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ISMS Controls

1 - I would like to know more about the Controls, are there any categories for controls ??

The 114 controls from ISO 27001 Annex A are organized into 14 sections (domains):

• A.5 Information security policies – controls on how the policies are written and reviewed
• A.6 Organization of information security – controls on how the responsibilities are assigned; also includes the controls for mobile devices and teleworking
• A.7 Human resources security – controls prior to employment, during, and after the employment
• A.8 Asset management – controls related to inventory of assets and acceptable use; also for information classification and media handling
• A.9 Access control – controls for the management of access rights of users, systems, and applications, and for the management of user responsibilities
• A.10 Cryptography – controls related to encryption and key management
• A.11 Physical and environmental security – controls defining secure areas, entry controls, protection against threats, equipment security, secure disposal, Clear Desk, and Clear Screen Policy, etc.
• A.12 Operational security – lots of controls related to the management of IT production: change management, capacity management, malware, backup, logging, monitoring, installation, vulnerabilities, etc.
• A.13 Communications security – controls related to network security, segregation, network services, transfer of information, messaging, etc.
• A.14 System acquisition, development, and maintenance – controls defining security requirements, and security in development and support processes
• A.15 Supplier relationships – controls on what to include in agreements, and how to monitor the suppliers
• A.16 Information security incident management – controls for reporting events and weaknesses, defining responsibilities, response procedures, and collection of evidence
• A.17 Information security aspects of business continuity management – control requiring the planning of business continuity, procedures, verification and reviewing, and IT redundancy
• A.18 Compliance – controls requiring the identification of applicable laws and regulations, intellectual property protection, personal data protection, and reviews of information security

For further information, see:

• A quick guide to ISO 27001 controls from Annex A https://advisera.com/27001academy/iso-27001-controls/

This material also can help you:

• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/

2 - Important controls / not so important controls ??

Please note that controls' importance will depend on the results of risk assessment and applicable legal requirements, so before getting this information you should avoid trying to give some importance degree to controls, because you risk super estimating or underestimating controls, and this can negatively impact your risk management process.

This article will provide you a further explanation about selecting controls:

• The basic logic of ISO 27001: How does information security work? https://advisera.com/27001academy/knowledgebase/the-basic-logic-of-iso-27001-how-does-information-security-work/

This material will also help you regarding risk management:

• Book ISO 27001 Risk Management in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/

Business abiding by ISO 27001 when using BYOD policy

First of all, you have to perform a risk assessment to identify which risks related to BYOD practice you have to treat, and which legal requirements (e.g., clauses of contracts, laws, or regulations) you have to fulfill. After that, you have to identify proper controls to be implemented. In general, to secure BYOD practices you have to consider the following controls:

• A.6.2.1 Mobile device policy
• A.6.2.2 Teleworking
• A.13.2.1 Information transfer policies and procedures
• A.13.2.3 Electronic messaging

Normally, these are implemented through a BYOD policy, which you can see how it looks like at this link: https://advisera.com/27001academy/documentation/bring-your-own-device-byod-policy/

This article will provide you a further explanation about BYOD policy:

• How to write an easy-to-use BYOD policy compliant with ISO 27001 https://advisera.com/27001academy/blog/2015/09/07/how-to-write-an-easy-to-use-byod-policy-compliant-with-iso-27001/

These materials will also help you regarding BYOD policy and for training and awareness:

• ISO 27001 Annex A Controls in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/
• Free Security Awareness Training: https://advisera.com/training/awareness-session/security-awareness-training/ - this is a series of 25 videos that cover various topics related to security.

Fulfilling documentation requirements of ISO 13485 and MDR in Quality Management System and demonstrating it in matrix

MDR requires manufacturers to have implemented a quality management system. Requirements regarding the quality management system are stated in Article 10, clause 9. All requirements from the ISO 13485 are in that clause. However, there are some additional requirements like the requirement to document strategy for regulatory compliance, to document the process of issuing UDI number, and fulfillment of the General safety and performance requirements.

Therefore, if you have prepared the QMS according to the ISO 13485, all you have to do is:

• to prepare those additional requirements and put them on the list of documents
• to define who is responsible for performing those processes.

For more information, see:

• EU MDR Article 10 https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

• ISO 13485 & MDR Integrated Documentation Toolkit https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

Following link regarding the documentation requirements for both ISO 13485 and MDR can be helpful:

• EU MDR Checklist of Mandatory Documents https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents

Electronic File/Folder structure SOP

ISO 27001, like other ISO management standards, has requirements for document and records management you can use to define how to create, approve, review, distribute, and communicate them, among other things.

Considering electronic documents and records, if the quantity of them is not so big you can consider organizing them in folders identified by each section of the standard which requires them (e.g., in folder named "Information Security Policy" you can store the Information security policy, in folder "Risk assessment and Treatment" you can store documents and records related to the risk management process, etc.)

If the quantity of documents is big, you should consider a document management solution (you can see an example of such solution in our platform Conformio at this link: https://advisera.com/conformio/)

For physical records, you should consider a central cabinet to store them, adopting a folder structure similar to the electronic documents.

To see how a procedure to control documents and records compliant with ISO 27001, please take a look at the free demo of this template: https://advisera.com/27001academy/documentation/procedure-for-document-and-record-control/

These articles will provide you a further explanation about document and record management:
- Document management in ISO 27001 & BS 25999-2 https://advisera.com/27001academy/blog/2010/03/30/document-management-within-iso-27001-bs-25999-2/
- Records management in ISO 27001 and ISO 22301 https://advisera.com/27001academy/blog/2014/11/24/records-management-in-iso-27001-and-iso-22301/

These materials will also help you regarding document and record management:
- Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/
- Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

ISO 9001 Warehouses

ISO 9001:2015 is not about departments but about processes.

What kind of processes happen at a warehouse?

• Reception of materials and goods
• Expedition of materials and goods 

Reception starts with quality control, then identification, then storage, then supply to production.

Expedition may start with quality control, then identification, then packaging, then storage, then expedition.

Clauses related with that can be:

• 6.1 risks about can happen in the warehouse
• 7.1.3 maintenance of hardware, software, communications, facilities and transport
• 7.1.4 relevant requirements about the work environment
• 7.2 people working at the warehouse is competent
• 8.4 purchasing information, quality control requirements
• 8.5.2 identification and traceability
• 8.5.3 property belonging to clients and external providers
• 8.5.4 preservation
• 8.6 quality control
• 8.7 treating nonconformities 

You can find more information below:

• How ISO 9001 improves shipping procedures - https://advisera.com/9001academy/blog/2019/07/09/how-iso-9001-improves-shipping-procedures/
• Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

ISO 9001 Risk Assessment

ISO 9001:2015 has no mandatory requirements concerning risks and opportunities – please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ . So, whatever the method used by your organization to document and evaluate your risk assessment is valid if it suits your needs. Without knowing your particular approach is very difficult to help you.

You can find more information below:

• How to address risks and opportunities in ISO 9001:  https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
• How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
• For a free preview of an example of the Registry of Key Risks and Opportunities - https://advisera.com/9001academy/documentation/registry-of-key-risks-and-opportunities/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Internal Auditor from outside

Please note that ISO 27001 does not require the internal audit procedure to be documented, but it requires the internal auditor program and audit results to be documented, so your hired internal auditor needs to provide at least the internal auditor program and the Audit report.

This article will provide you a further explanation about mandatory documents:
- List of mandatory documents required by ISO 27001 (2013 revision) https://advisera.com/27001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-27001-2013-revision/

This material will also help you regarding internal audit:
- ISO Internal Audit: A Plain English Guide https://advisera.com/books/iso-internal-audit-plain-english-guide/
- ISO 27001:2013 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/

Questions for ISO 27001 & 22301 List of Mandatory Documents

For questions 1 to 4, and 6 to 7, please note that there are no clauses in the Standard, nor controls from Annex A, requiring these procedures and policies to be documented, but the related annexes are mandatory because at least one of the related clauses or controls requires the information they contain to be recorded, providing evidence that these clauses and controls are implemented. Related policies and procedures are included in the toolkit because they are commonly implemented as good practice.

Regarding question 5, you are correct, and we apologize for this mistake. The reference must be indeed A.16.1.2, nor A.6.1.2.

For further information about mandatory documents, please read:

• List of mandatory documents required by ISO 27001 (2013 revision) https://advisera.com/27001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-27001-2013-revision/

DRP aplicabilidade

Controles não implementados informados conforme aplicáveis na Declaração de Aplicabilidade podem de fato levar a uma não conformidade, mas seu grau dependerá de outros fatores, tais como se eles estão relacionados a riscos relevantes, ou fazem com que uma cláusula obrigatória da norma não seja cumprida.

Nas situações quando um controle ainda não se encontrará implementado no momento da auditoria de certificação, a melhor alternativa é aceitar os riscos relacionados a este controle, informar na Declaração de Aplicabilidade que o controle se encontra em situação de implementação e apresentar ao auditor as evidências do andamento da implementação.

Desta forma a situação de implementação não pode ser caracterizada como uma não conformidade.

Estes artigos podem prover mais informações:

• Which questions will the ISO 27001 certification auditor ask? https://advisera.com/27001academy/blog/2015/07/20/which-questions-will-the-iso-27001-certification-auditor-ask/
• Infographic: The brain of an ISO auditor – What to expect at a certification audit https://advisera.com/articles/infographic-the-brain-of-an-iso-auditor-what-to-expect-at-a-certification-audit/

Este material também pode prover mais informações:

• ISO 27001/ISO 22301: The certification process [free webinar on demand] https://advisera.com/27001academy/webinar/iso-27001iso-22301-certification-process-free-webinar-demand/

DRP applicability

Unimplemented controls reported as applicable in the Applicability Statement may in fact lead to non-compliance, but their degree will depend on other factors, such as whether they are related to relevant risks, or cause a mandatory clause of the standard to be breached.

In situations when a control is not yet implemented by the time of the certification audit, the best alternative to avoid a nonconformity is to accept the risks related to this control, inform in the Statement of Applicability (SoA) that the control is in an implementation situation, and present to the auditor the evidence of progress in implementation.

This way, the implementation situation cannot be characterized as a non-conformity.

These articles can provide more information:

• Which questions will the ISO 27001 certification auditor ask? https://advisera.com/27001academy/blog/2015/07/20/which-questions-will-the-iso-27001-certification-auditor-ask/
• Infographic: The brain of an ISO auditor - What to expect at a certification audit https://advisera.com/articles/infographic-the-brain-of-an-iso-auditor-what-to-expect-at-a-certification-audit/.

This material can also provide more information:

• ISO 27001 / ISO 22301: The certification process [free webinar on demand] https://advisera.com/27001academy/webinar/iso-27001iso-22301-certification-process-free-webinar-demand/