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ISO 13485:2016 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 and applicable regulatory requirements.
Does ISO require a quality manual?
An important note: many other quality management system standards based on ISO 9001 are still requiring a quality manual. If your standard requires one, then you must maintain a quality manual. The quality manual's purpose is to serve as the how-to document of your company's operational processes.
What is the difference between quality policy and quality objectives?
In short, a quality policy describes your business, what it offers and your commitment to delivering the highest quality product. Customer requirements are accounted for in the quality policy. Quality objectives are the goals linked to meeting customer requirements.
What is an ISO quality policy?
What is a quality policy? A quality policy is a brief statement that aligns with your organization's purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to meet applicable requirements (ISO 9001, customer, statutory or regulatory) as well as to continualy improve.
Can you be certified to ISO 13485?
Certification to ISO 13485 ISO does not perform certification. Read more about certification to ISO's management system standards.
ISO 13485 places a strong emphasis on awareness of regulatory requirements, including 21 CFR Part 820, the FDA's quality system guidelines for med device companies in the United States, and the Medical Devices Directive 93/42/EEC, which applies to medical devices in the European Union.
What is a quality policy ISO 13485?
ISO 13485:2016 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 and applicable regulatory requirements.
What are ISO 13485 requirements?
ISO 13485:2016 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 and applicable regulatory requirements.
Even though the Quality Manual is not mandatory, it is still very much necessary. Use this opportunity to increase the role of the Manual within your business management system.
iso13485 templates
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