Medical Devices (ISO 13485 and FDA CFR 21)
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ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (www.iso.org), an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, headquartered in Geneva, Switzerland.
Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The Standard excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements so organizations whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS also conforms to all the requirements of ISO 9001. QMSs are not equivalent to product and service standards.
If any requirement(s) is/are not applicable due to the nature of the medical device(s) for which the QMS is applied, the organization does not need to include such a requirement(s) in its QMS. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS.
Learn from Omnex's QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with disciplined problem solving methods.
The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2003 and their respective regulatory requirements. The agencies are working to update the requirements to the new ISO 13485:2016 standard.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
The FDA along with Therapeutic Goods Administration of Australia, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan's Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in a MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.
Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact us for more information on how Omnex can help your organization.
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Implementation Support and/or Assessments
Omnex provides management consulting that elevate the performance of client organizations
Training and Workshops
Robust Quality Management Systems processes and Risk based, prevention based new
product development is receiving a large focus in the medical devices market. The
driver is the FDA who has issued more warning letters in 2010 and 2011 than the
prior 10 years. The FDA issued 9,910 483s in 2010, which is at least a 10-year high
based on available data. Among these, the top three issues were quality unit deficiencies,
inadequate batch failure investigations, and lack of follow-up procedures and an
escalation process with deadlines seem to have made the medical device industry.
Disciplined Problem Solving (8D)
Integrated Management Systems
Integrated Management Systems (IMS) is the integration of QMS,
EMS, OHSAS and other regulations / standards and requirements into a single management
system. IMS fosters the approach that an organization should establish one integrated
system that is best for the business and not set up separate, often duplicate, processes
or documentation to satisfy each management standard. IMS contains company-wide
processes that conform to various management system standards such as ISO 13485,ISO
14001, and OHSAS 18001 but are primarily established in support of the business
At Omnex, integration means developing common organizational processes based on
standardized work flows, conducting integrated risk analysis (using FMEAs and Control
Plans for quality, environmental and health and safety risks) and conducting integrated
audits. At Omnex, we are continuing to pioneer ever more effective and efficient
ways of defining, implementing and auditing integrated management systems.
Integration and standardization not only reduce confusion and redundancy in the
workplace, but cost an estimated 50% less to implement and most importantly
cost 50% less to maintain. Furthermore, the cost for registration is reduced by
as much as 33%.
Omnex has been implementing integrated management systems since the 1990s, beginning
with the integration of QS-9000 and ISO 14001 in the Americas for Yazaki. Since
then, we have integrated ISO 9001, ISO 14001 and OHSAS 18001 for organizations around
the world including General Motors and TRW. Lately, we have integrated ISO 9001
and Food Safety Management Systems including an implementation where Food Safety,
Quality (ISO 9001), Environmental (ISO 14001), and Health and Safety (OHSAS 18001)
were integrated into one management system. Omnex recently helped Swiss Colony
a 100 year-old Food Catalog and Bakery implement FSMS and QMS standards in a record
six months that included QOS/BOS and Phase Gate New Product Development methodologies
and 8D Problem Solving techniques.
Omnex provides training for top management in the understanding and integration
of multiple integrated management systems, as well as the worlds only lead auditor
course in Integrated Management Systems (ISO 9001, ISO 14001 and OHSAS 18001).
Click here for more information on Omnexs approach to Integrated Management Systems
Omnex Methodologies and Practices
Omnex offers training for each of the different methodologies as shown in this link.
Keep in mind, some of these methodologies may be known by different names within
Omnex specializes in the following methodologies:
Click here to view Omnex Training and Workshop Offerings
Omnex can help you conduct an ISO 13485:2003 Discovery Analysis (or Assessment)
or conduct a Best-In-Class assessment to assist your company in making
process improvements that results in efficiency and savings.
Omnex will conduct a Discovery Analysis during an initial assessment. Omnex will
study your current processes to see the gaps in the systems as well as review Best-In-Class
practices depending on the scope of the assessment. Omnex assessments always focus
on savings and improvements within the organization. The last day of the assessment
centers around feedback and planning with the customer team. An implementation plan,
team, and next steps are completed as a part of the Discovery. Of course, this can
also be conducted at the beginning of an implementation, when the standard is revised
or when the customer is ready for an overhaul of their systems.
If an organization receives a FDA 483 or a citation, the first thing Omnex will
do is conduct a comprehensive assessment and determine overall company risk. Based
on the findings a comprehensive improvement plan will be developed. Some of the
FDA findings and Omnex improvements are as follows:
- Quality unit deficiencies equate to QMS improvements that introduce prevention based tools.
- Batch failure investigations
equates to the better disciplined
problem solving methods
- "Lack of follow up" procedures could point to two
areas that need work one is top management and their follow through capabilities
second, company-wide follow through using the discipline of process, product and system audits.
- Escalation is something that can be
built into multiple processes in the QMS. Surefire methods to institute escalation
processes is by implementing a EwIMS that has programmed into it "reminders" and "escalation".
Omnexs core strengths are spelled out in the 12 methodologies in
which we specialize. Each of these practices are Best In Class practices
that can be implemented based on the needs of a specific organization in any industry.
Let us know how we can help you!