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You need to clearly state both companies in the ISMS scope statement. Affiliated companies are not automatically included in any ISO management systems scopes.
This article will provide you a further explanation about scope definition:
An item in the List of requirements needs to be specified at a level where the person responsible for its fulfillment understands what is needed to be done.
For example, for some persons you may need to specify only the name of the regulation (e.g., EU GDPR) or contract number, while for others you may need to be more specific, referring to specific clauses (like your example), or even writing them in the register.
This article will provide you a further explanation about requirements:
The new version of ISO 27002 will probably be released this year (its FDIS - Final Draft International Standard - is already published).
For further information, see:
Please note that such templates are not mandatory for ISO 27001 neither they are commonly adopted by organizations in general.
The closest templates we can suggest you check to see if they can fulfill your needs are these ISO 9001 templates:
For further information, see:
1. How would we know what regulation is applicable if they have never stated?
If you are on the EU market, then each manufacturer of a medical device or its components must be in compliance with Harmonised or state of the art standards (Article 8 of the Medical device regulation MDR 2017/745).
Those standards you can find on the following links:
Basically, besides ISO 13485:2016, all manufacturers must also be in compliance with ISO 14971:2019 (Risk management for medical devices), EN ISO 15223-1:2021 (for symbols), and EN ISO 20417:2021 - Information to be supplied by the manufacturer. Is there any other technical standard it would depend on the type of components: is it metal, is it plastic, or something else.
For more information, see:
2. Can the toolkit ISO 13485:2016 be combined with the ISO 9001:2015?
Yes, it can, several requirements are very similar like internal audit process, corrective actions management, non-conformity process, and document management. At the end of the standard ISO 13485:2016 you have Table B1 Correspondence between ISO 13485:2016 and ISO 9001:2015, and Table B2 Correspondence between ISO 9001:2015 and ISO 13485:2016, therefore from both sides.
3. We don’t have to report to the authorities if we have a customer complaint. How would we right this in our procedure or would we leave this alone? Would we use the form also and if so how would we use this?
This just depends on whether or not your product is registered somewhere as a medical device separately. If not, then you do not have to communicate with regulators.
Implementing ISO 27001 and ISO 22301 considering only internal needs is acceptable for certification purposes. In this case, the “customers” can be some of the organization’s own internal departments (e.g., Projects department as a customer of IT department, Accounting department as a customer of the Sales department, etc.).
Later, when and if you identify the need, you can expand the certification scope to cover the organization’s Customer’s security and Service availability requirements.
These articles will provide you a further explanation about the scoped definition and interested parties:
1. Seems like you are informing me through Conformio that I should prepare Policies with Annex A controls to incorporate into them (as seems in Project Plan). In example Title : Incident Response Policy, we will mention the annex A controls in it. Shouldn't we just have a folder A.16 Incident Security Incident Management and files A.16.1 Responsibilities, A.16.1.2 Reporting Information Security Events, A.16.1.3 Reporting Information Security Weaknesses, A .16.1.4 Assessment of and Decision on Information Security Events, etc.?
Please note that organizing documents as you suggest only makes them more difficult to read and maintain.
Considering your example, instead of a single document defining how incident management is implemented you would have to keep seven independent documents.
Additionally, when you have a document that refers to controls from different sections (e.g., the Supplier Security Policy refers to controls from sections A.7, A.8., A.14, and A.15), reading and maintenance become even more difficult.
For further information, see:
2. Is there a Tool JUST on Risk Assessment?
To perform just risk assessment we have the Risk Assessment Toolkit (https://advisera.com/27001academy/iso-27001-22301-risk-assessment-toolkit/) which comprises of the following documents:
This article will provide you a further explanation about risk assessment:
These materials will also help you regarding risk assessment:
1 - Do you have a presentation that shares some insight on the opposite route - Using ISO 27001 for implementing ISO 9001?
These materials can give you the insights you are looking for:
2 - And would there be any value in going down that route, given our customers do not normally require ISO 9001?
Please note that besides benefits for the customer (which are the main drive for ISO 9001), the organization itself can benefit from implementing ISO 9001:
So, even if customers do not require it, implementing ISO 9001 can bring value to the organization.
For further information, see:
1 - Here is the practice I've found (part 1) : After reading one of your article (https://advisera.com/27001academy/blog/2013/06/18/one-information-security-policy-or-several-policies/) I found that I just had to cut thinks in smaller pieces. Your article is also a nice argument since the architect manager had told me he prefers bible documents, and my manager doesn't like the idea at all. That article really is a great help for me. Thanks for writing it. You're the only expert to provide such information on policies organization. After reading an article from another expert I've also decided to cut the documents per Management System and to respect an integration logic. Here are the systems to integrate at the document level I've already listed : QMS, SMS, ISMS, PMS, UMS, CMS, OHSMS, FSMS, EMS. I hope this is the good logic since your article is not covering the integration aspect of policy management. What's your opinion ?
Your logic is sound because you are separating the systems according to their core processes.
Regarding integration of policy management, ISO management systems have a lot of requirements in common, which allow using single documents with minor adjustments to cover core issues from several management systems (e.g., document and record control, internal audit, management review, corrective actions, etc.).
For further information, see:
Here is where I'm stuck : For the moment I've found that documents storage should be organized with a classification plan that should reflect the processes logic. It sounds quite reasonable even if it is hard to visualize a SharePoint site design per processes. I've also found that policies are produced by pilot processes. So OK but policies are also used by operational managers as entry points when designing their own processes. From that on I'm stuck. How do classification plans manage the documents that are shared between processes owners ? I've not been able to find example of IT documentation storage yet to help me find the answer to that question or to find out if the "process logic" was the correct goal for IT processes document classification. Is there something about classification plans of processes documents in security standards ? Can you give me hints or advice so I can start writing a classification plan that can be used by SharePoint experts to build a nice & secured documentation site to host the old documents and the new policies ? Thanks.
If I understood correctly, you are asking about access control management. ISO 27001 does not prescribe how to do that, only main guidelines on what you need to achieve, so you can use any logic that fits the organization's needs.
Considering that, to build the structure you need to allow people to have access only to the documents they need to do their work, you should consider developing access control profiles according to required needs. In this case, you should:
As for roles/persons you can have, for example, developers, managers, architects, a specific person, etc. As for access rights you can have, for example, read access and edit access.
As for the idea of “process logic”, you can use them as a base for your profiles. Something like:
Since you’ve mentioned international access, you can further detail profiles by classifying them according to countries (e.g., Operational processes – step n – country m)
To see how this can be defined in terms of a policy, please take a look at this template: https://advisera.com/27001academy/documentation/access-control-policy/
For further information, see:
1.Can DPO have another role in the company except this one?
Yes, as long as the role is not in a conflict of interest with the DPO role. Namely, the DPO shouldn’t approve his or her own processing operations. The DPO cannot be someone from marketing, or from sales, or from operations, or from legal department and so on. This is mentioned in article 38 – Position of the data protection officer – in GDPR, paragraph 6: “such tasks and duties do not result in a conflict of interests”.
2.Can a DPO be an external consultant/contactor
Yes. Article 37 - Designation of the data protection officer – paragraph 6 mentions that “The data protection officer may be a staff member of the controller or processor, or fulfil the tasks on the basis of a service contract.”
You can find more details at these links: