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FMEA standards
IEC (International Electrotechnical Commission) developed the IEC 60812:2018 standard which is an international standard that explains how failure modes and effects analysis (FMEA), including the failure modes, effects, and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. SAE (Society of Automobile Engineers) also developed the standard for FMEA J1739:2002. This is the version from 2002, IEC version is the new version.
Both standards explain in details on how to use FMEA.
For more about FMEA please read the article: What is FMEA and how to apply it in IATF 16949 https://advisera.com/16949academy/blog/2017/09/06/what-is-fmea-and-how-to-apply-it-in-iatf-16949/ -
Time for implementation
Answer:
The duration of implementation depends primarily on the size of the organization, for example:
Smaller organizations (up to 50 employees) usually implement the standard in less than 8 months.
Mid-size organizations (up to 500 employees) usually implement the standard in 8 to 12 months.
Large organizations (500 employees and more) – implementation usually lasts 12 to 15 months.
Beware of companies that drag such projects on for too long (e.g., small companies for more than 12 months) usually never finish the project.
Start your project with an initial training about ISO 9001:2015, then perform a Gap Analysis in order to determine what needs to be done, with that you can prepare a Project Plan to drive your implementation.
The following material will provide you information about implementing a QMS:
- ISO 9001 – How long does it take to implement an ISO 9001-based QMS? - https://advisera.com/9001academy/blog/2016/07/05/how-long-does-it-take-to-implement-an-iso-9001-based-qms/
- Free ISO 9001:2015 Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- ISO 9001 Implementation Duration Calculator - https://advisera.com/9001academy/iso-9001-duration-calculator/
- 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/ -
ISO 45001 Opportunities and change management
Answer:
Clause 6.1.2.3 on the assessment of OH&S opportunities and other opportunities for the OHSMS requires that you have a process in place to identify opportunities to improve the overall OH&S performance (including hazard reduction) and other opportunities to make the OHSMS better. If you are choosing to not have a procedure for this, you can explain your process to the auditors of how you go about assessing opportunities, and give evidence of how you have acted upon your assessment. For instance, you may have taken actions to make an improvement based on an opportunity (per clause 6.1.4 planning action). You action plan and subsequent implementation would be evidence of your opportunity assessment and what you did about it.
2. Is it mandatory to introduce the format for Management of Change else how to address the clause 8.1.3
Answer:
As with clause 6.1.2.3 above, if you are not writing a procedure for clause 8.1 .3 on management of change, then you need to explain the process you have for implementing changes to your OHSMS. The whole idea of this clause is to make you consider the impact of any changes you make on the OH&S performance of your company. When there are new or changed products or services, changes in the work environment, changes in legal requirements, changes in risk knowledge or development of technology what does this mean for the OH&S risks and performance in your organization; also including unintended changes. In short, when you make changes what is your plan to mitigate against any adverse effects to your OH&S performance; how do you make changes safely? The standard doesn’t give one way of doing this change management, but you need to know what your method is.
For more information the ISO 45001 standard, see the whitepaper: Clause-by-clause explanation of ISO 45001:2018, https://info.advisera.com/45001academy/free-download/clause-by-clause-explanation-of-iso-45001 -
AS9100 and the marketing department
Answer:
Implementing a QMS using AS9100 REV D including improved reputation for customers, including the ability to bid for contracts in some aerospace industries that would not allow you to do so if you did not have the AS9100 certification in place. In general, having AS9100 implementation for the marketing department means you can promote your company’s business as taking due diligence to improve that products and services you offer, and that you are taking actions to advance the satisfaction of your customers. As with marketing AS9100 implementation to customers, the marketing department can use AS9100 to show potential customers that the company is serious about enhancing quality in the organization.
For more information on the benefits of AS9100 implementation, see the article: 7 Key benefits of AS9100 implementation, https://advisera.com/9100academy/knowledgebase/7-key-benefits-of-as9100-implementation/ -
AS9100 Rev D Record Retention
1. What is the record retention period as per AS9100 standard? We got information that in some cases we need to retain documents for 40 years.
AS9100 Rev D does not specify a record retention time. The requirement in clause 7.5.3.2 is that the organization needs to address the retention and disposition of documented information. This is because the requirements for different records can vary greatly. For the most part, record retention times for production records will come from customer contracts or legal requirements. If the 40 years time is stated in one of these places, then that is the requirement you need to meet.2. In case of hard copies of records how should we maintain it?
Many companies keep hard copy records in file storage boxes is protective spaces where they will not be damaged by fire or water. The standard only states in clause 7.5.3.2 that you need to be able to access, retrieve, and preserve these records including legibility. Again, times for retrieval may come from customer contracts. It is also common to have a supplier company keep hard copy paperwork in a secure location.3. What is the other way for retention?
It is always possible to keep records electronically, and scanning hard copy records would qualify for this. Unless you have customer requirements otherwise, scanning your hard copy records, and adequately maintaining the files in a protected fashion, is an acceptable way to maintain records.For more information on document and record control in AS9100 Rev D, see the article:
- A new approach to document and record control in AS9100, https://advisera.com/9100academy/knowledgebase/new-approach-to-document-and-record-control-in-as9100/
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Set up a new QMS
Answer:
First, I recommend training in the standard.
Second, you should do a GAP analysis to determine what must be done.
After the GAP analysis, I suggest preparing a Project Plan around the main activities with responsibilities and timings. Implement the system, perform an internal audit and the management review. Then select a certification body and agree with them dates for the first and second stage audits.
You can find more information in the following links:
- Article - Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
- Free online training - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Free ISO 9001:2015 Gap Analysis Tool - https://adviser a.com/9001academy/iso-9001-gap-analysis-tool/
- Free online training - ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ -
Monitoring, measuring, analyzing and evaluating
Answer:
When implementing a quality management system an organization determines a set of indicators or states needed to evaluate performance and make conclusions and decisions to act. Indicators or status about the quality objectives, about processes, about products and services, about customers and other interested parties’ satisfaction.
For each indicator, to plan measurement, the organization should set performance targets, frequency of measurement and analysis, responsibilities and resources needed. For each status, to plan monitoring, the organization should define the possible status qualifications instead of targets, and frequency of monitoring and analysis, responsibilities and resources needed.
According to the established frequency monitoring and/or measurement results should be determined, analyzed – compared to what was to be expected, compared to trend, compared t o what is the target performance - and evaluated if requirements are being met and to determine any needed actions and opportunities for improvement, as corrective actions, for example.
The following material will provide you more information:
- ISO 9001 - Analysis of measuring and monitoring requirements in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/analysis-of-measuring-and-monitoring-requirements-in-iso-90012015/
- ISO 9001 - How to define Key Performance Indicators for a QMS based on ISO 9001 - https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
- ISO 9001 – How to use root cause analysis to support corrective actions in your QMS - https://advisera.com/9001academy/blog/2016/03/01/how-to-use-root-cause-analysis-to-support-corrective-actions-in-your-qms/
- 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 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/ -
Territorial scope of the GDPR
Answer:
The extraterritorial reach of the GDPR is one of the new features that contribute significantly to the increased level of protection of personal data. What does extraterritorial mean? Probably one of the most important changes, the GDPR enjoys extended applicability affecting entities not established in the EU. Of course, some conditions must be met for the extraterritoriality to be applicable. The EU GDPR applies to the processing of personal data of EU data subjects, regardless of whether the processing activities take place in the EU or not. The EU GDPR is also applicable to entities established outside the EU if they offer goods or ser vices to individuals in the Union, or if they monitor the behavior of individuals in the Union (i.e., profiling activities, tracking individuals’ activities on the internet, etc.).
The key to understanding when EU GDPR is applicable is understanding the meaning of “in the Union.” The EU GDPR will only apply to personal data regarding individuals within the Union, while the nationality or habitual residence of those individuals is irrelevant. For example, a company based in the EU which is processing the data of Japanese individuals located in Japan will still need to comply with the EU GDPR. Consequently, the Japanese individuals will be benefiting from all rights according to the EU GDPR, even if these rights do not exist in their own nation’s laws.
When the data of EU citizens is processed outside of the EU by companies which are also outside the EU, then this is not considered to be “in the Union”. For example, the EU GDPR will not be applicable for a school which is based in the United States just because there is a possibility that one or several of its students would be EU citizens. In this case, the processing does not take place “in the Union,” nor is the individual “in the Union”.
One of the consequences of the extraterritorial reach is that companies not established in the EU must appoint a representative. That representative must be based in a Member State in which the relevant data subjects are based. Only a limited derogation is permitted where the processing is occasional, does not involve large-scale processing of sensitive personal data, and the purpose and result of the processing is unlikely to be a risk to individuals.
If you want to find out more about the EU GDPR check out this free EU GDPR Foundation Course (https://advisera.com/training/eu-gdpr-foundations-course//). -
27001 training
Answer:
Without more detailed information about the training you are referring about, it is not possible to give you a proper answer regarding discrepancies. What we can tell you now is for you to verify if those are accredited courses. If they are, their content will be enough for you regardless of the price (so, you could go for the cheapest one).
We'd like to offer you additional options to consider for ISO 27001 training and certification:
- ISO 2 7001:2013 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/