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Quality Reports
Answer:
I'm not sure what you mean by Quality Reports and what is the content of this record, but according to clause 8.6 in ISO 9001:2015 that defines requirements for production process, the organization must maintain the following documented information:
- characteristics of the product to be produced or service to be provided
- records about customer property
- production/service provision change control records
If the Quality Report serves to meet one or more of the above mentioned requirements, than it is mandatory to have it. On the other hand, if it is used to monitor or measure some of the parameters in the production process and it is mentioned in the production procedure, than it can also be considered as a mandatory document.
For more information, see: List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/it/knowledgebase/le-cinque-fasi-principali-della-verifica-interna-iso-9001/ ist-of-mandatory-documents-required-by-iso-90012015/
These materials will also help you regarding mandatory documentation:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Definition of security roles and responsibilities
Answer: ISO 27001 does not require to write a separate document for roles and responsibilities, that's why there is no specific template in the toolkit defining roles and responsibilities
Besides the general roles and responsibilities defined in the Information Security Policy template, all other detailed responsibilities are defined in each template every time an specific activity is required to be performed. Every time you find the field "[job title]" in a template this means that you have to define who has the responsibility to perform the activity described in the sentence. For example, in the sentence:
"[job title] must document the following in the Statement of Applicability: ...", you have to define which role in your organization has the r esponsibility to fill the Statement of Applicability.
This article will provide you further explanation about roles and responsibilities:
- How to document roles and responsibilities according to ISO 27001 https://advisera.com/27001academy/blog/2016/06/20/how-to-document-roles-and-responsibilities-according-to-iso-27001/
By the way, with the toolkit you bought you also have the access to video tutorial that can help you fill your documentation. You can find these tutorials in Conformio, it the menu "Repository", in folder "Video tutorials" - see what you need to click here: https://www.screencast.com/t/T5rLxMgc3UJz -
SoA update
Answer: Yes. The SoA is a living document that must be updated as required to reflect the organization's approach towards information security, but you have to ensure that any modification to the SoA is justified and formally approved and recorded as defined in your document control procedure.
This material will also help you regarding documentation control:
- Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/ -
Control of changes
Answer:
When it comes to changes in documentation, you should follow your existing procedure for document and record control. The changes you are mentioning are related to the clause 6.3 Planning of changes which refers to changes in the processes and the QMS. This clause doesn't required documented information, but it would be beneficial if you would describe in the manual how the changes in the QMS are planned and executed, but you don't have to develop any form and even if you decide to develop it, it doesn't have to cover all requirements of the clause.
For more information, see: QMS Change Management in 7 steps https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/
These materials will also help you regarding planning changes:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Defining responsibilities for ISO 9001 requirements
To be somewhat clear, every other departments (not the HR) of an organization has employees under its control. On the issue of competence Clause 7.2 of the standards it requires to retain documented information as evidence. of competence. Somebody says, I could not make that a part of my audit question since it should be the HR department who must be audited on that matter."
Answer:
There are some requirements that are specific for some processes, like clause 8.5 fro production process, or clause 8.4 for purchasing process. However, there are also requirements that should be applied throughout entire QMS (Quality Management System) such as requirements for control of documented information.
Requirements for competence can be met in different ways in different companies, for example, you can have an HR department that is responsible for the requirements (and this is more common or you can have these requirements met on the level of each department or process. Depending on who is responsible for keeping the records about the competence, you need to required them from appropriate person. If the organization has HR department, they are probably in charge of the competence records.
For more information, see: How to ensure competence and awareness in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-ensure-competence-and-awareness-in-iso-90012015/
These materials will also help you regarding the audit:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online 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/ -
Documenting finance and accounting process
Answer:
Since the standard doesn't have any requirements regarding finance and accounting processes, you don't have to document them or even include them in the scope of your QMS (Quality Management System). It is enough to identify them as a supporting processes for your main processes.
For more information, see: Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/
These materials will also help you regarding QMS documentation:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Primer paso en la implementación
Mi respuesta:
El primer paso que se necesita llevar a cabo es obtener el apoyo de la alta dirección. Sin este soporte la implementación de ISO 9001 muy probablemente fallará.
Otro paso crucial para asegurar que la implementación es satisfactoria, es identificar todos los requisitos que existen para el SGC de la organización. Estos incluyen los requisitos de los clientes, así como otros requerimientos como son los regulatorios y las necesidades referidas a la cultura de la empresa. Para hacer esto, es posible realizar un análisis GAP (análisis de brecha) para comparar lo que la empresa ya está cumpliendo con los requerimientos de ISO 9001:2015 y ver qué requerimientos faltan por cumplir.
Para más información, vea los siguientes artículos:
- "Lista de los pasos de la implementación y certificación de la ISO 9001" (en inglés): https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- "El uso del análisis de brecha en la implementación de la ISO 9001" (en inglés): https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/#
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/ -
Identifying risks in book Discover ISO 9001:2015 Through Practical Examples”
Answer:
I believe the book will help your company determine its risks and mitigate them. In the book, there is a particular section about determining risks. The book presents an example that can be applied to each of your company’s processes. You select a process and begin to ask yourself: what is the purpose of this process? What is the main reason, the main intended results for this process? And you ask yourself, what can go wrong? In what ways can we run away from the intended results? Then, you jump into the process and look for all the activities and their intended purpose. And you ask again: what can go wrong? In what ways can we run away from the intended results? With this you have built a list of possible negative deviations from the intended results.
According to ISO 9000:2015, risks are the effects of uncertainty on an expected result. So, you have determined the risks of that process. It is not very wise to try to change or act on everything. That is why you have to in a certain way classify your risks and act on those that are more important. The book gives a specific example, since the determination of risks, their classification and decision about what to do in order to improve the system.
The following material will provide you details with risk management:
Toolkit - ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/ -
Main focus for AS9100 Rev D product realisation
The answer:
The entire ISO 9001:2015 standard is required to create a QMS which is implemented to focus your efforts on providing products and services which meet customer needs, however, clause 8 on Operations is the main focus for requirements about your effort towards product realisation.
For more information see this whitepaper explaining the AS9100 Rev D clasues: https://info.advisera.com/9100academy/free-download/clause-by-clause-explanation-of-as9100-rev-d -
Conducting AS9100D internal audits
Answer:
Internal audits are effective when they are conducted against the QMS manual, processes and procedures. The important thing is to ensure that these processes and procedures comply to the requirements of the AS9100 Rev D standard
For more information see this article on the AS9100 internal audit: https://advisera.com/9100academy/knowledgebase/6-main-steps-in-the-internal-audit-according-to-as9100-rev-d/