United States
+1.615.398.2939
Australia
+61467878151
United Kingdom
+447551039473
United States
+1.615.398.2939
Australia
+61467878151
United Kingdom
+447551039473
Comparing Quality Management Systems (QMS), ISO 13485 and ISO 9001 are two major standards that organizations look at. Although both theories focus on the improvement of the operational effectiveness and satisfying the customers, they are used within various spheres of industries and including medicine with its specific legislation.
Key Differences
Focus and Scope
ISO 9001 can be described as a large quality management system that is implemented in different industries. It focuses on its customers and the notion of improvement. For organisations that embrace the implementation of ISO 9001, this gain leads to enhancement of a numerous and well-structured framework on quality processes and stakeholder relationships.
On the other hand, which only provides requirements for medical device manufacturers and related services. It is based on ISO 9001 however it has extra criteria which are put in place to solve the medical industry regulatory and safety issues.
Some of the requirements that organizations seeking to seek accreditation to ISO 13485 certification must show include showing that they are capable of providing medical devices that meet the necessary quality standards of their customers and the regulations while at the same time showing commitment.
Regulatory Compliance
One major difference that was identified comes in the translation of the regulatory compliance factor. ISO 13485 certification service is chosen to assist organizations in reaching specific requirements provided by the relevant authorities like the FDA in USA or EMA in Europe. Minimum requirements set in ISO 13485 help in getting approvals and certifications thus making it important for medical businesses which intend to market their products.
However, the ISO 9001 specification does not contain reference to the need to address legal requirements. That it further augments the quality management system does not include the more rigorous criteria for the certification of the medical devices, like risk management and post-market monitoring.
Documentation and Quality Control
This section presents the findings of documentation and quality control for the study.
In comparison, ISO 13485 demands more documentation than that specified by ISO 9001. This has to do with specific methods of designing control, production and even after production processes. Documentation that is required for obtaining ISO 13485 certification service is very important to maintain traceability while fulfilling the life cycle requirement of a medical device.
In contrast to the above view, ISO 9001 provides more flexibility in terms of documentation which could be especially helpful for those organizations which do not work within healthcare sector. However, with flexibility comes corresponding problems of inconsistency in the management of quality.
So, While ISO 13485:2003 and ISO 9001:2000 both have an important role to play in the generation of quality management, they respond to the different requirements of the sector. The medical businesses must know all the procedures related to, the advantages of, and the consequences that come with each standard.