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One department with separate QMS
Answer:
Since this one department will have separate QMS, this system should be one independent entity and needs all QMS documents as if the rest of the company does not exist. So you should reissue and adapt all quality procedures related to this department, including Quality Policy and the objectives.
For more information, see: How to define the scope of the QMS according to ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/ -
How to start with ISO 27001
Answer:
If you are new in ISO 27001, our blog can be very useful for you, so I recommend you to see this page to learn basic information about ISO 27001, which can be your first step “What is ISO 27001?” : https://advisera.com/27001academy/what-is-iso-27001/
Regarding the implementation of ISO 27001, basically you need to see it as a project, and also is very important obtain the management support for the implementation, so this article can be interesting for you “ISO 27001 implementation checklist” : https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/
Finally, our online course is a perfect tool to learn all about ISO 27001, so I think that can be very useful for you “ISO 27001:2013 Foundations Course” : https://advisera.com/training/iso-27001-foundations-course/ -
Where to start ISO 14001 implemtntation
Answer:
The first step in implementation of ISO 14001 is to conduct GAP analysis to determine to what extent the organization already meets the requirements of the standard. The next step is to develop project plan with defined activities and documents to be created in order to achieve full compliance with the standard.
For more information, see:
- ISO 14001 Implementation diagram https://advisera.com/14001academy/free-downloads/
- 5 elements of a successful ISO 14001 project https://advisera.com/14001academy/blog/2015/03/23/5-elements-of-a-successful-iso-14001-project/ -
Excluding sales process from QMS scope
Answer:
The standard does not prescribe what will be included in the scope of the QMS and what won't be so you are free to define your scope the way that suits your needs. You only need to define it precisely in your document that describes the scope of your quality management system.
Exclusion of the sales process is not very common since it is one of the vital processes in the company. If you decide to remove the sales process from the scope, you need to be careful with some requirements that naturally go with the sales process, like communicat ion with the customer and measuring customer satisfaction.
For more information, see: How to define the scope of the QMS according to ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/ -
Environmental aspects and objectives
2. Do we need objectives for all aspects or just the significant?
Answer:
Since you are mentioning both objectives and targets, I assume you talk about ISO 14001:2004.
1. There is no explicit requirement to directly link every environmental objective with environmental aspects, but it is common practice to relate it to significant environmental aspects. The environmental objectives and targets must be only aligned with environmental policy. For more information, see: How to Use Good Environmental Objectives https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/how-to-use-good-environmental-objectives/
2. Again, the standard does not explicitly require organization to define objective for each environmental aspect, it only requires to define controls for significant environmental aspect. Very often organization define objectives related to signifi cant environmental aspect to facilitate evaluation of environmental controls effectiveness. For more information, see: Understanding relationship between environmental aspects and operational procedures https://advisera.com/14001academy/blog/2015/04/20/understanding-relationship-between-environmental-aspects-and-operational-procedures/ -
Context of the organization and risks and opportunities procedure
2. Can risks and opportunities be described within the Mgmt Review process than with a specific procedure?
Answer:
1. Context of the organization can not be considered as a static thing, it is on a contrary ever changing. The internal issues are subjected to change, not to mention the external context of the organization. Considering context of the organization or at least the changes in the context should be performed during management review, this is even a requirement of the standard (clause 9.3.2 b). For more information, see: How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
2. The standard doesn't prescribe where to describe the risks and opportunities, neither it requires risks and opportunities to be documented. Procedure for addressing risks and opportunities is not mandatory, but it may be created to facilitate identification of the risks and opportunities and planning actions to address them, but it is not common to marge this procedure with the management review process although there are some overlapping. For more information, see: Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/ -
Risk assessment, process control and management review in QMS
Answer:
Risk assessment in classical terms is not required by ISO 9001:2015, the only thing the standard requires is risk-based thinking. The standard does not require full scale risk management, or risk assessment methodology, the standard only requires organizations to identify risks and opportunities related to its ability to achieve its objectives and to create plans for addressing them. To meet the requirement for addressing risks and opportunities, it is enough to arrange the brainstorming session with relevant roles in your company and talk about risks and opportunities emerging form internal and external context of the organization. For more information, see: The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/
Process control is basically the activity or set of activities that will ensure that the process will deliver expected outputs. The controls may be engineering or technologica l meaning that some crucial parameter of the process will be controlled by using some technological solution or it can be administrative, meaning that the organization will prescribe the procedure or work instruction to ensure that the process is carried out as planned. Depending on the nature of the process and the nature of the process output the controls may vary. Here is the example of the control of purchasing process: How to control outsourced processes using ISO 9001 https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/
The purpose of the management review is to make assessment of the entire QMS and make decisions to improve the system. Similar to the previous version of the standard, the new version also requires records of management review and the standard also prescribes mandatory inputs and outputs of the management review. For more information, see: How to make Management Review more useful in the QMS https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/ -
Approval of documents and risks
If you mean to approve the risks in a review meeting, for me it is ok, if it is performed before the implementation of the risk treatment plan, and obviously the risk owners are present, and you can maintain the minutes as evidence to show approval.
For more information about the risk assessment and treatment, this free webinar can be interesting for you “The basics of risk assessment and treatment according to ISO 27001” : https://advisera.com/27001academy/webinar/basics-risk-assessment-treatment-according-iso-27001-free-webinar-demand/ -
Documenting scope without quality manual
Answer:
The quality manual is no longer mandatory according to ISO 9001:20015, if you decide not to have such document any more, you can create the document that only defines the scope of your Quality Management System. Here is the free preview of our Scope of Quality Management System https://advisera.com/9001academy/documentation/scope-of-quality-management-system/
The key processes and procedures are no longer explicitly required to be documented. The new version of the standard requires organization to determine the sequence and interaction of the processes and to document them to the extent necessary to have confidence that the processes are being carried out as planned. This means that you don't have to document everything, only the processes and activities that are critical and can have nonconformities.
That is the reason why we deci ded to keep the Quality Manual as a part of our documentation toolkit, although it is not a mandatory document, it provides a framework for fulfilling lot of different requirements in one single document.
For more information, see:
- The future of the Quality Manual in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/ -
Exclusion of clause 7.5.2 from ISO 9001:2008
Answer:
If you are only selling the fire extinguisher products, this clause would easily be excluded, however servicing of the fire extinguishing products includes testifying that they are safe for use and are working properly. This is usually done through validation and verification processes.
Validation is performed in cases when the verification can't be conducted and when it is not possible to confirm by measurement that a product or service satisfies customer request or it is not possible to conduct measurement, since product or service is being destroyed in the process .
If you have such situation, then you can not exclude the clause 7.5.2, otherwise it can be excluded, only the company needs to provide justification for the exclusion in the Quality Manual.
For more information, see:
- Understanding Product & Service Provision in ISO 9001 https://advisera.com/9001academy/blog/2014/10/07/understanding-product-service-provision-iso-9001/