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QMS FOR SKILLS DEVELOPMENT

If you need to learn about quality management systems for your skills development, I invite you to start with our ISO 9001:2015 Foundations Course. You can enroll for free. During the course you can select a theme and search our blog or our webinars about it, they are free. You can also buy one of our books about ISO 9001

The following material will provide you more information about ISO:

- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Free webinars - https://advisera.com/9001academy/webinars/
- Blog - https://advisera.com/9001academy/blog/
- Books about ISO 9001 – https://advisera.com/books/iso-standard/iso-9001/

ISO 14001 requirements

As I mentioned before, information about VW can be found in its “2018 Sustainability Report” (page 34) - https://www.volkswagenag.com/presence/nachhaltigkeit/documents/sustainability-report/2018/Nonfinancial_Report_2018_e.pdf

When it comes to Ford and GM, I remember a quality forum in 2000 where many tier 1 suppliers mentioned that in that day they received letters from GM, Ford, Chrysler, Honda with date to be certified. 

An organization cannot get a Ford Q1 status without being ISO 14001 certified – please check “Ford GRI INDEX 2018/19” (pages 16 and 17) - https://corporate.ford.com/microsites/sustainability-report-2018-19/assets/files/sr18-gri.pdf

In the case of GM I could not find any official document stating what they requested in 2000.

iso27001 LI course with the workshop / which certificate do you provide?

Unfortunately, at this moment our iso27001 LI exam is not accredited, but we are in the accreditation process at this moment. As soon as this process is concluded our customers will be contacted.

All other exams we provide are accredited (ISO 27001 Internal Auditor and ISO 27001 Lead Auditor).

This article will provide you further explanation about ISO 27001 Lead Implementer course:
- What does ISO 27001 Lead Implementer training look like? https://advisera.com/27001academy/blog/2016/11/28/what-does-iso-27001-lead-implementer-training-look-like/

QMS and EFQM model

You can find below my answers to your questions:

1. These are the similarities between an QMS and EFQM model:

- In ISO 9001:2015 we find interested parties while in the EFQM model we have the the similar concept of  stakeholders

- Context of the organization

- Strategic direction

- Risk based thinking

- Performanca evaluation

- Organizational knowledge management

These are the differences:

In the case of EFQM these are requirements not covered by ISO 9001:

- is focused in results of planning, measurement and achievement

- mentions financial performance, which is not covered in ISO 9001

- there is a clear relationship between cause and effect

- includes a detailed assessment and scoring while in ISO 9001 there are auditing requirements, that could be more subjective

In the case of ISO 9001 these are requirements not covered by EFQM model:

-  Internal audit

- Control of documented information 

- Quality improvement covered by: correction and corrective actions, continual improvement, etc.

- Operation requirements, such as operational planning and control, product and service requirements, design and development, control of providers, product and service provision, etc. 

Both the ISO 9001 standard and the EFQM Model rely on this philosophy to develop its operation. However, while ISO 9001 focuses on defining minimum requirements that organizations using this standard must meet, the EFQM Excellence Model aims to achieve perfection, without defining minimum requirements and seeking guide organizations about what aspects are good at and what aspects they can be improved.

2. You can integrate them, however you need to think if that is really worth for your organization, since both seek quality of products and services. 

3. You don´t have to comply with mandatory documentation in the EFQM model as you need to do with ISO 9001:2015. In the EFQM model you need to comply with a Self-Assessment against 9 criteria and your Action Plan. 

Here you can find a list with the mandatory documents and records in ISO 9001:2015 - List of mandatory documents required by ISO 9001:2015: https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

4. If you integrate will require some extra effort while if you decide just to go for one model you can focus your quality of products and services in just one direction. See which one benefits your organization most and go for it. EFQM is mostly used for European organizations while ISO 9001:2015 is globally recognized.

For more information about the benefits of ISO 9001:2015, see this article - Six key benefits of ISO 9001 implementationhttps://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/

These materials can help you to understand better ISO 9001:2015 and EFQM model:

- 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/

Adoption of externally acquired reference material

There were no changes in requirements about external documents in the transition from ISO 9001:2008 to ISO 9001:2015. External documents relevant for the quality management system should be identified and controlled. Please see the penultimate paragraph of ISO 9001:2015 clause 7.5.3.2

Determining the relevant interested parties is the first step in determining what kind of external documents can be relevant for your quality management system.

The following material will provide you more information about external documents:

- Article - What does “external documents control” mean in ISO 9001? - https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/
- Article - How to determine interested parties and their requirements according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/
- Free webinar - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/
- Enroll for 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/
 

Terminology For machinery and equipment

I am looking for the terminology that would be used when a company is producing machinery and equipment. Can you help

Regulatory requirements under ISO 9001:2015

There is no universal rule, that depends of each country and economic sector.

Some organizations have contracts with law firms, some pay to companies that monitor legislation, some belong to sector associations that perform that service (both for legislation and standards), some belong to groups that work with national standardization bodies and have access to what is being developed and will be applied. Some check the internet daily, monitoring any new output from regulatory bodies.

The following material will provide you information about the external documentation:

- Article - What does “external documents control” mean in ISO 9001? - https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/
- 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/

Audit evidence

For information about interfaces and integration between ISO 20000 and ISO 27001, I suggest you take a look at this free downloadable material:
- ISO 27001 vs. ISO 20000 matrix https://info.advisera.com/27001academy/free-download/iso-27001-vs-iso-20000-matrix

This matrix shows the relationships between clauses of ISO 27001 and ISO 20000, and gives an overview of common requirements of these two standards with tips on how to fulfill them with as little documentation as possible.

This article will provide you further explanation about integrating management systems:
-  How to implement integrated management systems https://advisera.com/articles/how-to-implement-integrated-management-systems/

Environmental awareness

I will give my opinion on two levels. The first is more practical the second is more conceptual.

Let us go to the practical level: Before thinking on risks and opportunities I like to start with expected results. ISO 14001:2015 definition 3.2.10 and its Note 1 support viewing risk or opportunity as a deviation from the expected due to uncertainty. So, for energy use, for example, your organization may expect to become more efficient and reduce unitary consumption. What can go wrong and make you miss the target? 

For example, perhaps people are not motivated to adopt energy saving practices, this is a risk. 

For generation and disposal of waste your organization expects to minimize waste generation and waste contamination. What can go well and make you better than target? 

For example, one of the workers follows a practice that allows him/her to be much more efficient in the use of raw materials. Perhaps that practice can be generalized for all workers that program CNC cutting raw materials, this is an opportunity.

For example, you realize that the closer the waste bins are to place of generation of waste, the less contamination of wastes occur. Perhaps a new organization and distribution of waste bins can minimize waste 

Now, let us go to the conceptual level: when determining risks and opportunities in an environmental management system there are more than one way of doing it:

1. There are organizations that determine their environmental aspects and use a risk and opportunities assessment to determine its significant environmental aspects. (Please see the end of the second paragraph of Annex A.6.1.1 of ISO 14001:2015)

2. There are organizations that determine their environmental aspects evaluate them and determine the significant ones and use a risk and opportunities assessment to determine which ones need and action plan, and which ones need only to be monitored. For example, with your case, about habitat destruction, what can go wrong with your preventive measures system that can make the habitat suffer?

3. There are organizations that only apply the risk-based approach to the context part. In a certain way they are following the same approach as 1 without explicitly mentioning it.

The following material will provide you more information about aspects and impacts:

- Article - ISO 14001 risks and opportunities vs. environmental aspects - https://advisera.com/14001academy/blog/2016/06/06/iso-14001-risks-and-opportunities-vs-environmental-aspects/
- Free webinar - Free webinar - ISO 14001: Identification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
- Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
- Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
 

Context of the organization

In ISO 45001:2018 clause 4.1, context of the organization is understanding the internal and external issues that affect your ability to implement and maintain your OHSMS. Do you have an internal culture of safety or not? This would be an internal issue. A supplier notifying you that they are stopping production of a cleaning chemical you use (where the replacement is more hazardous) would be an external issue. This helps you to understand your organizational context; how it fits into the world around you.

You can learn more in this article: Defining the context of the organization according to ISO 45001, https://advisera.com/45001academy/blog/2016/02/03/defining-the-context-of-the-organization-according-to-iso-45001/