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Using a Document Management System Software
Answer:
We can recommend our own software, Conformio. You can open a free account at Conformio – you’ll have free access for 10 users to the unlimited features of the document management system compliant with ISO 9001, ISO 14001, and ISO 27001.
The following material will provide you information about Conformio :
Article – Should you keep your ISO documents in the cloud or on paper? - https://advisera.com/conformio/
- What kind of Document Management System (DMS) do you need for handling ISO documents? - https://advisera.com/conformio/blog/2020/08/11/what-kind-of-dms-you-need-for-handling-iso-27001-documents/
- Free course – ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - D iscover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
ISO 27001 presentation and training
Answer:
For presenting an ISO 27001 project to employees and some training we recommend these materials:
- Why ISO 27001 – Awareness presentation https://info.advisera.com/27001academy/free-download/why-iso-27001-awareness-presentation
- Security awareness training https://advisera.com/training/awareness-session/security-awareness-training/
The first material is a short presentation intended for employees that shows what ISO 27001 is all about, why is it good for the company – and also for themselves, and what is their role in handling information security. It is a template you can adjust to fulfill your needs.
The sec ond material is an online security awareness program which will help you educate your employees by providing simple techniques for protecting company information assets. -
What should be question for getting feedback from production of product?
What should be question for getting feedback from production of product?
Answer:
Feedback from production would be questions pertaining to the safety and performance of the product, e.g:
-Is there any OOS (out of specification) detected during QC of the product?
-Is the process in place efficient to ensure that the product meets the final specifications?
-Are there any recurring issues in the production of devices?
For mor e information, read this article :
Production and service provision process in ISO 13485
https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/ -
Should the company be ISO 13485 certified while outsourcing assembly service?
Answer:
You should get a company who is certified in ISO 13485 to do the assembly for you as assembly of a medical device falls into part of the manufacturing process of a medical device. Since you are handling the design and development of the device, this will also fall into part of the process which ISO 13485 covers. The scope of ISO 13485 covers design and development, manufacturing, distribution, servicing and installation activities of medical devices. Getting ISO 13485 would help you to obtain regulatory approvals and clearance for your marketing activities in the future.
For more information, please read articles:
Importance of ISO 13485
https://advisera.com/13485academy/what-is-iso-13485/
Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/ -
FAI requirement in AS9100 Rev D
Answer:
Clause 8.5.1.3, Production process verification, contains the requirements which are commonly referred to as First Article Inspection (FAI). The requirements are basically that you take a representative item from the first production run of a new or modified product and use it to prove that everything works (processes, documentation, tooling, etc).
While this is not identified as an optional process (where the standard says “as required”, you do have the ability to claim exclusion from this clause as you do with all clauses. So if the exclusion is that this is only applicable when required by customer, this is acceptable in AS9100.
For more on how FAI works, see the article: How does First Article Inspection fit into AS9100 Rev D?, https://advisera.com/9100academy/blog/2017/11/07/how-does-first-article-inspection-fit-into-as9100-rev-d/ -
Australian version of ISO 27001
We've received additional questions:
>1. In such situation, would organisations need to implement ISMS based on ISO version or nationalized version?
Answer: This decision will depend mostly if you have contracts, laws or regulations demanding the implementation of the nationalized version. If not the best course of action would be to go for the ISO version.
>2. Is nationalized version only to understand the standard and not for accreditation?
Answer: The nationalized version is as good for certification as the ISO version, with the limitation that it will be recognized only in the country that released it. Sometimes the nationalized version includes additional requirements for a specific country, but these are not in conflict with the ISO version requirements. -
What is ISO 9001?
Answer:
The most important standard about quality management systems is ISO 9001 together with ISO 9000.
The following material will provide you information about ISO 9001 :
Article – What is ISO 9001? - https://advisera.com/9001academy/what-is-iso-9001/
- ISO 9001 Requirements and Structure - https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/
- Free course – ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Document for compliance
4.4. Quality Management System and its processes
Our company has established and implemented the QMS, which is maintained and continually improved according to the requirements of the IATF 16949:2016 standard and customer-specific requirements, including processes needed and their interactions.
We have determined the processes needed for the QMS and their application through the organization. Also, we have determined required inputs and desired outputs of the processes, criteria, and methods needed for effective operation and control of these processes, as well as resources needed and responsibilities and authorities for processes in the Quality Plan. Sequences and interactions between the processes are described in Figure 2: Process Map.
*Rules regarding product and process conformity to statutory, regulatory, and customer requirements are defined in [document name], including outsourced processes and service parts.*
Answer:
It is common practice that an organization has a list of laws and other legislation that is impacting the organization. In this list, the organization needs to answer if it complies with legislative in the operating country, or if it needs to apply measures in the future in order to be fully compiled. Also, this can be outsourced to other organization specialized in legislative.
This requirement is typical for all management systems and when it comes to IATF 16949 it can be more difficult if you are working in more than one country.
Document from the toolkit named “Appendix 1 – List of Interested Parties and Customer Specific Requirements“, in the folder: 04_Procedure_for_Determining_Context_of_the_Organization_and_Intereste d_Parties or https://advisera.com/16949academy/documentation/list-of-interested-parties-and-customer-specific-requirements/ can be used by identify Government as interested parties and fill all the legislative they must comply with. You can also add the level of compliance and action plan.
For more information, take a look at this article:
https://advisera.com/9001academy/blog/2017/02/14/how-to-include-statutory-and-regulatory-requirements-in-your-qms/ -
Lead implementer and lead auditor
Answer: These are the main differences:
- ISO 27001 Lead Implementer course – teaches how to implement the standard.
- ISO 27001 Lead Auditor course – teaches how to audit an ISMS against ISO 27001 requirements.
These articles will provide you further explanation about ISO 27001 courses:
- What does ISO 27001 Lead Implementer training look like? https://advisera.com/27001academy/blog/2016/11/28/what-does-iso-27001-lead-implementer-training-look-like/
- What does ISO 27001 Lead Auditor training look like? https://advisera.com/27001academy/blog/2016/08/29/what-does-iso-27001-lead-auditor-training-look-like/
- Lead Auditor Course vs. Lead Implementer Course – Which one to go for? https://advisera.com/27001academy/blog/2014/06/16/lead-auditor-course-vs-lead-implementer-course-which-one-to-go-for/
Here are the courses that are provided by Advisera:
- ISO 27001:2013 LEAD AUDITOR COURSE https://advisera.com/training/iso-27001-lead-auditor-course/
- ISO 27001:2013 LEAD IMPLEMENTER COURSE https://advisera.com/training/iso-27001-lead-implementer-course/ -
Implementing business continuity
in order to implement iso 22301 do we need to have a BIA, BCP, test, etc.. for each of these functions as processes or how it works?
your assistance and help will be reflected on my understanding on how to implement.
Answer: According to ISO 22301 you have to consider BCP, test and other elements of business continuity only for process that if disrupted for a certain time can cause irreversible damage to the organization.
To identify such processes you have to perform a business impact analysis to understand how disaster ca affect your operations.
These articles will provide you further explanation about business continuity management:
- What is ISO 22301 https://advisera.com/27001academy/what-is-iso-22301/
- How to implement business impact analysis (BIA) according to ISO 22301 https://advisera.com /27001academy/knowledgebase/how-to-implement-business-impact-analysis-bia-according-to-iso-22301/
- Business continuity plan: How to structure it according to ISO 22301 https://advisera.com/27001academy/knowledgebase/business-continuity-plan-how-to-structure-it-according-to-iso-22301/
These materials will also help you regarding business continuity management:
- Implementing Business Impact Analysis according to ISO 22301 [free webinar on demand] https://advisera.com/27001academy/webinar/implementing-business-impact-analysis-according-to-iso-22301-free-webinar-on-demand/
- Writing a business continuity plan according to ISO 22301 [free webinar on demand] https://advisera.com/27001academy/webinar/writing-a-business-continuity-plan-according-to-iso-22301-free-webinar-on-demand/
- Book Becoming Resilient: The Definitive Guide to ISO 22301 Implementation https://advisera.com/books/becoming-resilient-the-definitive-guide-to-iso-22301-implementation/