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I can only speak about the key roles and responsibilities in the EMS. And within an EMS what can be closer to your question is the management representative role.
ISO 14001:2015 no longer mandates the appointment of a management representative. However, organizations are free to keep that role.
The following material will provide you more information about the management representative:
- What are the key roles and responsibilities in the EMS? - https://advisera.com/14001academy/blog/2016/11/21/what-are-the-key-roles-and-responsibilities-in-the-ems/
- ISO 14001: What is the Role of the Management Representative? - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/iso-14001-what-is-the-role-of-the-management-representative/
- Is the management representative still the best option to coordinate EMS according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/02/08/is-the-management-representative-still-the-best-option-to-coordinate-ems-according-to-iso-140012015/
- Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
I assume your question is related to our ISO 27001 Documentation Toolkit - the reason why these security policies are not listed in the Project plan is because first you have to complete your risk assessment in order to decide which of these policies will be needed.
In other words, not all of these security documents are needed - you should apply only the ones that are really needed to decrease your risks.
This article explains the logic: The basic logic of ISO 27001: How does information security work? https://advisera.com/27001academy/knowledgebase/the-basic-logic-of-iso-27001-how-does-information-security-work/
These materials will also help you regarding the flow of the implementation:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your
Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course
https://advisera.com/training/iso-27001-foundations-course/
I was wondering if you know if the ISO 13485 also covers lab equipment and instrumentation?
If I understand you correctly, you are asking if the requirements of ISO 13485: 2016 cover the maintenance of laboratory equipment and validation of the methodology in which that equipment is used. Yes, there are requirements in ISO 13485: 2016 for maintenance of the equipment (6.3 Infrastructure), how to define the work environment (6.4 Work environment and contamination control), and how to validate certain processes (7.5.6 Validation of processes for production and service provision).
If you need more information how requirements from ISO 13485:2016 are applicable, please read following free download Clause-by-clause explanation of ISO 13485:2016
https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
Should we have to have the lab equipment at the same QMS standard do you know? under the 13485
I am apologizing, but I do not understand your question. Can you please clarify it?
ISO 9001:2015 does not require a Quality Manual. You can confirm that in this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
So, you are free to have a Quality Manual designed according to your own organization’s requirements. I recommend that organizations develop a Quality Manual around these topics:
The following material will provide you information about the quality manual:
- ISO 9001 – The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/
- free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
Tools are great help while implementing ISO 20000 and/or ITIL. Use them to automate your procedures, record activities and create documents and records required by the standard. Here is an article that can help you with this topic: 5 things to beware of when selecting an ITSM tool https://advisera.com/20000academy/blog/2016/03/08/5-things-to-beware-of-when-selecting-an-itsm-tool/
But, there is no requirement that tools need to be "certified" on the standard or the framework (which is very arguable topic, anyways). Also, using two tools (for IT Service Management and/or ISO 20000 based SMS implementation) is counterproductive. Quite contrary, such approach will cause more problems than it will help.
Los pasos a seguir en la implementación y certificación son los siguientes:
1. Obtener el apoyo de la alta dirección que proporcione los recursos necesarios.
2. Identificar los requisitos de ISO 9001:2015 con los que tiene que cumplir la organización.
3. Definir el alcance de la organización, es decir los límites del sistema de gestión de calidad.
4. Definir los procesos y procedimientos necesarios para cumplir con la norma ISO 9001:2015 y asegurar resultados coherentes y adecuados con respecto a la calidad.
5. Implementar esos procesos y procedimientos que se han definido.
6. Llevar a cabo programas de formación y concienciación.
7. Elegir una entidad certificadora.
8. Operar el sistema de gestión de calidad y llevar a cabo las mediciones necesarias.
9. Llevar a cabo la auditoria interna
10. Realizar la revisión por la dirección.
11. Llevar a cabo las acciones correctivas pertinentes.
12. Realizar la auditoria de certificación, primero la fase 1 donde principalmente se revisa la documentacióny después la fase 2, que puede llevar varios días, donde se revisan los registros, procesos, etc..
En este artículo puede encontrar más información sobre los pasos a seguir - Checklist of ISO 9001 implementation and certification steps: https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
Para llevar a cabo el proyecto de implementación de la norma le recomiendo que primeramente atienda algún curso, como por ejemplo el de curso de Fundamentos ISO 9001:15 u otro más completo, como el de Implementador Líder (sólo disponible en inglés) - ISO 9001 Lead Implementer Course: https://advisera.com/training/iso-9001-lead-implementer-course/
Además estos materiales pueden ayudarle en la implementación y certificación de ISO 9001:2015:
- Libro - Descubra ISO 9001:2015 a través de ejemplos prácticos: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Curso de Fundamentos ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
ISO 9001:2015 does not require Business Continuity Management. However, due to an explicit customer requirement or due to a risk analysis outcome an organization can decide to do Business Continuity Management.
Some years ago, working as a consultant for a subcontractor of an electric power company, we had to apply Business Continuity Management to minimize disruption during and after important storms. We used as a basis for work ISO ISO 22301. In this article - The basics of ISO 22301 - https://advisera.com/27001academy/what-is-iso-22301/ - you can see that the 2019 version has a similar structure to ISO 9001:2015. Although not mandatory, as you can see in the article, a good disruption risk determination register and its assessment and business continuity plans seem to me very important for learning and improvement. Perhaps this other article could be useful for you - 17 steps for implementing ISO 22301 - https://advisera.com/27001academy/knowledgebase/17-steps-for-implementing-iso-22301/22301/iso-22301/
ISO 27001 and ISO 22301 are quite compatible, so that risk management, document control, internal audit, management review, corrective action, human resource management and measurement can be used in common for both of these standards.
These materials will help you:
You have to see that with the manufacturer of that device. There is no any restriction from the standard to do this, but you will need to seek permission from the manufacturer itself for this.
Here are the answers:
What are the concrete methods and ways to define a good ISMS scope
You need to identify in which part of your company is your most valuable information - see the details here: How to define the ISMS scope https://advisera.com/27001academy/knowledgebase/how-to-define-the-isms-scope/
what steps need to be taken while identifying the risk
Here's the article that will help you: ISO 27001 risk assessment & treatment – 6 basic steps https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-treatment-6-basic-steps/
and while writing the policies itself
Here are the articles that will help you:
These materials will also help you regarding ISO 27001 implementation:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your
Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course
https://advisera.com/training/iso-27001-foundations-course/