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Getting certified
Answer:
Since you did't stated against what standard you want to get certified, I assume you've meant ISO 9001. In order to get certified, you need to implement the standard first and there are some similar steps for every management system standard.
First step in implementation is to conduct a gap analysis to determine to what level your company is already compliant with the standard and what needs to be done to achieve full compliance. Here you can find our free GAP analysis tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
Once you determine what needs to be done, you should develop a project plan for the implementation to define what activities needs to be taken, what documents need to be produced as well as responsibilities and deadlines. Here you can find free Project Plan for ISO 9001 Implementation https://info.advisera.com/9001academy/free-download/project-plan-for-iso-9001-implementation-ms-word
Then you can start implementing requirements of the standard and when everything is finished, you should conduct internal audit and management review to make sure that your Quality Management System is compliant with the standard.
Finally, you will be ready to hire certification body that will come to your company, conduct the audit and issue you the certificate. For more information about the implementation and certification, see: Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/ -
Root cause analysis on ISO 27001
but on Procedure_for_Corrective_Action_EN.docx not mention any root cause analysis and how to implement it. -
Clean desk procedure
Answer: Generally a clear desk procedure is not required, being sufficient performing periodic awareness and monitoring activities to evaluate policy effectiveness.
This article will provide you further explanation about clear desk policy:
- Clear desk and clear screen policy – What does ISO 27001 require? https://advisera.com/27001academy/blog/2016/03/14/clear-desk-and-clear-screen-policy-what-does-iso-27001-require/ -
Why implementing ISO 27001?
Answer: Besides reducing the likelihood of security incidents, the companies that implement ISO 27001 can achieve other benefits as well - getting new clients, better organizing their processes, quicker compliance with laws and regulations, etc.
All these benefits are explained here: Four key benefits of ISO 27001 implementation https://advisera.com/27001academy/knowledgebase/four-key-benefits-of-iso-27001-implementation/ -
QMS in pharmaceutical distribution company
Answer:
You are correct, the definition of the scope is one of the crucial steps in ISO 9001 implementation and the way you determine the scope will guide you through the next steps. Since you are only distributor of the pharmaceutical products and not a manufacturer, many of clauses of the standard will not be applicable to your QMS, Therefore you wont be needing as many documents as some production company.
You will be able to exclude design and development, production and many other processes and requirements so your system will be much smaller in therms of documentation. For more information, see: What clauses can be excluded in ISO 9001:2015? https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/ -
Change classification
Answer: Changes are, usually, classified according to the risks and costs they have. Here are criteria for Normal changes: 1. Minor change - low risk and/or low cost 2. Significant change - medium risk and/or cost 3. Major change - high risk and/or cost This article can provide few more details: "Three key elements of assessment and evaluation of changes according to ITIL" -
ISO 27001 ISMS into ISO 13485 QMS
Answer: If the system's scopes have sufficient overlap, considering their integration it is a good option to optimize organization's efforts and resources. Additionally all ISO management systems published after 2012 have the same general structure, and this make integrating them a lot of easier.
This article will provide you further explanation about integrated management systems:
- How to implement integrated management systems https://advisera.com/articles/how-to-implement-integrated-management-systems/
These materials will also help you regarding integrated management systems:
- 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 webinar – ISO 27001 implementatio n: How to make it easier using ISO 9001 https://advisera.com/27001academy/webinar/iso-27001-implementation-make-easier-using-iso-9001-free-webinar-demand/ This webinar can give you insights that can be applied to ISO 13485. -
Environmental objectives, targets and programs
Answer:
Keep in mind that requirements for targets and programs belong to 2004 version of the standard, 2015 version of the standard only has environmental objectives and plans to achieve them.
In ISO 14001:2004, environmental objectives are more general and provide directions for environmental targets that are more specific. The programs represent a set of activities to enable organization to achieve and monitor and measure achievement of the environmental objectives and targets. For example, your environmental objective can be to decrease pollution, and one of the targets can be to decrease CO2 emissions by 20%, the program would be to install the filters and monitor the CO2 emission.
For more information, see: How to write ISO 14001 environmental targets for your organization https://advisera.com/14001academy/blog/2015/05/25/how-to-write-iso-14001-environmental-targets-for-your-organization/
Here you can download free preview of our template Environmental Objectives and Plans for Achieving Them https://advisera.com/14001academy/documentation/environmental-objectives-targets-and-programs/ -
ISO 27001 trainings
Answer: To undertake our practice exams you only have to enroll for course you want and go through the whole course before taking the exams. It is totally free. If you wish to go for the certification you will have to purchase the exam and schedule the time at you convenience.
Here are the links if you want to access the practice exams:
- ISO 27001:2013 Foundations Course https://advisera.com/training/iso-27001-foundations-course/
- ISO 27001:2013 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/
And these are the links if you want to purchase an exam eligible to certification:
- ISO 27001:2013 Foundations Course exam eligible to certification https://www.bluesnap.com/jsp/buynow.jsp?contractId=3287768
- ISO 27001:2013 Internal Auditor Course exam eligible to certification https://www.bluesnap.com/jsp/buynow.jsp?contractId=3287770
Here you can find other information about our online courses:
- Online courses FAQ https://advisera.com/support/knowledgebase_category/online-courses/ -
Implementing ISO 27001 with Documentation toolkit
Answer: Yes. Since ISO 27001 is an international standard, we developed our toolkits, including those for consultants, following the same standard's principles regarding their use by organizations all around the world, so the toolkit will help you implementing ISO 27001 regardless the country where the organization is.
At the moment we do not have the toolkit translated to Japanese (languages available are English, Deutch, Spanish, Dutch, Croatian, Portuguese, French, Russian and Polski.
This article will provide you further explanation about ISO 27001 implementation project:
- ISO 27001 implementati on checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/
These materials will also help you regarding ISO 27001 implementation project:
- 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/
- How to use a Documentation Toolkit for the implementation of ISO 27001 [free webinar] https://advisera.com/27001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-27001-free-webinar-on-demand/