Search results

Integrating IATF 16949 with ISO 9001

IATF 16949 has higher requirements than ISO 9001. We can consider ISO 9001 as a standard with basic requirements and IATF 16949 would be the standard with advanced requirements.

Certification for ISO 9001 is good as a starting point for the development of the IATF 16949 system.

For more details please read the article: “ISO 9001 vs ISO/TS 16949” https://advisera.com/9001academy/blog/2014/10/01/iso-9001-vs-isots-16949/

Upgrading the Project Quality Plan to ISO 9001:2015?

First, is your organization certified or wanting to be certified? If yes, certification body auditors may raise a nonconformity in the next surveillance audit or certification audit. If no, is there any particular request from your customer? Can your organization negotiate with the customer the maintenance of the status-quo or small changes?

If you have to update the documentation, I recommend starting with a Gap Analysis to determine what is different, what is missing, in the transition from 2008 version into the 2015 version. I believe that there are not so many differences in terms of operations. Consider clause 6.3 of ISO 9001:2015, about how to make changes in your quality management system without introducing disruption and chaos.

The following material will provide you more information about the transition:

- Case study for ISO 9001:2015 transition in a construction company - https://info.advisera.com/hubfs/9001Academy/9001Academy_FreeDownloads/Case_study_for_ISO_9001_2015_transition_in_construction_company_EN.pdf
- Free ISO 9001:2015 Gap Analysis Tool - https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- Free webinar on demand – ISO 9001:2015 - How to make the transition from ISO 9001:2008 - https://advisera.com/9001academy/webinar/iso-90012015-how-to-make-the-transition-from-iso-90012008-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/

Exclusión del requisito de diseño

Si ustedes aunque fabrican ese kit y lo diseñan sólo van a certificar los procesos de reparación y venta entiendo que la cláusula 8.3 de diseño y desaarrollo puede ser excluida. Sin embargo, tienen que contemplar la posibilidad de si existe un mínimo trabajo de diseño y desarrollo durante la reparación y en ese caso debería de incluir la cláusula. Así mismo la venta puede estar sujeta al requisito de diseño y desarrollo, por ejemplo si su organización es la responsable del transporte de los productos que vende y tiene que diseñar la ruta del transporte, entonces tendría que incluir la cláusula de diseño y desarollo en el alcance del SGC. 

Para más información sobre la exclusión de la cláusula de diseño y desarrollo en ISO 9001:2015 vea los siguientes materiales:

- Artículo - 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/
- Webinar gratuito - 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/
- Inscríbase gratis en este curso -  Curso de Fundamentos de la nroma ISO 9001:2015 - https://advisera.com/es/formacion/curso-fundamentos-iso-9001/
- Libro – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Background report

After ensuring that you have established the identity of the requestor you have one month to provide an answer.

In your case, you can need to provide the requested information using the same channel you received the request e. g email.

The full process is described in the Data Subject Access Request Procedure in the Toolkit you purchased as well as in this EU GDPR Data Subject Access Request Flowchart (https://info.advisera.com/eugdpracademy/free-download/eu-gdpr-data-subject-access-request-flowchart)

Template content - Access control policy

Please note that the original English text is "When allocating privileges the person responsible must take into account business and security requirements for access (defined in risk assessment), ..."

Considering this text, business and security requirements for access are not defined in the risk assessment. The risk assessment only provides additional information that must be considered when defining such accesses. An example of business requirement for access is remote access to some roles (e.g., sales staff, remote developers, etc.)

Starting ISMS implementation

Unfortunately, these templates are available only in English. To see the free downloadable material we have in German, please access this link: https://advisera.com/27001academy/de/kostenlose-downloads/

Top Management Audit

I cannot give a checklist, but I can provide you with the raw materials to develop your own checklist. You can start by listing all the topics in ISO 9001:2015 (you can see that for ISO 14001:2915 they are almost the same) that can be related with top management. The following article - How to perform an ISO 9001 audit of top management without fear - https://advisera.com/9001academy/blog/2019/05/15/iso-9001-top-management-audit-how-to-perform-it-successfully/ give you a good start.

You can get much more detailed information in the following links:

- Article - ISO 9001 Audit Checklist - https://advisera.com/9001academy/knowledgebase/iso-9001-audit-checklist/
- Article – about the checklist technique - ISO 9001 audit checklist for laboratory - https://advisera.com/9001academy/blog/2018/09/04/iso-9001-audit-checklist-for-laboratory/
- Enroll for free - ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-9001-internal-auditor-course/
- book – ISO Internal Audit: A Plain English Guide - https://advisera.com/books/iso-internal-audit-plain-english-guide/

Integrating ISO 13485 and ISO 27001 & GDPR

You can use the following documents for both ISO 13485 and ISO 27001 because they are practically the same:
- Internal audit procedure
- Procedure for document and record control
- Corrective action procedure

All the other documents are different because they fulfill requirements specific to each standard, so these other documents cannot be integrated.

This way you can have an integrated system and reduce your administrative effort.

Development of an ISMS

For development of an ISMS compliant with ISO 27001, the leading ISO standard for information security management, I suggest to take a look at the free demo of our ISO 27001 Documentation toolkit at this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/

These articles will provide you further explanation about ISMS compliant with ISO 27001:
- What is ISO 27001 https://advisera.com/27001academy/what-is-iso-27001/
- ISO 27001 implementation checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/
- Where to start from with ISO 27001 https://advisera.com/27001academy/knowledgebase/iso-27001-where-to-start-most-important-materials/

These materials will also help you regarding ISMS compliant with ISO 27001:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

Handling and storing of reference accessories of Multi-product calibrator

From your question, I assume you are asking how to include such items in your existing equipment procedure, as you may not have covered all the components and accessories. To include the accessories of your Multi-product calibrator, you can reference documented criteria as guided by the manufacturer of the components in the product manual. If not specified, simply reference best practices for a particular item, for example “roll electrical cable to avoid kinks, and secure with a suitable tie”. Remember, a record is mandatory, so create a checklist with the required acceptance criteria, listing for example “cables were coiled”, “transported in a case”, “no visible kinks or damage evident”. When using the equipment, use the checklist to acknowledge that the criteria were met and retain your record as evidence.

For an overview of ISO 17025:2017 requirements, please read the following article:

What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/