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HDS

Can an HDS be done between countries?
I mean can we store medical data in a country and use the date in another country?

Implementing QMS with non-mandatory documents

You can use nonmandatory required documents for your QMS, but you must use the mandatory required documents.

Using more or less nonmandatory documents in a QMS should be a function of the QMS complexity and people experience and competence. Please check ISO 9001:2015 clause 4.4.2.

The following material will provide you more information about documentation:

- How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
- ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/

- Free webinar on demand – How to use a Documentation Toolkit for the implementation of ISO 9001 - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-free-webinar-on-demand/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

Customer specific requirement on Supplier Quality Assurance Manual

SQAM is a TOYOTA customer specific requirement and there are different sections in SQAM. Normally you can dowlload from Toyota Portal if you supply to Toyota and have a portal access. SQAM has total of 33 sections and can only be download from the Toyota portal.

All these symbols are from SQAM book,section 11 Quality Problem Reporting and Section 33 Supplier Quality Assurance Manual of Toyota customer requirements.

ISO 9001 quality documentation

Below you will find links for: how to structure the quality management system documentation – what kind of documents and their purpose; the mandatory documents required by ISO 9001:2015; Advisera’s ISO 9001:2015 Documentation Toolkit.

The following material will provide you more information about documentation:

- How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
- ISO 9001:2015 Documentation Toolkit - https://advisera.com/9001academy/iso-9001-documentation-toolkit/

- Free webinar on demand – How to use a Documentation Toolkit for the implementation of ISO 9001 - https://advisera.com/9001academy/webinar/how-to-use-a-documentation-toolkit-for-the-implementation-of-iso-9001-free-webinar-on-demand/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/

Applicable regulation in aftermarket

Regarding regulation, you’ll need some background knowledge, since standards, regulations, and practices in North America differ fundamentally from those in markets using the IEC standards. If you are interested in applicable standards, you can check some of the standards for Valve Actuators (e.g. ISO 22153:2020 Electric actuators for industrial valves — General requirements).

Regrading legal responsibility, you should also find legal representatives for both countries of the manufacturing and county of the aftermarket. Answer for accidents or injuries of end-user are main concerns, and besides the legal part, you should have deep analysis in your system, so you are able to recognize all places of potential injuries your product can cause. In this way, you can find places for improvement and level up product safety.

Mobile device

Your assumption is correct, you can include a laptop in the mobile device category.

Broadly speaking, a mobile device is any device that can be easily moved from one location to another. Over time, this category has expanded to include cell phones, laptops, smartphones, smartwatches, and other portable devices.

For more information, see:

• How to write an easy-to-use BYOD policy compliant with ISO 27001https://advisera.com/27001academy/blog/2015/09/07/how-to-write-an-easy-to-use-byod-policy-compliant-with-iso-27001/

Difference between ISO 27001:2013 and ISO 27000:2016

The differences are:

• ISO 27001 provides the requirements for the planning, implementation, operation, and improvement of an Information Security Management System (ISMS). This one is the standard to be used as a reference for certification.
• ISO 27000 provides the terms and definitions commonly used in the ISO 27001 family of standards. This is a supporting standard to make an understanding of the ISO 27001 family of standards easier.

This article will provide you a further explanation about ISO 27001:

• What is ISO 27001 https://advisera.com/27001academy/what-is-iso-27001/

Separate organizations in one location

Yes, you can. Two different organizations with different legal existence, even in the same location can have different ISO 9001:2015 certificates.

Even two organizations belonging to the same entity can have different certificates if each certificate is about a different scope.

You can find more information about scope below:

- How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- What clauses can be excluded in ISO 9001:2015? https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
- 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/

Toolkit content

No, since each company has its own coding system, we have left our clients to insert their own codes into the documents. Of course, the policies and procedures in our toolkit make cross references to other documents using their names, but you can insert also the codes as well if you see this as necessary.

For more details please read the following article: Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/

Gestión del cambio

Los cambios que debe tener en cuenta son aquellos que pueden afectar a su sistema de gestión de calidad y estos cambios pueden tener diferentes orígenes: pueden surgir durante las reuniones de gestión de riesgos, también de las no conformidades detectadas, o de las encuestas de satisfacción del cliente. Así mismo, pueden provenir de cambios en alguna normativa o requisito legal que afecte a su empresa, o de otros cambios en los requisitos del producto o servicio que ofrece. Estos cambios deben ser registrados y planificados según la norma ISO 9001:2015

Para más información sobre la gestión de los cambios en ISO 9001:2015, vea los siguientes materiales: 

- Artículo - QMS change management in 7 steps: https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/

- Libro - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

- Curso de Fundamentos ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/