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M & E and ISO 9001
2. In monitoring and evaluation we look at different aspect in terms of value for money, efficiency, relevance, effectiveness, impact and sustainability how can I relate all of these with ISO?
Answer 1
If you are mentioning changes between ISO 9001 versions from 2008 and 2015, there are some. ISO 9001:2015 has a higher emphasis in performance monitoring.
Answer 2
Consider what do you want from each process and from the whole quality management system. Monitoring and evaluation is about following and making decisions based on indicators. Those indicators can measure topics like value for money, efficiency, relevance, effectiveness, impact and sustainability. For example, in a manufacturing process, indicators about defects, productivity or costs are ways of monitoring efficiency and value for money. So, they can relate very well with ISO.
The following material will provide you information about monitoring and evaluation:
- Article – Infographic: ISO 9001:2015 vs. 2008 revision – What has changed? - https://advisera.com/9001academy/knowledgebase/infographic-iso-90012015-vs-2008-revision-what-has-changed/
- How to implement the Check phase (performance evaluation) in the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/17/how-to-implement-the-check-phase-performance-evaluation-in-the-qms-according-to-iso-90012015/
- Free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
Free course - ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
GDPR compliance
In this case, the employer should ensure that any data on the device cannot be stored or processed locally.
One solution would be using a "remote desktop" solution such as Citrix. In this case, we would not be facing a data transfer. -
Scope and specific procedures
Answer:
As long as the rules applicable to each part of the business are clear, an organization can have specific procedures for each business unit under a common certificate. Consider the example of a construction company with a unique certificate but different procedures in different sites due to local legislation and different customer requirements and different kind of project.
The following material will provide you information about scope definition:
- Article – How to define the scope of the QMS accordi ng to ISO 9001:2015 -https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Which of Compliance modules in Conformio are required by the ISO 13485&14971?
Answer:
You can use following Compliance modules: Customer complaints, Nonconformities, Corrective actions and Internal audits. But you can also use the templates from the toolkit for the same purpose - whatever suits you better. -
Is there a requirement for periodically documents review?
Answer:
There are no strict requirements for a periodical document review. In the clause 4.2.4. b) is stated that update of documentation should be done as necessary .
It is, therefore, left to the choice of every organization to assess this period on their own, and to set the criteria that will determine the periodical update. The purpose of the periodic review of documents is to make sure that all processes are carried out as described. There are often times that someone accidentally makes a small change in the steps, so once the colleagues take over the project, there is a discrepancy between what was provided in the first place and what was later done.
Therefore, when determining how often you will review your documents, consider the following:
1) whether there was a large fluctuation of people
2) whether you have changed equipment, facilities, resources, location
3) whether the managers of individual processes have changed and brought some of their own policies and practices.
It is common that the documentation is reviewed every two to three years, and, in extremely small companies, with 3 to 5 people, it is possible to review it every 5 years.
To learn more about other most common errors in the documentation control, please refer to this article: https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/ . -
Writing a nonconformity
Answer
If you keep things at such an abstract level, then the clause has to be very general. I would use clause 4.4.1 because of its introduction: failure to implement or maintain processes. Normally, nonconformities are defined at a much specific level. For example, failure to follow the internal process at the commercial level can be associated to clause 8.2.
The following material will provide you information about audit nonconformities:
- Article – How to write a good ISO 9001 audit nonconformity? - https://advisera.com/9001academy/blog/2018/04/24/how-to-write-a-good-iso-9001-audit-nonconformity/
- ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
AS9100 Certification process summary
Answer:
The AS9100 implementation process goes through a few simple steps. First get management support, identify your requirements and scope and define and implement all your processes. Next rain everyone to the level needed and choose a certification body that will benefit your company. Operate your system to collect records, perform internal audit and management review to identify and corrections or improvements needed, and put in place corrective actions. Finally, the certification auditors will conduct a stage 1 documentation audit and a stage 2 certification audit where they will review all your processes against the AS9100 standard and your internal and customer requirements.
For a graphical representation of the AS9100 Rev D implementation process, see the free download: AS9100 Rev D implementation diagram, https://info.advisera.com/9100academy/free-download/as9100-rev-d-implementation-diagram] -
27001 certification audit
Thank you very much Rhand.