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Hello, we purchased the ISO13485 kit from you guys and I have a question.. We have a QMS for our NIOSH/21CFR-820 doing some research the QMS requirements are very similar, the ISO13485 is more company operations and the NIOSH/21CFR-820 is both operations and product. Since we already have the NIOSH/21CFR-820 can we use this QMS for ISO13485?
... cuenta que se utiliza un análisis de brechas para evaluar su situación actual con respecto a los requisitos de ISO 27001, por lo que puede usarlo ahora mismo. En este momento, el análisis de brechas le dará una idea del esfuerzo para implementar el estándar.
Para obtener más información, consulte:
... better to perform the risk assessment during the implementation).
Please note that a gap analysis is used for you to assess your current situation regarding ISO 27001 requirements, so you can use it right now. At this time the gap analysis will give you an understanding of the effort to implement the standard.
For further information, see:
... ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/
What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/ and the white paper
Clause-by-clause explanation of ISO 17025:2017 available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025
... 7001 2013 vs. 2022 revision – What has changed? https://advisera.com/27001academy/blog/2022/02/09/iso-27001-iso-27002/
This material can help you:
What are the main diffrences between ISO 27001 and NIST? How can I know what is best for any organization?
Most changes in ISO 27001:2022 are related to Annex A, reorganizing controls from the 2013 version and adding 11 new controls. Contents of the ebook are still valid to help implement an ISMS ISO 27001 compliant.
These materials will give you an understanding of the changes:
For a new startup , we are hiring a CISO. At the same time we need help with the implementation of ISO 27001 as well. Is it fair to expect a CISO to implement new ISO policies, procedures, training, asset risks and risk maps. On a scale of 1-100, we are about 30 in terms of implementation. Question is do we still need a consultant for implementation. We are about to interview candidates for CISO, What can we ask him to convince ourselves that he can do both. Do they generally come with the implementation skill or they would be asking for an additional consultant
Appreciate some feedback on this. I enjoy reading your book a lot.
... . 500 employees because it would make your implementation unnecessarily complex.
You can access the ISO 27001 Gap Analysis Tool at this link: https://advisera.com/27001academy/free-iso-27001-gap-analysis-tool/
For further information, see:
- ISO 27001 gap analysis vs. risk assessment https://advisera.com/27001academy/knowledgebase/iso-27001-gap-analysis-vs-risk-assessment/