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... gt;You can download the free Diagram of ISO 17025:2017 Implementation Process, the Project Plan as well as relevant white papers at https://advisera.com/17025academy/free-downloads/
If you are familiar with ISO 9001, the following may also be of interest - ISO 17025 vs. ISO 9001 â Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities//
... eproduct, and the safe creation of the product (provision). Do you identify thecharacteristics needed to safely make and use your product? This check shouldtake place during your design verification when you compare the design outputsto the design inputs.
You can learn more about the AS9100 distinction between designverification and design validation in the article: Design verification vs.design validation in AS9100 Rev D, https://advisera.com/9100academy/blog/2017/09/04/design-verification-vs-design-validation-in-as9100-rev-d/
... suggest you take a look at the free demo of our Disaster Recovery Plan at this link: https://advisera.com/27001academy/documentation/disaster-recovery-plan/
This article will provide you a further explanation about DRP and BCP:
... ce visits vs. certification audits - https://advisera.com/27001academy/knowledgebase/surveillance-visits-vs-certification-audits/
... ification vs Design Validation - https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
... /iso-9001-vs-iso-13485/" class="content-link Link" >https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
2. How to pass ISO 9001 stage 1 and stage 2 audit?
To pass ISO 9001 stage 1 and stage 2 audit, your organization must have a quality management system designed according to ISO 9001:2015 requirements and must be implemented and followed.
3. A Regulatory procedure and form is required that will meet both the standards requirements
You can add in your Quality manual cross-reference table for your Quality management system between ISO 9001:2015 and ISO 13485:2016.
Please note that in the template the risks are accepted by top management on behalf of the risk owners, i.e., the acceptance is made according to what is defined by risk owners, so this approach fulfills clause 6.1.3 (f), and approval of all risk owners is not needed.
This article will provide you a further explanation about risk owner:
This material will also help you regarding risk management:
What is a record versus a template vs a document? What makes a document controlled? What is the policy (template, record, document)? What is the log? Do the logs start with new dates every year?
... 7025:2005 vs. ISO/IEC 17025:2017 revision: What has changed? At https://advisera.com/17025academy/blog/2019/11/13/iso-17025-2017-vs-iso-17025-2005-key-changes-infographic/. You can also download the free whitepaper Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025.
The folloing ISO 17025 toolkit preview may also be of value - Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/