Understand the requirements of ISO 9001: so you can conduct a successful audit. Ciel Consulting provides hands-on learning experience to prepare you for real-life auditing situations. This Global-certified course meets the training requirements for Global Quality Management Systems Lead Auditors, Auditors, and Provisional Auditors. ISO 9001 Quality Management Systems Training Courses. Course, an ISO 9001:2015 IRCA-accredited Lead Auditor course and many more. This two-day IRCA Certified PT233 QMS ISO 9001:2015 Auditor Transition training course is.
What is ISO?ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, published in 2003, The current ISO 13485 effective edition was published on 1st March 2016, that represents the requirements for a comprehensive “management system for the design and manufacture of medical devices”. While it remains a stand-alone document, “ISO 13485” is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO requires only that they demonstrate the quality system is implemented and maintained.ISO provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.Your ISO certificates can help you enter into EU market.While it is based on ISO 9001:2008, ISO does not include the customer satisfaction and continual improvement clauses – so an organization certified to ISO does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately.
Compliance with ISO also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements. Why should my organization become certified to ISO?Your quality system’s conformity with ISO can help you reap the benefits of:.
Expanded market accessNational regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others. Reduced cost of salesyour certification establishes your company’s credibility and commitment to quality from day one. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence. Improved overall performanceBased on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.Other specific differences include:.
The promotion and awareness of regulatory requirements as a management responsibility.