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Vendor Audit

According to the ISO 13485:2016, requirement 7.4.1 Purchasing process, it is not mandatory to audit vendors which are critical. 

This requirement states that organizations must establish criteria for the evaluation and selection of suppliers. These criteria must be based on the supplier’s ability to provide certain products; on the performance of the supplier (e.g. delivery date, minimum quantity for order and similar); and effect of the purchased product on the quality of the medical device. So, what that criteria will be it is up to the manufacturer to take into consideration the risk associated with the medical device. 

Also, this requirement state that organization must plan the monitoring and re-evaluation of suppliers. How often will it be done, will there be an audit or not, it is up to the manufacturer. 

For more information please read the following articles: 

How can ISO 13485 clause 7.4, Purchasing, enhance procurement? https://advisera.com/13485academy/blog/2018/04/18/how-can-iso-13485-clause-7-4-purchasing-enhance-procurement/

First-, Second- & Third-Party Audits for medical device manufacturers & suppliershttps://advisera.com/13485academy/knowledgebase/first-second-third-party-audits-for-medical-device-manufacturers-suppliers/

GDPR Articles for the recruitment

Recruitment requires to comply with article 5 GDPR which applies to all data processing.

First of all, you must inform individuals about data processing with a privacy notice. The purposes of processing can be seen in recruitment and the legal ground of processing can be either consent (if you collect consent from candidates) or contract (where the prenegotiated phase is included).

You should also determine the data retention policy determining how long will you keep data (CVs, and other personal information) from candidates and keep track of consent giving the chance to candidates to modify the provided data.

You can find more information in this article:

• How the GDPR could impact your HR department: https://advisera.com/eugdpracademy/blog/2018/02/22/how-the-gdpr-could-impact-your-hr-department/
• Is consent needed? Six legal bases to process data according to GDPR: https://advisera.com/eugdpracademy/knowledgebase/is-consent-needed-six-legal-bases-to-process-data-according-to-gdpr/

You can also find some useful information in our free training EU GDPR Foundations course: https://advisera.com/training/eu-gdpr-foundations-course//

Here you can find our template of Employee data protection policy: https://advisera.com/eugdpracademy/documentation/employee-personal-data-protection-policy/

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/