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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. -
Roles and responsibilities of Junior Management
Answer:
ISO 9001:2015 only specifies responsibilities for what is called “top management” (see clause 5.1.1). In each organization it is top management that has the authority to determine which roles are needed, and what are the responsibilities and authorities for each role (see clause 5.3). So, in any organization, it is within top management authority to determine what are the roles and responsibilities of Junior Management, and those roles and responsibilities can change, can grow with time and experience.
The following material will provide you information about roles and responsibilities:
- ISO 9001 – How to document roles and responsibilities according to ISO 9001 - https://advisera.com/9001academy/blog/2018/02/26/how-to-document-roles-and-responsibilities-according-to-iso-9001/
- free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book - Discove r ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Transition of OHSAS 18001 to ISO 45001
1. What are the reasons for replacing OHSAS 18001?
2. Which approach is perfect for the implementation of 45001, functional or systematic? Why that approach?
Answer:
1. OHSAS 18001 was not an international ISO standard, but was instead maintained by BSI. As such it was not agreed upon by the member countries of ISO as the internationally recognized benchmark for an OH&SMS. With the release of ISO 45001 this is now the case, and in the near future you should expect to see BSI stop updating OHSAS 18001 and then making it obsolete.
2. As ISO 45001 is a management system then the approach of looking at your implementation as a system is important. This does not mean that understanding what certain functions need to do is unimportant, and assigning the roles and responsibilities of functions needs to be done. If you already have your management system in place, it does help to look at how the requirements for the system have changed, and then focus on how each functional responsibility needs to change within your system to meet the new requirements.
For information on a good process for transitioning your OH&SMS from OHSAS 18001 to ISO 45001 see this free whitepaper "Twelve step transition process from OHSAS18001 to ISO 45001": https://info.advisera.com/45001academy/free-download/twelve-step-transition-process-from-ohsas-18001-to-iso-45001 -
Product Sample ISO 13485
Answer:
The Standard does not state how long the sample 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.
For more information, please refer to :
Record of Production Process Validation
https://advisera.com/13485academy/documentation/record-of-production-process-validation-iso-13485-2016/