By: Company certifications to ISO grew by approximately 14% during last year in comparison to other standards, such as ISO 9001, AS 9100, and ISO 14001, in which certifications grew by approximately 3% – 4%. This is attributed to regulatory bodies for the medical devices industry and the growth of that sector. Typically organizations seeking ISO 13485 certifications are within the supply chain of the licensed medical device manufacturer, and are already certified to ISO 9001:2008. This is a 5 part series that identifies key requirements of ISO 13485 that are not requirements of the ISO 9001:2008 standard. This series does not include regulatory requirements set by regulators such as FDA, Health Canada (CMDCAS), Brazil (ANVISA), or Australia (TGA). This will hopefully be presented in the near future. The following is a breakdown of what will be included in this series: Part 1: Documentation requirements Part 2: Management commitment Part 3: Resources Part 4: Product realization Part 5: Measurement, analysis and improvement Part 1 of 5: Documentation Requirements Documentation requirements and established procedures per ISO 9001:2008 are limited to the quality manual (4.2.2), control of documents (4.2.3), control of records (4.2.4), internal audit (8.2.2), control of nonconforming product (8.3), corrective action (8.5.2), and preventive action (8.5.3).

In short, a quality manual and six required procedures. Documentation requirements for ISO are much more extensive. Скачать I68regenerator Fifa 14.

Designing Programmes Karl Gerstner Pdf Editor here. In addition to the six required procedures listed above, there are 16 other required procedures, 7 documentation requirements and 1 requirement for establishing a device master record (DMR). Below is a listing of the documentation requirements per ISO.

Dec 13, 2017. Clear misunderstandings of the ISO clause 7.5 for production and service provision, see how to implement it and increase customer satisfaction. Control of the production process is a key for manufacturing a product that is compliant with the specification, and this can be achieved through.

Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems. How to Implement ISO 13485 Updates • 1.