Answer:
Yes, the standard that officially defines the maximum period between two surveillance audits is ISO 17021 (standard that defines requirements for bodies providing audit and certification of management system), and in accordance with this standard, surveillance audits shall be conducted at least once a year.
Since both ISO 14001 and ISO 13485 have new versions, it is best to conduct the transition for both standards at the same time. The problem is that the ISO 14001:2015 has adopted High Level Structure (with ten clauses) and ISO 13485:2016 is created according to ISO 9001:2008 so it kept the old clause numbering and this will make the transition and the integration more difficult that it should be.
The best toolkit for you is ISO 14001:2015 Documentation Toolkit (https://advisera.com/14001academy/de/iso-14001-2015-gap-analyse-tool/ 001-documentation-toolkit/) that contains all necessary documents together with some most frequently used ones. You can use your old Quality Manual and combine it with our new Environmental Manual that is a part of above mentioned toolkit. Practically you will need to identify common requirements of ISO 13485 and ISO 14001:2015 and merge them into joint sections and for different requirements you will have separate sections in the manual. We will also publish ISO 13485:2016 Documentation Toolkit soon so if you decide to purchase it later, you will get a big discount as our previous customer.
QMS in rice industry
Answer:
Implementation of ISO 9001 is the same for every industry, including rice production. You need to conduct gap analysis first to determine to what level your company is already compliant with ISO 9001 and what needs to be done to achieve full compliance.
Implementation of ISO 9001 is the same for any type of business including the hospitals, clinics or any other health institution.
You need to get the management buy in for the implementation first and then to assemble team for the implementation. Next step is to perform gap analysis to determine to what extent your company is already compliant with the standard and what needs to be done to achieve full compliance. Here you can find our free GAP analysis tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
Then you need to start creating necessary documents and implement new processes and actions in order to be compliant with the standard. For more information, see: ISO 9001 Implementation Diagram https://advisera.com/9001academy/free-downloads/
Once you complete the implementation, you need to conduct internal audit and management review to ensure that your system is fully compliant with ISO 9001:2015 . Finally you can hire certification body to conduct certification audit and issue your company the certificate.
The standard does not define who will perform the calibration and what qualifications must the person to perform calibration have. It simply says in the clause 9.1 "The organization shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained, as appropriate". However, the clause 7.2 states "The organization shall determine the necessary competence of person(s) doing work under its control that affects its
environmental performance and its ability to fulfil its compliance obligations".
This means that in case of internal calibration, the company itself may define requirements for competence of perople performing the calibration. If the company decides that no certificate is needed, than the person does no t need the certificate.
Great! And so to confirm, the standard does not require you to measure or monitor your training program?
Thanks!
The future of the cyber security
2. What Skill set should I gain to accomplish the domain knowledge
Answer:
Regarding the first question, from my point of view, the cyber security is the base for the protection of the future: IoT (Internet of Things), IIoT (Industrial Internet of Things), OT (Operational Technology), etc., so, careers related to cyber security will be very important, and currently they are on growth.
Regarding the second question, my recommendation is that you need courses, books, webinars, etc. about cyber security, although the information security is also fundamental for the cyber security, so our resources can be also interesting for you (it can be your first step to learn more about cyber security)
Before you hire the certification body you need to implement the standard first. Usual first step in implementation is to conduct gap analysis to determine to what level your company is already compliant with the standard and what needs to be done to achieve full compliance with the standard. Here you can find free GAP analysis tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
Next step is to create a project plan and define activities that need to be done, documents to be created and responsibilities for each activity. In case of bigger company with lot of locations, hundreds of employees, you will have to form a QMS team that will implement the standard, in case of smaller company , one man can be enough. For more information, see: How to choose a project manager for your ISO 9001:2015 implementation https://advisera.com/9001academy/blog/2016/01/12/how-to-choose-a-project-manager-for-your-iso-90012015-implementation/
Then you start implementing new procedures and documents into your existing company processes and create new ones. Once the system is implemented, you need to conduct internal audit and management review to make sure that your quality management system is compliant with ISO 9001. Finally, you can hire certification body to conduct internal audit.
Respuesta:
Si tu pregunta está relacionada con la auditoría de certificación, los auditores revisarán el cumplimiento de todos los requerimientos de la ISO 27001 o de la ISO 22301 en tu organización (teniendo en cuenta el alcance de tu sistema, lo cual significa que sólo se revisarán los procesos, áreas, departamentos, etc. involucrados en el alcance).
Con respecto a las entidades certificadoras, en Perú es fácil encontrar entidades que certifiquen ISO 27001 e ISO 22301, porque hay muchas empresas certificadas (por ejemplo las administraciones públicas), por tanto este artículo te puede resultar interesante "How to choose a certification body" : https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/
Finalmente, estos materiales también te pueden ayudar a conocer mejor la ISO 27001, como se implementa, y qué esperar de la auditoría de certificación: