We have an internal audit procedure, which defines the auditor requirements, I.e. qualified, scope, criteria, plan, etc.
They said we need to audit them and document an audit report of the auditors, and we can even give them minor/major NCs.
Am I crazy?
Answer: ISO 27001 clause 9.2 (Internal audit) requires that an organization selects auditors and conducts audits that ensure objectivity and the impartiality of the audit process, and in the situation you mention it means the auditors cannot audit their own work. When you have more than one auditor, they can audit each others work. In cases were you only have one auditor, the organization must consider hiring an external auditor to audit specifically the clause 9.2.
Answer: There is no standard set of consequences if an ISO standard is not implemented in an organization, because these will depend on the applicable laws, contracts, regulations and business objectives, which will vary from organization to organization.
To help organizations understand this, ISO management standards require that organizations determine external and internal issues relevant to its purpose and that can affect its management system, including needs and expectations of interested parties (clauses 4.1 and 4.2 of ISO management standards).
On the other hand, when talking about benefits of adopting ISO standards, they can be related to:
- Enhanced competitive edge
- Reduction on losses due to incidents and non conformities
- Reduction on fines due to legal or contractual non conformity
- Improvement of internal organization
The EU GDPR will apply to the processing of personal data of EU data subjects, regardless of whether the processing activities take place in the EU or not. The EU GDPR is also applicable to entities established outside the EU if they offer goods or services to individuals in the Union, or if they monitor the behavior of individuals in the Union (i.e., profiling activities, tracking individuals’ activities on the internet, etc.)
The key to understanding when EU GDPR is applicable is understanding the meaning of “in the Union.” The EU GDPR will only apply to personal data regarding individuals within the Union, while the nationality or habitual residence of those individuals is irrelevant.
In your case, since the company is based in Brunei and the processing takes place in Brunei and the data subjects are ba sed in Brunei (regardless if they are UK citizens) the EU GDPR won`t be applicable.
The deidentification of data using a ID number or customer number is a measure to protect personal data which is caller “pseudonymization” which is referred to and recommended in article 32 of the EU GDPR – “Sec urity of processing” https://advisera.com/eugdpracademy/gdpr/security-of-processing/ so by all means proceed.
2) If personal data is transferred from India to one of the EU countries, then will it be considered as transfer to third country?
3) If we collect personal data from a site like ‘xxx’, will it be a joint controller for us?
4) In a case, where we are Processor, is Privacy Notice applicable?
Answer: The time to implement ISO 27001 will depend on many variables, like the size of the organization, the complexity of the scope, the resources available, etc., but in general, for small and medium-sized organizations the implementation duration, can vary from 10 to 12 months.
Regarding how many people should be included in the project, there is no definitive number you should consider (this number also depends on the complexity of the scope), but to increase chances of success, it is important that persons involved have experience in project management and knowledge of the standard.
Answer: ISO 27001 does not require development of a business case for ISMS implementation, although the elaboration of such material can be very useful to help you to identify business objectives related to information security and buy in the top management support for this project, and to define top-level objectives for the ISMS (which are mandatory for the standard).
1. Could you share any Case Study or role play exercises.
Answer: It's our policy not to provide specific answers or materials related to exams.
2. Is this session required technical skills such as the controls to answer correctly ?
Answer: For the Lead Auditor course and exam there is no need for deep knowledge about the controls to answer the questions, although basic knowledge will make easier for you to develop your answers.
3. Do we have to memorize the Annex A controls for the exam?
Answer: There is no need to memorize specific information for the exam (you can consult the standard during the exam), but it is important you understand and memorize the general structure of the standard, because this will let you find what you want faster (e.g., if the question is about leadership, then you can go directly to section 5 of the standard).
4. In the webinar, you mentioned that we should think of 5 to 6 findings. Do you mean we ju st arbitrarily think some security findings or there will be a case study to ask you for any security findings and describe the non-conformities?
Answer: In the exam there will be case studies for you to read and evaluate if they contain or not non-conformities (5 to 6 findings are the general quantity you can expect). You should note that not all case studies will contain non conformities (one of the purposes of the exam is just this, evaluate your understanding and skill to identify situations that are non conformites and when they are not).
5. Lastly, do we have to study the ISMS Manual in the exam ?
Answer: ISO 27001 does not require an ISMS Manual, so this document will not be covered in the exam.
2) in one trial CRO where I'm working is responsible for Data Management - so here it's clear for me that we are data processor. But I have other trial where the DM is done by third party, but we are checking at the sites patient's data against CRF data - does it mean that here we are also data processor ? it's not clear for me..in this situation..
3) is there any situation where CRO might have the status of joint data controller ? or CRO is always the data processor, even if not responsible for the data management?
Answers:
The DPO contact details should be provided to the patient when the patient consents to the trial and is presented with the Privacy Notice. Don`t forget that the EU GDPR requires that the consent needs to be informed so the consent for shoul d always be paired with the Privacy Notice.
If the processing you do is based on the instructions of the DM then you are a processor. If you however do the processing based on your own judgement then you are a controller regardless if you receive the personal data from a third party.
If the CRO decides the scope and means of processing together with another party then we can assume that joint processing. Each situation needs to be assessed in order to establish the controller, processor, joint controller status.
You should not assume that you are either until you have assessed the particular situation.