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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/ -
Measuring quality objectives
Answer:
In order to be able to measure achievement of the objective, you need to set measurable objective. This means that you have to establish quantifiable objectives and also to define some timeframe for achievement of the objective.
For example, if you take for the objective to increase customer satisfaction, you cannot determine whether the objective is met if the customer satisfaction is increased for 5, 10 or 20%. Also, if there is no timeframe for the objective, you cannot measure its level of achievement. In the same example, you cannot determine if the customer satisfaction should be decreased within one o several years period.
The proper objective would be to increase customer satisfaction by 10% in 2017. In this way, by the end of the year you can determine whether the objective is met or not and to what extent. The general rule for quality objectives is to be SMART (Specific, Measurable, Agreed-upon, Realistic, Time-framed).
For more information, see: How to Write Go od Quality Objectives https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
These materials will also help you regarding quality objectives:
- 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/ -
Examples for the risk assessment and risk treatment
We received this question:
>Thank you for answering the question. But, I was looking for actual examples rather than how to fill out the table. Something that would put me on the right track for actually identifying assets and selecting the proper threats and vulnerabilities for each asset. I don't want to add assets that shouldn't be included and I don't want to miss something that should be included. I did look at the asset categories in the excel sheet. Is there something else that is similar and more detailed?
Answer: I think maybe this material can help you:
- Diagram of ISO 27001:2013 Risk Assessment and Treatment process https://info.advisera.com/27001academy/free-download/diagram-of-iso-270012013-risk-assessment-and-treatment-process
This diagram can provide you an example of an overview of the connections between an asset and related threats and vulnerabilities.
If you need additional help with this process, also included in your toolkit you can schedule a meeting with one of our experts, so you can provide specific scenarios for him to help you work with th e assets that really matters to your organization. You can use this link to schedule a meeting: https://advisera.com/27001academy/consultation/ -
Mandatory procedures and ISO 9001:2015
Answer:
ISO 9001:2015 has no mandatory procedures required. It is up to each organization to decide to what extent it needs more or less documentation to support the operation of its processes. For example, organizations can use more documentation when processes are more complex, when turnover is high, when there is less training and experience, when there is a track record of quality problems. As an auditor, when there are no written procedures, one can give more attention to intended results and actual performance as the basis for audit preparation and realization.
These materials will also help you regarding the topic of preparing an audit:
• article - ISO 9001 Audit Checklist - https ://advisera.com/9001academy/knowledgebase/iso-9001-audit-checklist/
• article - Writing an Audit Checklist for ISO 9001 Processes - https://advisera.com/9001academy/blog/2014/11/25/writing-audit-checklist-iso-9001-processes/
• article - How to create a check list for an ISO 9001 internal audit for your QMS - https://advisera.com/9001academy/blog/2016/07/12/how-to-create-a-check-list-for-an-iso-9001-internal-audit-for-your-qms/
• article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
• free online training ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
• book - ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/ -
Revisión de los requisitos de Producto/Servicio
Antes de que una organización acuerde suministrar un producto o servicio, es crucial que los requisitos no sólo sean identificados, sino también revisados por la empresa.
Es importante mantener unos buenos registros de la revisión y aceptación de cualquier pedido para asegurar que cualquier cambio es comunicado a todos los empleados que necesitan implementar los cambios. Asimismo, en algunos casos una revisión de cada uno de los pedidos puede ser poco práctico (como ventas a través de internet), aunque una revisión de la información de un producto relevante (como catálogos o materiales de publicidad) pueden ser adecuados, ya que éstos pueden ser utilizados en lugar del pedido.
Para más información vea "Cómo funcionan los requisitos de producto en ISO 9001"(en inglés) : https://advisera.com/9001academy/blog/2014/04/08/product-requirements-work-iso-9001/#
Estos materiales también pueden ayudarle con la documentación de ISO 9001 :
- Libro "Gestión de documentación ISO: una guía en un lenguaje sencillo": https://advisera.com/books/gestion-de-documentacion-iso-una-guia-en-un-lenguaje-sencillo/
- Curso gratuito 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/ -
Business Continuity in SLAs
How can we bind third party vendor to provide service or what will be the responsibilities of third party vendor in case of disaster due to conditions mentioned in force majeure.
I have this query related to specific vendor like security guard service provider, Electrical service provider and IT Desktop support service provider.
Answer: Regarding the force majeure clause, you do not have many options to handle it. Your organization can either try to define in the service agreement specific situations where the clause does not apply (in these cases the vendor will have to include in the service agreement how it will handle these situations), or choose vendors which do not have this clause.
These articles will provide you further explanation about supplier management:
- 6-step process for handling supplier security according to ISO 27001 https://advisera.com/27001academy/blog/2014/06/30/6-step-process-for-handling-supplier-security-accor ding-to-iso-27001/
- Which security clauses to use for supplier agreements? https://advisera.com/27001academy/blog/2017/06/19/which-security-clauses-to-use-for-supplier-agreements/ -
ISO 27001 controls validation
Answer: To start with your validation of controls, I suggest you to start with our free ISO 27001 Gap Analysis Tool (https://advisera.com/27001academy/free-iso-27001-gap-analysis-tool/). This tool can provide you a quick overview of how much of ISO 27001 you have implemented so far (management requirements and controls also).
For a more formal and systematic approach I suggest you to take a look at the free demo of our ISO 27001/ISO 22301 Internal Audit Toolkit (https://advisera.com/27001academy/iso-27001-22301-internal-audit-documentation-toolkit/). This toolkit is composed of the following documents: Internal Audit Checklist, Procedure for Internal Audit, Annual Internal Audit Prog ram, and Internal Audit Report, and will help you to plan, perform and document the results of an internal audit compliant with ISO 27001
These articles will provide you further explanation about internal audit:
- How to prepare for an ISO 27001 internal audit https://advisera.com/27001academy/blog/2016/07/11/how-to-prepare-for-an-iso-27001-internal-audit/
- How to make an Internal Audit checklist for ISO 27001 / ISO 22301 https://advisera.com/27001academy/knowledgebase/how-to-make-an-internal-audit-checklist-for-iso-27001-iso-22301/
These materials 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/ -
Developing design and development procedure
Answer:
The procedure should explain the process of design and development. The level of details will depend on the competency of the people included in the design and development process. The more competent they are, the less information is needed in the procedure.
Design and development procedure should cover the following topics:
- Design and development planning
- Design and development inputs
- Design and development controls
- Design and development outputs
- Changes management in design and development process
For more information, see: 7 steps in writing QMS policies and procedures for ISO 9001 https://advisera.com/9001academy/blog/2015/03/10/7-steps-in-writing-qms-policies-and-procedures-for-iso-9001/
Also, you can download free preview of our Procedure for Design and Development [ https://advisera.com/9001academy/documentation/procedure-design-development/
These materials will also help you regarding design and development procedu re:
- 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/