I have also some question during consulting process but I have to study more on the spirit of ISO 9001-2015. But now I would like to give you question relating to item Risk-based thinking as follows:
1. Does organization shall address the risk for the realization or for all process or only for critical process ?
2. Risk-based thinking for all processes of system is described by establishing a documented information under support procedure ?
3. Does Risk-based thinking is a new thinking to be set in mind for personnel having work affecting quality and then records from problem solving, taking decision, eliminating risk,...can demonstrate that. So that no need to have procedure to analyse risk as well as for risk evaluation ?
Once again thanks a lot your support.
Answers:
1. The organization needs to consider entire context of the organization not only the processes, but it doesn't mean that you need to identify risks for each process. You can conduct a global assessment on the organizational leve l and that can be enough, then again you can go into details, it depends on needs of organization, the standard allows a lot of freedom regarding this requirement.
2. Documented procedures exist to prevent risk of noncomplying with the activities in the processes and in that sense they are used for avoiding risk. Also some activities like inspection or monitoring certain parameters within the process serve as precaution. But not all processes carry such risk within them so there doesn't have to be a documented procedure for each process.
3. Addressing risks and opportunities belongs to planning phase of the QMS so it is a requirement related mainly to top and mid management not employees. The management of the company should think about risks and opportunities related to the QMS and take actions to address them.
Answer:
Yes, one of the Design Coordination Manager tasks is to ensure that overall service strategies are reflected in the service design practice and, additionally, that design of the service solution meets business outcomes and customer requirements.
Read the article "Design coordination process – creating a solid foundation" https://advisera.com/20000academy/blog/2013/07/31/design-coordination-process-creating-solid-foundation/ to learn more.
How to integrate ISO 27001: 2013 with HIPAA security rules
Thank you for explaining. My understanding is HIPAA security rules can be easily accommodated by implementing ISO 27001: 2013 in letter and sprite. Because HIPAA security rules specify three requirements i.e: Security should be managed Administratively, technically and physically and this is pretty much the same concept of ISO 27001:2013 standard.
To whom will the auditor speak to?
Answer: During the ISMS audit both internal and external (certification) auditor has the right to speak to anyone in the company, so he can speak to people from IT department, security department, to the CEO or to any business department.
The point of the audit is to find out whether the employees are complying to the policies and procedures, and these documents are not only applicable to security department.
Answer: ISO 27001 does not define any requirements for information security boards, this phrase is not even mentioned in the standard. If you wish, you can organize some kind of a body that will coordinate information security activities, but it is not mandatory, and you can organize its work any way you want.
Answer: Yes, ISO 27001 allows you to set the scope of your ISMS for only one part of your organization. However, this is not recommendable for smaller organizations (smaller than 100 employees) - this is because all parts of your organization that will be outside of the scope will be treated as an "outside world" which means you will need to protect the information within the ISMS scope from those departments which are outside of the scope.
However, many folks I work with often inquire about or request some form of attestation of compliance (e.g. not certification, but some form of attestation that they are compliant with the standard). My inquiry was more about that… Can anyone attest to 27001 compliance (internally or via a third party)? Perhaps a bit of a grey area…
Answer: Internal audit is mandatory according to ISO 27001, so this is something you must do - however this internal audit has no relevance for the outside world. For the third parties, only the ISO certificates issued by certification bodies are recognized.
I’m guessing in such cases it really boils down to the ‘opinion’ of the person / party providing the attestation and their willingness to stake their reputation on such a claim. Correct?
Answer: I would say this is primarily a question of credibility - if the "certificate" is issued by a company that has no license for performing the certification, who would trust them?
There is no particular part of the system that you have to be f ocusing on by default. You should pay special attention to the most complex processes and the ones in which the probability of spotting nonconformities is the highest.