Start a new topic and get direct answers from the Expert Advice Community.
CREATE NEW TOPIC +Guest
Sometimes I think the same. Sometimes I think there is a “political” use of the classification. As a general rule, you can follow that a major nonconformity is a situation where an organization:
Completely failed to fulfill a certain requirement.
Has a process that has completely fallen apart – rules are not followed systematically.
Has several minor nonconformities that are related to the same process or to the same element of the management system
If a certification mark is misused
If a minor nonconformity, raised during the previous audit, has not been resolved within the deadline – such a small nonconformity automatically becomes a major one.
You can find more information in the following links:
Yes, you are right that MDR does not state that this should be ISO 13485. However, in Article 8 – Use of harmonized standards is stated that manufacturers must be in compliance with standards that are published in the Official Journal of the European Union. Currently available is the list published 17- 11-2017. On that list is more than 300 standards and the only standard that is covering the quality management system is ISO 13485:2016. That is why it is expected for the manufacturers of medical devices to have implemented ISO 13485:2016.
Of course, since there are a lot of standards on that list that have since been revised, it is expected that a new list of harmonized standards will be published after 26 May 2021, with regard to the full entry into force of the MDR.
For more information, see:
The following documents may cover the documents you mentioned (you should consider seeing their free demo to evaluate if they can fulfill your needs):
- Threat management policy and/or process: Incident Management Procedure https://advisera.com/27001academy/documentation/incident-management-procedure/
- Policy and/or monitoring strategy: Security Procedures for IT Department https://advisera.com/27001academy/documentation/security-procedures-for-it-department/
- Data management policy (rest, in transit and in third parties): Information Classification Policy https://advisera.com/27001academy/documentation/information-classification-policy/
- Risk Impact Analysis (RIA): Risk Assessment and Risk Treatment Methodology https://advisera.com/27001academy/documentation/Risk-Assessment-and-Risk-Treatment-Methodology/
- Crisis Plan: Business Continuity Plan https://advisera.com/27001academy/documentation/business-continuity-plan/
For the remaining documents, they are not included in the toolkit because they are not commonly used in an ISO 27001 implementation, but in case you need to document them and find it difficult to write them by yourself, by buying the toolkit you will have access to support channels that you can use to clarify your doubts on how you should write them.
I’m assuming you are referring to ISO 27001.
Considering that, to implement ISO 27001, broadly speaking, after getting support for your project (through approval of the ISMS project plan) and approval of the Procedure for Document and Record Control, you should consider these steps:
To see how documents compliant with ISO 27001 look like, I suggest you take a look at the free demo of our ISO 27001 Documentation Toolkit at this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/
This article will provide you a further explanation of ISMS implementation:
These materials will also help you regarding ISO 27001 implementation:
How is the compliance of each ITEM verified?
Compliance verification is performed by means of an internal audit. For the preparation for an internal audit you should consider these general steps:
These articles will provide you a further explanation about internal audit:
These materials will also help you regarding internal audit:
Factors from a PESTLE analysis are external issues. Considering your organization’s strategic orientation and relevant interested parties you can classify those factors as positive or negative (opportunities or threats). If you do the same exercise for internal factors you can classify them as positive or negative (strengths or weaknesses).
Now, you can match opportunities with strengths or weaknesses, and you can match threats with strengths or weaknesses, and what you get is a set of risks and opportunities.
Although about ISO 9001, perhaps the technique that I use and present in this free webinar on-demand - Context of the organization, interested parties, and scope - - may be useful for you to work with context and interested parties to determine risks.
Please check this information below with more detailed answers:
Start by reading these articles - 6 Key Benefits of ISO 14001 - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/6-key-benefits-of-iso-14001/ and - ISO 14001: The benefits for customers - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/ - can you use one or more topics from the articles to support your proposal. Can your organization win new clients that demand ISO 14001 certification? Can your organization reduce costs due to a systematic improvement of environmental issues? For example, while implementing an environmental management system I was able to reduce costs and improve productivity by changing to water-based adhesives instead of solvent-based ones.
You can find more information below with more detailed answers:
It is the adopted version (the old one) because the draft of new Standard Contractual Clauses (SCC) is not officially adopted.
If you need to understand how to use SCC, you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//
According to Article 8 GDPR, the processing of children’s data requires consent from their parents or from the person holding parental responsibility over them. Even if the legal ground is a contract, the child cannot enter into a contract without parental consent.Recently, some social networks had been fined by Surveillance Authorities because it was not implemented a system to verify the age of the user and require parental consent.
The Toolkit includes a Laboratory Information Management System (LIMS) Validation Register and generic template for a LIMS record. These are associated with the Quality Assurance Procedure. The record guides the user to record the purpose and type of test planned. Then the Test case and Procedure , Acceptance criteria and Comments / Action required can be recorded. All the other felds are provided, for example for additional comments / monitoring of risk, record of person performing the validation and approving the validation.
It is the laboratory’s role to identify the criteria and list them in the record. This reinforces the awareness and consideration of the needs. The latest Part 11, Electronic Records; Electronic Signatures - Scope and Application is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
To view a preview of the Advisera 17025 toolkit and the LIMS register and record, you can go to https://advisera.com/17025academy/iso-17025-documentation-toolkit/
AS9100 Clause 8.2.3 is about the review of requirements for products and services, and clause 8.2.3.2 is a subclause to this. So in clause 8.2.3.1 you review if you are able to meet all of the requirements for your products and services (customer, legal, other), and clause 8.2.3.2 is telling you that you need to keep records on what you found in your review (the results of the review). For example, could you meet everything, did you change requirements due to customer agreement, etc.
As this is common to ISO 9001, you can read mor in this related 9001Academt article: How Product Requirements work in ISO 9001, https://advisera.com/9001academy/blog/2014/04/08/product-requirements-work-iso-9001/