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QMS Turtle Diagram

If I have understood you correctly, the size of your subgroup will be 1. If you have only 1 piece, you cannot calculate standard deviation because there is no standard deviation if there is no more than 1 piece. You will need to have a sample of more than 30 to get valid statistical data.

Customer feedback

Yes you are right. If you receive return product for investigation that is customer property, and you need to handle it in accordance with the requirement 7.5.10 of ISO 13485:2016. 

ISO 9001 main clauses

I’m afraid I cannot help you. ISO 9001 is a standard for quality management systems, and a system is more than just the sum of its individual parts. So, all clauses of ISO 9001 are important because without some the whole would not work.

If an organization competes on innovation, clauses 8.2 and 8.3 are very important.

If an organization competes on service, clauses 8.2 and 8.5 are very important.

If an organization competes on price, clauses 8.4 and 8.5 are very important.

But the context, the interested parties, the process approach, the policy and objectives, the resources, the monitorization and improvement are also very important.

The following material will provide you more information about ISO 9001:

- Article – Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
- Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
 

Aspect VS Impact

How does an organization interact with the environment?
Through its activities and products or services.

An organization’s environmental aspects are all those elements that interact with the environment through its activities, products or services. For example, an organization during production consumes energy, generates waste, generates noise, can generate air emissions and/or wastewater discharges.

Environmental impacts are the changes, actual or potential, to the organization’s environment resulting from its environmental aspects.

ISO 14001:2015 clause 6.1.2 is about determining environmental aspects and impacts. I would say that determining environmental aspects and impacts is the cornerstone of any Environmental Management System.

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

- Article - 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
- Article - Environmental aspect identification and classification - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
- 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/

ISO 14001 and organization context

No, internal and external issues are determined independently. Relevant internal issues are a function of an organization’s past and strategy. Relevant external issues are a function of an organization’s macro and micro neighborhood and strategy.

The following material will provide you more information about context and interested parties:

- Article - Determining the context of the organization in ISO 14001 -https://advisera.com/14001academy/knowledgebase/determining-the-context-of-the-organization-in-iso-14001/
- White paper - Case study for ISO 14001:2015 transition in a construction company - https://info.advisera.com/14001academy/free-download/case-study-for-iso-14001-2015-transition-in-a-construction-company
- Enroll for free in the 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/

Structured Methodology for the implementation of QMS

First, just a note, I would follow a different approach. Instead of separating documentation design and its implementation, I recommend doing both simultaneously. The sooner the documentation meets reality, the sooner we start improving it and filling the development of the next documentation with information.

The following material will provide you more information about implementation:

- Article - Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- ISO 9001:2015 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-90012015-implementation-diagram
- Project Checklist for ISO 9001:2015 Implementation - https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation
- Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
- Enroll for free course – 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/

Recording evidence

Hi Rhand, thank you for your quick and helpful response! :-)

Security of suppliers

In the university I am seeing a subject "Systems Audit" where we see the ISO 27001 standard. Soon I have an exhibition on how to comply with the A.15 control and I have many doubts, I would like to have a little help from an expert.

For information about controls from section A.15 (Supplier relationships), I suggest you look at these articles:
- 6-step process for handling supplier security according to ISO 27001 https://advisera.com/27001academy/blog/2014/06/30/6-step-process-for-handling-supplier-security-according-to-iso-27001/
- Which security clauses to use for supplier agreements? https://advisera.com/27001academy/blog/2017/06/19/which-security-clauses-to-use-for-supplier-agreements/
- How to perform an ISO 27001 second-party audit of an outsourced supplier https://advisera.com/27001academy/blog/2017/10/10/how-to-perform-an-iso-27001-second-party-audit-of-an-outsourced-supplier/

This material will also help you regarding controls from section A.15:
-  ISO 27001:2013 Internal Auditor Course https://advisera.com/training/iso-27001-internal-auditor-course/

Video tutorial content

1. The video "How to Write ISO 27001 Procedure for Corrective and Preventive Actions" talks about preventive actions. I cannot find this paragraph in the template.

I'm sorry about this problem - this particular video was made for earlier revision of the standard, and you can disregard the part about preventive actions.

If you find any other differences between any video tutorial and the templates, please consider the templates, because they are up to date to the current version of the standard.

ISO 27001:2013 does not require preventive actions anymore. These are treated as part of clause 6.1 (Actions to address risks and opportunities), which does not require these actions to be documented.

If you still feel you need more information about this topic, you can schedule a meeting with one of our consultants. To schedule a meeting, please access this link: https://advisera.com/27001academy/consultation/

2. The video talks about compatibility with ISO 9001 and ISO 14001 - please provide the applicable clauses in the template, thanks.

For information about clauses compatibility between ISO 27001 and ISO 9001, please see this free downloadable material:
- ISO 27001 vs. ISO 9001 matrix https://info.advisera.com/9001academy/free-download/iso-9001-2015-vs-iso-27001-2013-matrix

A similar approach can be used to map compatible clauses between ISO 27001 and ISO 14001.

These articles 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/
- Using ISO 9001 for implementing ISO 27001 https://advisera.com/27001academy/blog/2010/03/08/using-iso-9001-for-implementing-iso-27001/

Self Declaration to 17025

An ISO 1725 accreditation body must first assess the competency and compliance of the laboratory to the ISO/IEC 17025 standard requirements before a calibration or testing laboratory can declare that they are meeting the requirements of the ISO/IEC 17025 standard for services offered. After assessment, the accreditation body issues a Certificate of Accreditation for the accredited laboratory, which will be published on the accreditation body’s website. This includes the Scope of Accreditation – a list of specific calibration and measurement tests that the accreditation body has assessed the laboratory to be technically competent to perform against the ISO 17025 standard. This becomes the evidence for a declaration by a laboratory.

For more information on the process please read the following articles: 

• Project Plan for ISO/IEC 17025 implementation https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation
• Checklist of ISO 17025 implementation steps - https://advisera.com/17025academy/blog/2019/08/28/checklist-of-iso-17025-implementation-steps/