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ISO 13485

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS

Introduction:

ISO 13485 specifies requirements for a quality management system 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. Putting the regulatory considerations aside, implementing an ISO management system standard into your business represents good management practice, or in the case of medical devices “Good Manufacturing Practice (GMP)”. By implementing ISO 13485, an organization becomes a better bet for their suppliers. Not only they have implemented important controls directly related to medical device manufacturing, but also, they have provided efficiencies and effective management through:

  • A documented approach to management
  • Policies, objectives, and planning
  • Control of documents
  • Control of records
  • Reviews
  • Internal audits
  • Product non-conformances and continual improvement

What is the role of the customers in all of this? Of course, the customer is also king, and all the regulations in the world make no difference to your business if you can’t attract and satisfy your customers enough. Many companies can design product and promote, but it is the consistent quality and attention to customer satisfaction that brings long-term success in the market. Customer satisfaction, of course, is a prime goal of the ISO 13485 standard; no wonder it’s appealing to customers. Proving yourself as a good and consistent supplier to your customer can be improved by certification to an ISO management system standard. As the importance of compliance and satisfaction grows, you will be able to draw the attention of a number of customers who will not work with non-ISO certified organizations. Many organizations are finding that no matter how good their product is, customers need more reassurance, they want their suppliers to be certified. Moreover, many organizations are finding that losing even one contract can well pay for the cost of implementing good management practice and getting certified. If your management system was well documented and implemented, you just might even enjoy life a little more with the knowledge that your business is in safe hands and operated, as it should.

For medical device manufacturers or suppliers who are looking for opportunities to grab new markets, conformity with regulatory requirements is a mandate. If you are one of those entrepreneurs who want to avail the competitive advantages in the medical device manufacturing industry, ISO 13485 certification is an ideal choice for you!

Benefits of implementing ISO 13485 Certification to your Customers:

  • Quality ensured medical devices
  • Improved Customer Satisfaction
  • Improve your process
  • Create a culture of continual improvement
  • Ability to Contract with Larger Companies
  • Increased profit margins
  • Improved product safety
  • Cost Savings
  • More Effective Risk Management
  • Increased likelihood of meeting Customer Requirements
  • More Effective Risk Management
  • Increased profit margins
  • Increased access to worldwide markets


What kind of Organizations can go for ISO 13485 Certification?

Any Organization who is into one or more life cycle stages of Medical Devices can get certified to the ISO 13485 Standard. Organizations involved in the concept design, development, production, storage, sales/distribution, installation, servicing, final decommissioning, and disposal stages of medical devices can get certified to the ISO 13485 Standard. Moreover, Organizations can get certified to the ISO 13485 Standard irrespective of their size (number of personnel) and the type of Organization. Our ISO 13485 Consultants will help you with the process steps to get certified.

How can Neozenith help?

  • Gap analysis for each and every activity of the organization and preparation of the detailed report.
  • Preparation of applicable documents required by ISO 13485, based on the detailed study of all activities of the organizations, such as:
  • ISO 13485 Quality Manual.
  • ISO 13485 Quality Procedures (mandatory procedures required by the standard).
  • Identification of applicable regulatory requirements and ensuring compliance with the regulatory requirements and as per customer requirements.
  • Standard Operating Procedures (SOPs) to control identified activities having risk potential to the human during the use of such medical devices;
  • Formats to establish the objective evidence of implementation and to ensure control over all the activities;
  • Training on ISO 13485 standards to all employees within the organization,
  • Virtual and on-site support in effective implementation of the ISO 13485 system by periodic visits till ISO 13485:2016 certification.
  • Conduct an internal audit to check readiness for the certification.
  • Certification audit – Stage 1 and Stage 2
  • Submission of the action plan on audit observations
  • Review of reports by the certification authority and awarding the certificate to the organization.