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ISO 27001 Package of Documents

Please note that ISO 27001 does not require a Policy on Privacy and Protection, and such a policy is not included in the toolkit to not cause an overhead effort to maintain the ISMS.

For the Privacy Policy template, I suggest you take a look at these templates to see if they can fulfill your needs:

• Personal Data Protection Policy https://advisera.com/toolkit-documents/eu-gdpr/personal-data-protection-policy/
• Employee Personal Data Protection Policy https://advisera.com/toolkit-documents/eu-gdpr/employee-personal-data-protection-policy/
• Website Privacy Policy https://advisera.com/toolkit-documents/eu-gdpr/website-privacy-policy/

Regulatory Compliance QMS Program

In our ISO 13485 & MDR toolkit, we have a complete list of documents as well as the project plan for how to implement it. This toolkit is applicable to all classes of medical devices under the MDR. Although this toolkit is not directly applicable to PMA approval, certain documents can be used.

You can download the complete list of documents on the following link: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

More details regarding the differences and similarities between the US and EU markets are discussed in this article:

• FDA vs. EU MDR Technical Documentation Matrix https://info.advisera.com/13485academy/free-download/fda-vs-eu-mdr-technical-documentation-matrix

• Initial Risk Assessment Non-conformity

  Please note that, when performing risk assessment, if an assessed risk takes into account controls already in place at the time of the assessment, it is important to document this information so anyone who reads the assessment can have the same understanding (otherwise, other persons will interpret the assessment with incomplete information).

  In Conformio, for each risk entry, you have a comment field where you can add information about which controls were already in place at the time of the assessment. This is the justification for assessing the risk as low.

• ISO 27001 / ISO 22301 Tools for Consultants in German

  Please note that not all controls from ISO 27001 Annex A need to be documented according to the standard (and in our opinion, it would be an overhead to document each and every one of them in a small company), and some of the controls you mentioned are covered by documents in the toolkit. 

  Our toolkit is created specifically for smaller companies that want to implement ISO 27001 in a quick way, without unnecessary paperwork; for larger companies that require more documents, we recommend getting some other solution. 

  Controls covered by documents in the toolkit:
  A.5.1 Policies for Information Security – This control refers to all policies defined for the ISMS.

  A.5.2 Information security roles and responsibilities - roles and responsibilities are described in all policies and procedures included in the toolkit. 

  Controls that do not require documentation are as follows, and information about how they are implemented is included in the Statement of Applicability (which can be found in folder 07 Applicability of Controls):

  A.5.3 Segregation of duties

  A.5.6 Contact with special interest groups

  A.5.8 Information security in project management

  A.5.34 Privacy and protection of PII

  A.5.36 Compliance with policies, rules and standards for information security

  A.7.1 Physical security perimeters

  A.7.2 Physical entry

  A.7.4 Physical security monitoring

  A.7.5 Protection against physical and environmental threats

  A.7.8 Equipment siting and protection

  A.7.11 Supporting utilities

  A.7.12 Cabling security

  A.7.13 Equipment maintenance

   

• 22301 certification

  Since ISO 27001 and ISO 22301 share many requirements (e.g., document management, internal audit, management review, etc.), the effort to implement the specifics of ISO 22301 (i.e., mainly clauses 6 and 8) is roughly 30% of the cost of ISO 27001 implementation.

• Toolkit documents

  Please note that the information security roles and responsibilities are defined and allocated along all the templates in the toolkit.

  High-level roles and responsibilities are defined in the Information Security Policy, while specific ones are defined in specific policies and procedures.

  For example, you can find this type of structure in the Backup Policy:
  [job title] must perform backup copies at planned intervals.

  [job title] must test backup copies to ensure the backup was performed successfully.

  For further information, see this article on documenting roles and responsibilities according to ISO 27001. 

• Where is your Continual Improvement policy template?

  Please note that ISO 27001 does not prescribe any specific documentation for clause 10.1 Continual Improvement.

  Our ISO 27001 Documentation Toolkit covers all mandatory documents and some documents that are not mandatory. A Continual Improvement policy do not need to be documented according to the standard, and in our opinion it would be an overhead to document it in a small company. 

  Our toolkit is created specifically for smaller companies that want to implement ISO 27001 in a quick way, without unnecessary paperwork; for larger companies that require more documents we recommend getting some other solution.

  This article will also help you: List of mandatory documents required by ISO 27001 (2013 revision)

  Commitment to continual improvement is defined in the Information Security Policy, which can be found in folder 05 General Policies.

  Examples of how you can demonstrate continual improvement are:

  • decrease in the number of incidents and losses due to security incidents
  • changes in the ISMS to correct problems or take advantage of opportunities identified during the management review

  These articles will provide you with further explanation about continual improvement:
  - Why is management review important for ISO 27001 and ISO 22301?
  - Achieving continual improvement through the use of maturity models

• Exclusions of the ISMS scope

  You are basically right - if the HR department is outside of the ISMS scope, from the ISMS point of view it will have the same status as a third-party provider; of course, legally speaking, your HR department is not a third-party provider, but a organizational unit of your company.

  This article will provide you with further explanation about scope definition:
  • All you need to know about setting the ISO 27001 scope
  This tool can also help you:
  • Tool for defining the ISO 27001 ISMS scope

  • Procurement and ISO 9001

    To align procurement with ISO 9001:2015, organizations need to consider the following:

    • Supplier Selection: ISO 9001 emphasizes the importance of selecting and evaluating suppliers. When procuring goods and services, organizations should choose suppliers that meet quality and performance requirements.
    • Supplier Audits: Organizations can conduct supplier audits to ensure that suppliers are conforming to quality and performance requirements set by the organization.
    • Quality Requirements: When procuring products or services, organizations should clearly communicate their quality requirements to suppliers. This includes defining specifications, standards, and other quality-related criteria.
    • Control of Purchased Goods and Services: ISO 9001 requires organizations to have processes in place for the control of purchased goods and services. This includes inspection, verification, and validation of products or services received from suppliers to ensure they meet specified requirements.
    • Monitoring and Improvement: ISO 9001 mandates ongoing monitoring and improvement of the quality management system. This extends to the procurement process, where organizations should track supplier performance and take corrective actions when necessary.
    • Continuous Improvement: ISO 9001 promotes a culture of continuous improvement. Organizations should use data and feedback from the procurement process to identify areas for improvement, enhance supplier relationships, and ultimately enhance the quality of the products or services they deliver to customers. 

    You can find more information at the following link:

    • Purchasing in QMS - The Process & the Information Needed to Make it Work - https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/

    • Creating the Register of Legal, Contractual, and Other Requirements

      First is important to note that in this module, you need to list only the requirements of customers and regulators you need to comply with. Requirements related to suppliers are handled only in case there are risks that justify handling them.

      Considering that, you should list each regulation as a unique entry because they are typically related to a specific reference (e.g., data privacy in Europe refers to GDPR and in Brazil to LGPD).

      Regarding clients, you can group the clients with the same requirements together (e.g. if you have the same agreement signed with all of them), or you should list them separately if their security requirements are very different.

      Regarding the level of detail, you can include only a summary of the requirement and refer to another document where more detailed information can be found.