ISO 13485 Certification 101 | Everything You Need to Know
What is the ISO 13485 certification? It is a common question found online that lacks exact answers. This certification enables a company to establish a strong brand image by ensuring customers with the fact that each product and service offers the optimum quality. The ISO 13485 was designed for medical device manufacturing and distribution companies. The aim of this certification is to ensure that companies deliver high-quality devices for the fast accomplishments of patients from time to time. The certification offers numerous benefits that ensure market sustainability for companies. As the market of medical device production and distribution is increasingly competitive, companies need the shield of the ISO 13485 to stand tall in the race.
The certification is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices. It is designed to ensure that companies meet regulatory requirements and consistently provide medical devices and related services that meet customer and applicable regulatory requirements.
The following blog discusses different aspects of the certification that one must know before proceeding with the accreditation. Starting with the fundamental purpose of the ISO 13485 This blog will decode the requirements, processes, and benefits of getting accredited by the international quality management system for medical devices.
What is the purpose of the ISO 13485?
Quality Management System:The ISO 13485 focuses on the establishment, implementation, and maintenance of an effective quality management system specific to the medical device industry.
Compliance:It ensures compliance with regulatory requirements in the medical device industry.
What are the clauses of the ISO 13485?
• The clause structure of ISO 13485 looks like the following:
• Scope of the program
• Normative references
• Terms and conditions
• General requirements for quality management
• Management responsibilities
• Time-to-time resource management
• Measurement, observation, analysis, and continual improvement
To achieve compliance, these clauses should be met with efficiency and productivity. At the end of the system implementation process, each requirement should be fulfilled to justify the objectives.
The three Requirements of the ISO 13485
1.Documentation: Requires extensive documentation, including procedures, policies, and records.
2.Risk Management: Emphasizes risk management throughout the product life cycle.
3.Continuous Improvement: Encourages continuous improvement and effectiveness of the QMS.
What is the process for certification?
• The process starts with detecting the gap between the present system and the objectives. It is called the gap analysis method, which decodes the root causes of the existing flaws. According to the findings, strategic actions are incorporated into daily operations for timely improvement. The aim of the gap-filling process is to ensure compliance with the objectives and the clauses mentioned above.
• As soon as the gap is filled and the flaws are rectified, it is time to conduct an audit to see if the clauses have been aligned and met properly. The system progress is monitored and documented in this step.
• The assessment process ends with a readiness review, that detects any further complications in the system and determines the readiness.
What are the top benefits?
• Market sustainability
• Customer acquisition
• Customer loyalty
• Steady and increasing profit margin
• Market exposure
• Cost-effective manufacturing and distribution
• Low wastage
• Employee morale is increased
• Brand reputation strengthened
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