This is our second article in a series of Articles on: Branching out - Other Standards based upon ISO 9001. This is #2 of 2 on ISO 13485 - Medical Standards.
Who is requiring companies to be ISO 13485?
ISO 13485 is recognized in most major markets (including the EU, US, Canada, Japan, and Taiwan). It is very likely that it will be widely adopted by other regulatory authorities around the world. You can get it all with one single audit!
ISO 13485 it is based on ISO 9001. ISO 13485 does not include the customer satisfaction and continual improvement clauses. If an organization is certified to ISO 13485, it does not automatically meet the requirements of ISO 9001.The company should separately acquire ISO 9001 certification also. This free tutorial Compares ISO 9001 & ISO 13485.
ISO 13485 certification does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements. Here is an overview of the Terms & Regulations for Medical Devices.
Why should my organization become certified to ISO 13485?
ISO 13485 also incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system including:
1. Expanded market access gives you:
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You will be able to work within many countries where ISO 13485 is a regulatory requirement and with many organizations where it is a contractual obligation or expectation.
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Your company will be able to win more business opportunities – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
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The certification serves as a proven credential as it is an independent verification against recognized standards.
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ISO 13485 is globally recognized as the “best quality practices” from organizations within the medical device industry.
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This is quality system which satisfies the rigors of an independent, external audit and lays stress on additional safety, regulatory, and quality concerns specific to the medical device industry.
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This certification helps to create a systematic procedure using which the organizations monitor, measure, and analyze their processes and customer feedback.
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This certification gives you a Shorter Sales Cycle - less time is needed to earn your prospective customers' trust and confidence.
2. Overall performance improvement – Once you are certified QMS, it helps you to improve your products and processes. This certification is based on a uniform and widely accepted system of process control that gives you:
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ISO 13485 certification means higher customer satisfaction .The delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements satisfies the customer.
• Striking improvement is noticed in stakeholder relationships – including staff, customers, and suppliers.
• ISO 13485 helps you to understand how statutory and regulatory requirements impact an organization and its customers. Thus it helps in legal compliance.
• Certification like ISO 13485 enhances the image of the company in the eyes of customers, employees, and shareholders and all.
• You need this certification to provide improved performance in areas such as increasing sales, timeliness in getting products to the global marketplace, reducing costs, decreasing number of errors, lessening wastage, better utilization of time and resources, and lowering product failures.
• Helps in improved risk management – this is done through greater consistency and traceability of products and using risk management techniques.
• ISO 13485 is a framework for implementation of actions (where necessary) which ensures achievement of planned result and maintaining effectiveness of those processes which are applicable to customer, quality and regulatory requirements.
An ISO 13485 certification means ability of your organization to do business in the highly regulated sectors. It demonstrates your organization’s commitment to quality, customers, and your willingness to work towards improving efficiency.
Here is a "Benefits & Costs of ISO 13485" PowerPoint with additional information.
Our next issue of "Branching out - Other Standards based upon ISO 9001" will discuss ISO 14001 - Environmental Management - which isn't a quality standard but is still based upon ISO 9001 and the Plan Do Check Act structure.
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