Many Global Regulatory bodies are including ISO
13485 into their requirements making the product suitable to the organization
to help in aligning with the regulatory requirements with other elements of the
standard.
Greater emphasis on risk-based
approaches
The ISO 13485 standard does not have a high-level
Annex SL structure. However, it requires risk-based approaches for quality and safety
protection for the compliance of the standard. There is a greater emphasis on
risk-based approaches as compared to the ISO 13485:2003.
Compliance with ISO 9001:2016 requires companies to
demonstrate the entire organization's Quality Management System (QMS)
processes.
Quality Management System (QMS)
The QMS consists of the fundamental set of
sequences, interactions, and resources to do business with a medical device
company.
The regulatory requirements vary from organization
to organization addressing the specific regulatory requirement of the market.
Companies can demonstrate more specific requirements
for validation of systems such as Enterprise Resource Planning (ERP), QMS, and
Laboratory Information Management Systems (LIMS) in the development or
maintenance of medical devices are in ISO 13485 Certification.
Documentation Requirements
Documentation of QMS processes, quality events, and
workflows should be developed with great care to ensure the safety of the
medical device. Documentation is about defining the processes that are being
followed.
Documentation assists your staff through the
manufacturing and support of medical devices and provides adequate training
based on ISO 13485 Certification.
Quality Manual
The Quality Manual is a critical part of your ISO
13485 Certification. It helps to ensure the scope of the organization and
documentation procedure.
Also, Check -->> 5 Things you
should know about ISO 13485 Certification
Medical Device File
The requirements for the various elements of a
medical device file are in Sub-clause 4.2of ISO 13485:2016.
- Keep demonstrating conformity supporting documents
- Include a description of each medical device
- Develop and maintain procedures for each medical device
- Develop and maintain specifications and procedures
- Document procedures for servicing
Document Control
In adherence to Section 4.2.4 (Control of
documentation) of ISO 13485 Certification, the QMS should be maintained to
ensure their usability, effectiveness, and adequacy for operation. Defined
controls are used to track unintended changes in documents.
Control of records
Records should be controlled to provide proof that
the required processes have been executed. It is vital to ensure the correct
understanding of records and documents.
Management Responsibility
Even the best of control over records will fail if
there is no complete support of the Executive management in maintaining product
safety. By embracing true compliance of ISO 13485 Certification they should
foster a culture of true quality across the organization. A small slip in their
approach to true quality can make it extremely difficult in maintaining
quality.
Resource Management
Section 6 of ISO 13485 standards identify the need to
allocate qualified staff, infrastructure, processes, and work environment to
ensure product safety to support business operations, and support services.
Product Realization
Product realization is a description to define
customer needs, design, and development, purchase, production, and field
assistance to develop quality and safe medical devices.
Also, Check -->> ISO 13485
Certification Cost
Many elements of the QMS and a variety of staff and
resources help your product realization efforts to have the following in place:
- Established quality criteria
- Defined processes
- Appropriate infrastructure
- Trained staffs
- Established verification in line with the products and
processes.
- Documented records providing evidence to product meet the
required specifications
Measurement, Analysis, and
Improvement
- Feedback is not just about customer complaints, the feedback is
the process clearly defined to gather data from production and
post-production activities.
- Assure that the product monitoring is being done
- More clarity about the monitoring a measurement of processes
for companies to comply with during the implementation of a quality
system.
- clarity about the nonconforming product before and after
delivery to ensure that the instances are each handled appropriately.
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