First step is for you to decide which path you want to follow among these general fields: security management, security assurance (i.e., security audit), or technical security, and this last one has many sub fields (e.g., software development, security operation, etc.). Once you has decided this path there are many certifications available for each field (e.g., CISM for security management, CISA for security assurance, and CISSP for overall technical security).
Considering specifically ISO 27001 career you can follow:
- ISO 27001 Lead Implementer – this certification recognizes people who have competency on the ISO 27001 implementation process.
- ISO 27001 Lead Auditor – this certification recognizes people who have competency on auditing an ISM S against ISO 27001 requirements and want to become certification auditors (and with this provides more confidence to an organization for being certified).
May I ask which country can accept ISO 13485 and ISO 9001?
Answer:
ISO 13485 is accepted worldwide as a benchmark for Quality Management System evaluation for medical equipment. In specific, countries in Asia and the US are also adopting the ISO 13485 standards as part of their regulatory requirements.
Controlling documents after implementation
Answer:
My interpretation of your question is: How can someone ensure that after implementation documents are not changed by users without authority to change them?
I see several approaches being used by organizations:
* Only digital versions are considered as valid. People access documentation through smartphones, tablets, terminals or computers, and documentation is protected from changes. And when someone prints a document a watermark appears saying that the organization does not control printed copies;
* Any printed version is only valid if signed by the authorized issuer;
* Frequent internal audits ensure that document control is learned and practiced
Answer:
As you have indicated, different types of documented information require different retention times, and these will come from different places. Unfortunately, these places are not the same for every industry in every country in the world. For instance, in Canada we need to keep financial records for 7 years, but this will be different in other countries, and different laws will apply to this.
However, in general the record retention times for production records will come from customer requirements, even if there is a legal requirement associated with them. For instance, for aircraft records in North America there is a legal requirement to keep records for the life of the aircraft, but this should be flowed down to suppliers through contracts stating how long records are to be kept, and what to do at the end of this time (such as forwarding the records to the customer). For non-aircraft aerospace suppliers, the cust omer requirements is also the place where customers indicate how long then need you to keep production records. If there is nothing there, then you need to determine a reasonable time-frame yourself.
For more on the requirements around document and record control, see this article: A new approach to document and record control in AS9100, https://advisera.com/9100academy/knowledgebase/new-approach-to-document-and-record-control-in-as9100/
ISO 9001:2015 and employee performance appraisals
love it
Is ISO 13485 required if we manufacture non-medical parts?
Answer:
ISO 13485 applies to all companies dealing with medical devices. Since in your case, you have clarified that the plastic part is not part of the medical device, ISO 13485 will not be applicable to you. However , you will still need to maintain the specifications and technical details about the part that you are manufacturing for the medical device manufacturer. Since you are currently certified to ISO 9001, it will be quite easy for you to adapt to ISO 13485 which will give you more advantage with your medical device clients in the future.
1. Regarding Inventory of assets: Which assets must be documented? In the tab "Type of Asset" I see a very long list and I think it's not achievable to document all the risks for all these assets, hence the question.
Answer: First it is important to note that you do not need to use all assets listed on the "Type of Asset" tab, they are only suggestions to help you identify which risks are relevant to your organization (the risks that quickly come to your mind). Considering the asset-threat-vulnerability approach for risk assessment this is quite straightforward (from that list you pick the most common and important assets you have, and from them you identify related threats and vulnerabilities).
2. Let us say a control is neither relevant for our company or mandatory for ISO 27001, would I be allowed to write at justification for non-selection that it isn't mandatory for us / ISO 27001?
Answer: A more robust justification for excluding a control would be "There are no unacceptable risks, or legal requirements that demand the implementation of this control", because this one makes explicit the main reasons not to implement a control.
3. Regarding the video tutorial 'How to Write Statement of Applicability' at minute +- 13:45: You're speaking about two mandatory documents, are these by default in the Statement of Applicability template? If that's not the case, in which document can I find these?
Answer: I'm understanding that you are referring to approval of residual risks and the approval for the ISMS implementation. As explained in the tutorial the approval of residual risks is included in the SoA. The record of the approval for the ISMS implementation is done through the Risk Assessment and Treatment Report, located on folder 05 Risk Assessment and Risk Treatment Methodology in your toolkit.
4. In case you're a Web hosting company, the Secure Development Policy isn't mandatory, right? If that is the case, is there anything specific that must be written, or is something similar to this alright: "This Policy is mandatory for ISO 27001, however this is not applicable in our business due to not developing software" ?
Answer: First it is important to note that in the Statement of Applicability the justification refers to controls, not documents. Documents are listed on implementation method, if a control is applicable.
Controls from ISO 27001 Annex A are mandatory only if:
- There are risks identified as unacceptable in the risk assessment that require the implementation of such controls
- There are legal requirements (e.g., contracts, laws, and regulations) that require the implementation of such controls
- There is a top management decision requiring the implementation of such controls
If none of these options occur there is no need to implement such controls, or documents which cover them. In you case you can use the same justification from answer 1 ("There are no unacceptable risks, or legal requirements that demands the implementation of this control")
5. Where could I document all the non-employees of the company in the ISMS Scope Document (apparently they have to sign the 'Statement of Acceptance of ISMS Documents'), do I just document them at 5.2 Organizational units?
Answer: The need for them to sign the 'Statement of Acceptance of ISMS Documents' does not mean they have to be part of the ISMS scope, only that they have to be aware of this document.
Non-employees which are related to processes, services, organizational units, locations, or IT infrastructure inside the scope are normally handled through clauses on contracts and service agreements.
Approaching a case - legal, policy and environmental assessment
QUESTIONS
1. Give the specific legal and policy provisions as per ISO 14000 environmental management framework for this project?”
Answer:
If the proposed location of the construction of the plant is a forest reserve area, then the specific legal provisions have to be directly negotiated with government and/or local authorities because that kind of organization is not easily compatible with a forest reserve area. Due to the planned location, policy should set guidelines around: “scenic areas, water sources, and ecologically sensitive areas within the radius of the project area”
“2. Give a detailed account on how you will carry out an environmental impact assessment?”
Answer:
I cannot give a detailed account of this space. However, I invite you to check these links: