The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.
ISO 13485 requirements
In order to achieve ISO 13485 certification, you must develop written policies for the following functions:
Document and record controls
Internal auditing procedures
Controls for non-conformance
Corrective and preventative actions
Process and design controls
Record retention
Accountability and trace ability
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About the ISO/TS (Technical Specification) 16949:2009
The ISO/TS 16949 was jointly developed by the IATF members and submitted to the International Organization for Standardization (ISO) for approval and publication. The document is a common automotive quality system requirements catalog based on ISO 9001:2008, and specific requirements from the automotive sector. This document, coupled with customer-specific requirements defines quality system requirements for use in the automotive supply chain.
The IATF has developed a common registration scheme for supplier 3rd party registration to the ISO/TS 16949. The registration scheme includes third party auditor qualifications and common rules for consistent global registration. Some of the benefits of the IATF registration scheme include:
improved product and process quality
additional confidence for global sourcing
reassignment of supplier resources to quality improvement
common quality system approach in the supply chain for supplier/subcontractor development and consistency
reduction in multiple 3rd party registrations
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Addresses the environmental issues concerning the organization and extended to its surrounding.
ISO 14001:2004 is to demonstrated sand environmental performance by controlling the impact of the organization’s activities, products or services on the environment, taking into account their environmental policy & objectives.
ISO 14401:2004 is a new standard (late 1996) for Environment Management Systems. It is based upon ISO 9000 family of specification. The policy and objectives addresses issues related to
(i) Pollution of air, water and land.
(ii) Depletion of natural resources.
Benefits :
1. Reduction of waste hence cost savings.
2. Improved overall performance & efficiency
3. Better public perception of the organization to improved sales.
4. Reduction of impact of your activities, leading to more community support.
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Here we’ve “broken down” the updated ISO 9001:2015 standard to make it easier to understand and put into action. There are 10 major sections (or clauses) with supporting sections (or subclauses).
Each of these sections has a specific focus and expected implementation, which are seen as being key to achieving the outcomes expected by this widely-used quality management system (QMS). To successfully implement ISO 9001:2015 quality standard within your organization, you must correctly satisfy each of the following requirements outlined within it.
Section 1:Scope
Section 2:Normative References
Section 3:Terms and Definitions
Section 4:Context of the Organization
Section 5:Leadership
Section 6:Planning
Section 7:Support
Section 8:Operation
Section 9:Performance Evaluation
Section 10:Improvement
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The ISO 9001: 2008 developed by the International Organization for Standardization (ISO), specifies requirements for aquality management system (QMS), which can be used for internal application by organizations, regardless of whether the product or service gives it a public organization or private enterprise, whatever its size, for certification or for contractual purposes.
An ISO 9001 quality management system will help you to continually monitor and manage quality across all operations. As the world’s most widely recognized quality management standard, it outlines ways to achieve, as well as benchmark, consistent performance and service.
Managing quality with a standard that is recognized all over the world is necessary for all business sizes. ISO 9001 can help you:
save money
increase profit
win more business
satisfy customers.
Your company has worked very hard to achieve its ISO/QS, ISO/TS 16949 certification. Let the world know of your commitment to quality. Flag-Works‘ ISO/QS flags and banners allow your company to proudly display your achievement with a custom Flag-Works ISO/QS flag.
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If your company has reached ISO certification, then you should take a moment to celebrate this achievement! You need to tell your customers, vendors, employees and any other stakeholders of your accomplishment. Flag-Works is proud of all that your company has accomplished. Your company deserves to fly an ISO Flag and we are the Flag maker that can help you.
Flag-Works’ ISO/QS flags and banners allow your company to proudly display your achievement with a custom Flag-Works ISO/QS flag. We make our ISO/QS flags to order so that you may choose your color scheme.
The flags below have appliquéd ISO letters/numbers, your ISO flag reads correct on the front and reverse on the back. Flags are finished with canvas heading and brass grommets- and we only use 100% 200-denier SolarMax nylon. We also have ready made ink-jet designs below. Pick one today!
Has all the hard work paid off with an ISO certification for your company? Well, hard work has its rewards achieving its ISO/QS, ISO/TS 16949 certification is the first step. Now, let the world know of your commitment to quality. Flag-Works’ ISO/QS flags and banners allow your company to proudly display your achievement with a custom Flag-Works ISO/QS flag. We make our ISO/QS flags to order so that you may choose your color scheme.
These flags have appliquéd ISO letters/numbers, your ISO flag reads correct on the front and reverse on the back. Flags are finished with canvas heading and brass grommets- and we only use 100% 200-denier SolarMax nylon. New designs are now printed on nylon with rich vibrant colors. These flags have been very well received. We try and keep plenty on the shelf, for your needs. For all your flag needs visit Flag-Works over America