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Information on product and packaging labels

Yes, I agree that product label does not contain only UDI information. However, there is no requirement both in ISO 13485:2016 and in MDR 2017/745 to have a procedure for labelling. 

Information that need to be on the label and Instruction of use are descibed in MDR 2017/745 in General safety and perfromence requirements, Annex I – in Chapter III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE. - https://advisera.com/13485academy/mdr/general-requirements

In Article 7 Claims you can see information how clains for intended use are supposed to be stated. https://advisera.com/13485academy/mdr/claims/

ISO 9001 internal audit in e-Commerce industry

How to do internal audit of ISO 9001 ? I need case studies in E-Commerce industry

Is 13485 Mandatory for making IR Thermometer?

1. Is 13485 Mandatory or ISO 9001 With the scope covering IR Thermometer enough?

All medical devices must be in compliance with harmonized standards. In MDR, in Article 10 General obligations of manufacturers, it is stated that the manufacturer must have implemented a quality management system. The list of harmonized standards is published by Official Jurnal of the European Union. On this list, ISO 13485:2016 is the only standard covering quality management system, therefore it is expected for manufacturers to have implemented ISO 13485:2016.

For more data, please see the following links:

• EU MDR Article 8 – Use of harmonized standards https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
• What are EU harmonized standards? - https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/
• Link to the harmonized standards published by EU https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

2. Is 13485 Certification mandatory to obtain the CE Mark?

No, neither in MDD (93/42/EEC) nor MDR (2017/7450), there is no direct requirement that manufacturers need to be certified according to the ISO 13485:2016. The requirement is only to have implemented a quality management system as is explained in the previous answer.

If you need any help for the implementation of the ISO 13485:2016, these materials can help:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

You can see our ISO 13485:2016 Documentation toolkit on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

ISO 9001 Generating Supplier Contracting Process

How does the process start? With the need for contracting a supplier? Who has that initial need?

How does the process end? With a new contracted supplier?

What are the main steps from start-to-end?

Identifying the need?

Determining the requirements for the supply?

Determining the requirements for the supplier?

Contacting potential suppliers

Receive and evaluate proposals?

Visit and or audit them?

Signing a contract?

Then write the process sequence and responsibilities and authorities.

The following material can provide more information:

• ISO 9001 document template: Procedure for Purchasing and Evaluation of Suppliers - https://advisera.com/9001academy/documentation/procedure-purchasing-evaluation-suppliers/
• How to evaluate supplier performance according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/
• 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/
   

ISO 9001 SME challenge

Unfortunately, Advisera has no case study about that relationship. However, I would like to invite you to a thought exercise.

Productivity is a ratio. So, one can improve productivity either by increasing the numerator (higher value added, higher margins), or either by decreasing the denominator (reducing costs, improving efficiency)?

Consider this scenario as an example:

Now, for each process, determine the functions that participate and what activities contribute the most to productivity and design a job description with the relevant competence criteria. Please check this technique presented on this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ - particularly slides 13-15.

The following material will provide you more information about competency and the process approach:

• How to ensure competence and awareness in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-ensure-competence-and-awareness-in-iso-90012015/
• 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/ - where I extensively use the process approach.
   

ISO 14001 Multiple sites merging under one manual

Thank you.  Much appreciate your help

ISO 9001 Sales office under the scope

Your company interacts with clients according to ISO 9001:2015 clause 8.2 and that clause cannot be excluded. If clause 8.2 is done by Sales offices, it cannot be excluded from scope.

The following material will provide you more information about exclusions:

• 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/

ISO 9001 Managing an ISO 9001 compliant system

For documents that are relevant to the quality management system. Normally, organizations use stamps like:

• Controlled copy (after approval)
• Uncontrolled copy (for example, when a document is given to an outsider for information purposes)
• Obsolete (when the document is no longer current but the organization decides to keep a copy for historical purposes)
   

The following material will provide you more information about documents:

• How to set up document approval/withdrawal within your QMS based on ISO 9001:2015 - https://advisera.com/9001academy/blog/2016/04/12/how-to-set-up-document-approvalwithdrawal-within-your-qms-based-on-iso-90012015/
• 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/

Question about ISO 27018 certification

Thank you for the reply. That clears it up then. 

Aligning business strategy to ISMS

In fact, the most common situation is the other way around (align ISMS to business strategy), and to do that you basically need to take business objectives and strategies into account when defining the ISMS objectives and scope.

For example, if e-commerce is an important part of the business, and the ISMS objectives and scope do not include e-commerce, then the ISMS is not aligned to the business.

Another example, if customer information is important to the business and the ISMS scope includes customer information, and there is a clear ISMS objective related to it (e.g., reduce the occurrence of a customer data breach, or comply with GDPR), then the ISMS is aligned with the business.

This article will provide you a further explanation about aligning ISMS to business strategy:

• Aligning information security with the strategic direction of a company according to ISO 27001 https://advisera.com/27001academy/blog/2017/02/20/strategic-direction-of-a-company-according-to-iso-27001/