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Procesos externalizados
Mi respuesta:
La subcontratación de un proceso que necesita la organización está sujeto a los requisitos de las cláusulas 8.4 (Control de proveedores externos) y la cláusula 4.4 (SGC y sus procesos) de la norma ISO 9001:2015.
Hay que asegurarse de incluir todos los procesos externalizados que afectan a la calidad del producto o servicio en el alcance del SGC, en este caso la empresa que realiza el proceso de selección de los empleados. Es necesario identificar, definir y demostrar evidencia de controles suficientes sobre el proveedor externo del proceso externalizado para asegurar que tal proceso es llevado a cabo según los requisitos de I SO 9001:2015. La naturaleza y alcance de tales controles van a depender de la naturaleza del proceso externalizado o subcontratado y el riesgo que ello implica. Los procesos externalizados pueden ser controlados de muchas maneras, por ejemplo, facilitando especificaciones del servicio o el manual de calidad de proveedores que deben de cumplir; pidiéndoles resultados de inspecciones o certificados de conformidad, o la validación del proceso externalizado; realizando auditorias del servicio y auditorias del SGC del subcontratista; etc.
Para más información, puede leer el artículo"Cómo controlar procesos subcontratados utilizando la ISO 9001" (en inglés): https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/
Los siguientes materiales le ayudarán con los sistemas de gestión ISO:
- Libro “Preparación para el proyecto de implementación ISO: una guía en un lenguaje sencillo”: https://advisera.com/books/preparacion-para-el-proyecto-de-implementacion-iso-una-guia-en-un-lenguaje-sencillo/
- Capacitación gratuita en línea: “Curso de fundamentos ISO 9001”: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
- Conformio (herramienta en línea para ISO 9001): : https://advisera.com/conformio/ -
Inventory of assets
Answer: I saw that you covered assets most related to hardware and information media. Considering the ISO 27005 standard (information security risk management), annex B (identification and valuation of assets and impact evaluation), I think you should also consider the following for assets that will need some sort of control that will be relevant for every employee:
- Specific types of information (e.g., those with high cost to produce or replace, those related to business strategy and performance, people's privacy, etc.)
- People in specific positions (e.g., decision makers, key department managers, developers, products/processes specialists, etc.)
In the Inventory of Assets template that comes with your toolkit you have a list of assets you can consider (sheet "Checklist of assets").
If you still have any doubts, included in your toolkit you can schedule a meeting with one of our experts so he can provide you additional support. To schedule a meeting you can access this link: https://advisera.com/27001academy/consultation/ -
Defining the scope of internal laboratory
Answer:
The level of details to be included in the lab scope will depend on the complexity of the measurements your lab performs. If you have fairly liberal tolerances, you can afford to generalize where others may not be able to. The topics that are usually included in the lab scope are laboratory testing and calibration methods, equipment listing, methods and standards. -
Closing meeting for internal audit
Answer:
Closing meeting is not required by the standard for internal audits and most companies don't hold it although I think it is a good idea. On the closing meeting you should present to the top management the results of the internal audit.
You can start with explaining the scope of the audit, the audit criteria, whether the audit plan was fully realized ( for example, you can tell them if there were some processes or locations that were left out from the audit and present the reasons why) and then you can present them with the audit findings (nonconformities, recommendations for improvement, etc).
For more information, see: ISO 9001 – How to prepare for an internal audit https://advisera.com/9001academy/blog/2017/09/26/iso-9001-how-to-prepare-for-an-internal-audit/
These materials will also help you regarding internal audit:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free onli ne training ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
ISO 9001 vs IATF 16949 transition
Answer:
If you are planning to let go of IATF 16949 and want to keep only ISO 9001 certificate, then you do not have to include APQP. On the other hand, APQP is in most cases the customer requirement, so if the customer requires it, you should keep it regardless of whether you keep IATF 16949 certificate or not.
For more information, see: Establishing Advanced Product Quality Planning (APQP) in IATF 16949 https://advisera.com/16949academy/blog/2017/09/13/establishing-advanced-product-quality-planning-apqp-in-iatf-16949/ -
Documenting context of the organization
Answer:
ISO 14001 does not require context of the organization (internal and external issues) to be documented. However, if you decide to document them you can do it through some kind of record, it can be a sheet or record from the meeting on which the organization determined the context. This document can be kept separately, or can be an appendix to the manual, the document about the scope, etc.
For more information, see: Determining the context of the organization in ISO 14001 https://advisera.com/14001academy/knowledgebase/determining-the-context-of-the-organization-in-iso-14001/
These materials will also help you regarding the documentation and the context:
- Book Managing ISO Documentation: A Plain English Guide https://advisera.com/books/iso-standard/iso-14001/
- Free online training ISO 14001:201 5 Foundations Course https://advisera.com/training/iso-14001-internal-auditor-course/
- Conformio (online tool for ISO 14001) https://advisera.com/conformio/ -
Who must perform the Risk Assessment within the Company?
The risk assessment must be performed by all organization units involved with the ISMS scope (good practice would be the risk assessment being performed by one person from each department), either all together in a single process or in separated processes that will be consolidated later (this will depend on the size of the scope, its complexity, number of people involved, etc.). Regardless of the approach, you should consider the participation of the Information Security Manager, or someone with knowledge on the risk assessment process, to act as facilitator, supporting the organization units personnel to identify, analyse and evaluate the risks concerning their activities.
This article will provide you further explanation about the risk assessment process:
- ISO 27001 risk assessment & treatment – 6 basic steps https://advisera.com/27001academy/knowledgebase/iso-27001-risk-assessment-treatment-6-basic-steps/
These materials will also help you regarding the risk assessment process:
- Book ISO 27001 Risk Management in Plain English https://advisera.com/books/iso-27001-risk-management-in-plain-english/
- The basics of risk assessment and treatment according to ISO 27001 [free webinar on demand] https://advisera.com/27001academy/webinar/basics-risk-assessment-treatment-according-iso-27001-free-webinar-demand/ -
Required documentation vs documented process
Answer:
The standard does not use the term "required documentation" and it can refer to all documents and records required by the standard. The term "required documented process" refers to mandatory documented procedures required by the standard.
Besides the term "documented process", IATF 16949 uses the term "documented information", the same as ISO 9001. There are two phrases where this term is used and they mean different kind of documented information. The first is "maintain documented information" and this refers to different documents such as Quality Policy and QUality Objectives and the second is "retain documented information as an evidence" which means that you need to produce some kind of record, for example record of risk analysis.
For more information, see: How to structure IATF 16949:2016 documentation https://advisera.com/16949academy/knowledgebase/how-to-structure-iatf-16949-2016-documentation/ -
ISO 27k project sponsor
Answer: Generally a project manager has to report to the project sponsor, the person who has the most interest in the project success and the authority to make things happen if the project is not going well. In some cases this person is the CEO or a member of top management, but since you stated that an information security manager is already designated, then you should verify in the project plan documentation who is the project sponsor.
This material will also help you regarding ISO 27001 project implementation:
- Preparations for the ISO Implementation Project: A Plain English Guide https://advisera.com/books/preparations-for-the-iso-implementation-project-a-plain-english-guide/ -
Asset inventory content
Answer: In the inventory of assets you should list anything inside the ISMS's scope that has value to the organization, generally grouping them in terms of processes, information and resources that support them (e.g., hardware, software, network, etc.). To avoid excessive, and sometimes unnecessary effort, if there is no specific reason to list an individual asset separately (e.g., the information on a employee's laptop), you can refer to them as general asset in your inventory (e.g., HR laptop, or corporate laptop, etc.). Regarding additional information, besides the identification o f the asset's owner, an organization is free to decide which information to include that in its evaluation will make the asset management easier (e.g., software version, asset's physical location, etc.).
This article will provide you further explanation about asset management:
- How to handle Asset register (Asset inventory) according to ISO 27001 https://advisera.com/27001academy/knowledgebase/how-to-handle-asset-register-asset-inventory-according-to-iso-27001/
These materials will also help you regarding asset management:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/