Corporation delivers precision technology solutions that help customers increase throughput, productivity and up-time, enable new products and features, and decrease material usage. The company engineers, manufactures and markets differentiated products and systems used for dispensing adhesives, coatings, sealants, biomaterials and other materials, fluid management, testing and inspection, and UV curing and surface plasma treatment, all supported by application expertise and direct global sales and service. Nordson serves a wide variety of consumer non-durable, durable and technology end markets including packaging, nonwovens, electronics, medical, appliances, energy, transportation, building and construction, and general product assembly and finishing. Founded in 1954 and headquartered in Westlake, Ohio, the company has operations and support offices in more than 30 countries. Visit Nordson at www.nordson.com, twitter.com/Nordson_Corp, or Facebook.com/Nordson.
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Will Stone, Communications Manager