Two worldwide standards that stand out in the context of quality management are ISO 9001 and ISO 13485 Certification. They are both quite popular but they meet different needs of different sectors and have certain standards.
This is where we at I3CGlobal come in to assist companies to acquaint themselves with these standards for compliance and effectiveness purposes.
ISO 9001: What is the standard?
Any organization and any kind of industry is using a generic model of a standard as is ISO 9001. With respect to its core principles, they include improvement in customer satisfaction, searching and determining key business processes, and avoiding decline in that key business process.
It focuses on methodological subjects: oversight performance and quality in all organization operations.
How does one define ISO 13485?
On the other hand, ISO 13485 is designed especially for the medical device sector. It is based on ISO 9001 but adds a number of specific requirements for medical device safety, risk management and the legal requirements necessary for compliance. The safety of the medical equipment used in healthcare facilities is guaranteed by these criteria.
ISO 9001 and ISO 13485 Differences
- Industry Emphasis:
- ISO 9001 management standard applies to a wide and extensive range of organizations.
- ISO 13485 is special for the medical devices; it comprises safety factors and regulatory compliance.
- Regulatory Requirements:
- ISO 9001 the international standard on quality management specification aims at customers and organization’s expectations of improvement in the processes.
- ISO 13485 augments detailed regulatory compliance that checks and ensures that the developed products match market and safety requirements.
- Risk Management:
- Risk based approach is promoted in ISO 9001.
- ISO 13485 specifies the use of risk management procedures related with the safety of the device.
- Documentation and Traceability:
- For undocumented records, ISO 9001 does not call for extreme traceability.
- ISO 13485 requires documentation and traceability in order to prove that the product is safe.
Selecting the Proper Standard to Your Business
Because of this, any business must make a significant choice between ISO 9001 and ISO 13485. A company working with the medical device industry cannot proceed with its business life without ISO 13485, to meet regulatory affairs and to provide safe products meeting the medical device standards.
To the other companies in other industries, ISO 9001 provides the companies with a flexible structure of enhancing quality management and customer satisfaction.
When a company secures certification in either ISO 13485 or ISO 9001, not only is efficiency increased internally but there is also an increase in credibility in the market.
The customers and the partners today are willing to deal with companies that conform to the standard quality standards. Further, these certifications also provide an entry point to other markets especially in markets that are growing strictly like the medical device market.
Conclusion: The Roadmap to Quality with I3CGlobal
Comparing ISO 13485 vs 9001, there are two different approaches to enhance the quality management based on the type of field of work. Still, ISO 13485 is really critical for firms in the medical device industry, while, on the other hand, ISO 9001 is globally recognized for quality.
Knowing each of these and how to execute it can assist an organization to make effective decisions that would benefit the particular organization.
At I3CGlobal we have focused our services in the certification of your company so that you can fulfil all the requirements of the regulations and quality benchmarks.
Are you ready to go to the next step in management of quality? Get in touch with I3CGlobal today and let us assist you in going for the certifications that count in the success.
