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How long to keep prosthesis product in the even of knee transplant
Answer:
The Standard does not state how long a product should be kept. Generally, it should follow applicable regulatory guidelines or the projected useful life of the medial device depending on whichever is the longest. In this case, there should be documented records for traceability of the prosthesis in case of any field safety notice and recall.
For more information , please refer to
How to manage recalls and advisory notices for medical devices according to ISO 13485
https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/ -
GDPR responsibilities for small web design business
Answer:
My guess is that you are building websites for your clients thus, your clients will be the data controllers as regards to the personal data of the website users/visitors. In this case one of your main duties in terms of privacy is building the website as to allow your customers to comply with the provisions of the GDPR - this means, among other things, to provide a way to your customer to provide Privacy Notices to their visitors/users, capture and store the consent, allow personal data to be delet ed when no longer needed or anonymized.
You can find some useful documents for website compliance in our “ GDPR Mini Toolkit for Websites” ( https://advisera.com/eugdpracademy/eu-gdpr-mini-toolkit-for-websites/). -
Exclusion and non-conformity
Answer:
Yes, it results in a non-conformity. And the auditor can even consider it as a major non-conformity. With ISO 9001:2015 there is no longer the possibility for voluntary exclusion of a clause. Within the scope of the quality management system of the organization all applicable clauses must be considered.
The following material will provide you information about exclusion in ISO 9001:2015:
- ISO 9001 – 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/
- free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book - Dis cover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Auditing organizational knowledge
Answer:
Each auditor has autonomy to devise the best way to audit a particular clause of the standard. For example, I could ask:
* Can your organization evidence the determination of what knowledge is necessary for performing a function relevant for achieving process performance and/or products and services conformity?
* Can your organization evidence how that knowledge is kept alive and is shared when needed? Can be a database, can be Work Instructions, can be reports, can be sharing information meetings.
* Can your organization evidence actions to prevent knowledge loss? For example, today, I visited a company that has only one person able to perform an important task. I ask them what if the person is sick or leaves the company?
* Can your organization evidence the knowledge transmission when someone starts in a function?
* Can your organization evidence routines to be aware of new knowledge? Subscription of technical magazines? Regu lar meetings with suppliers? Partnerships with customers and/or universities? Regular participation at seminars and conferences?
The following materials will provide you details with organizational knowledge:
- ISO 9001 – How to manage knowledge of the organization according to ISO 9001 - https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/
- Free online training 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/ -
Compliance of QMS and FDA 820
Answer :
It is sufficient to have just a single set of Quality Management System in place to meet the different regulatory requirements. Any devices intended for import into the States has to comply with the requirements of FDA 820 depending on the classification and registration route of the device.
For more information, please refer to :
Differences and similarities between FDA 21 CFR Part 820 and ISO 13485
https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/ -
Guidelines for records retention
Answer:
ISO 9001:2015 does not specify any particular retention period for records. I have four rules that I follow to guide decisions about retention periods:
1. Is it required by law? If required by law, we have to keep records as long as law determines (as a minimum);
2. Is it required by a contract with customers? If required by a contract, we have to keep records as long as the contract determines (as a minimum);
3. Is it useful to track changes or evolution along time? If that is the case, I recommend keeping records for 4 years to ensure that the organizations keep a memory that always includes the totality of the 3-years certification cycle;
4. All other records can be kept for one year.
The following material will provide you information about documented information control:
- ISO 9001 – New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- free online training 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/ -
Quality Plan, Objectives and KPIs
Best regards
Answer:
Quality objectives are overall goals or targets stated by the organization in order to achieve improvement within the QMS. These quality objectives can be measured by the KPI´s which are individual or specific activities defined in order to monitor and measure a stablished target/goal. Usually most quality objectives are supported by many KPI´s. For example, an objective can be increasing turnaround by 5% while KPI´s could be increasing sales activities by 8% and reducing bussiness costs by 5%.
You need to keep in mind that while quality objectives are a mandatory requirement in ISO 9001:2015, KPI´s are just optional.
Quality Plan is a list of arrangements needes for the creation of a product or serviec including the necessary tools, process steps, measurement points and other information.
These materials can help you to understand the differences between objectives, KPIs and a Quality Plan:
- Article - How to define Key performance indicators for a QMS based ISO 9001: https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
- Article - How t write good quality objectives: https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
- Article - What has changed with quality objectives in ISO 9001:2015: https://advisera.com/9001academy/blog/2018/05/08/what-has-changed-with-quality-objectives-in-iso-90012015/
- Article - Making the best out of ISO 9001 quality plan: https://advisera.com/9001academy/blog/2015/12/08/making-the-best-out-of-iso-9001-quality-plan/
- Free on-line course - ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/ -
Calibration in ISO 9001:2015
Answer:
According to ISO 9001:2015 getting calibration from ISO 17025 is not a requirement. However, all monitoring and measurement equipment used for product and process verification must be controlled and calibrated against national or international traceable standards at specified intervals, so basically you can decide which standard best fits your needs, but where such standard does not exist you need to record what was used
To learn more about calibration in ISO 9001:2015, you can see these materials:
- Article - Monitoring measurement equipment control: https://advisera.com/9001academy/blog/2014/05/06/monitoring-measurement-equipment-control/
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/ -
HR document release
Answer:
First you have to identify what your HR controls state about this situation. If the document was released in a way different from what is defined by them, or they define that the document must not be released at all, then you have a non conformance.
Now, regarding a possible incident, you have to evaluate if this release has caused any negative impact to the person to which the document relates to, or if this release has breached any legal requirement you have to comply with.
These article will provide you further support to evaluate this information:
- Information classification according to ISO 27001 https://advisera.com/27001academy/blog/2014/05/12/information-classification-according-to-iso-27001/
- How to handle incidents according to ISO 27001 A.16 https://advisera.com/27001academy/blog/2015/10/26/how-to-handle-incidents-according-to-iso-27001-a-16/ -
Template content
Document: Statement of Applicability
Section: „Implementation-Method“
If you have different documents to fulfill the control and between them you put this sign: „/„. Does it mean you can choose between one of them?
Answer:
If two documents are mentioned with the slash sign "/", this means you should choose either the first or the second document. In case the documents are mentioned with comma "," this means you should implement both documents for a particular control.
You may have missed this one, but you can find this information in the comment on the title of the column "Implementation method" of the Statement of Applicability template. We include comments like this one on important issues of each template to make the understanding and filling of the documents easier by the users.