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Disposal of sensitive data

Please note that ISO 27001 does not provide technical guidance on how to perform data disposal. 

For technical guidance, you should consider these references:

• ISO/IEC 27040 Information technology — Security techniques — Storage security https://www.iso.org/obp/ui/#iso:std:iso-iec:27040:ed-1:v1:en
• NIST 800-88 - Guidelines for Media Sanitization https://csrc.nist.gov/publications/detail/sp/800-88/rev-1/final

These articles can also help:

• Secure equipment and media disposal according to ISO 27001 https://advisera.com/27001academy/blog/2015/12/07/secure-equipmentand-media-disposal-according-to-iso-27001/
• 5 practical tips for media disposal according to ISO 27001 https://advisera.com/27001academy/blog/2018/10/22/5-practical-tips-for-media-disposal-according-to-iso-27001/

Cleaning validation SOP for orthopedic medical device

what I am looking for Cleaning validation SOP for orthopedic medical device"

ISO 45001 implementation minimal requirements

There is no set of “minimum requirements” to implement ISO 45001, every requirement in the standard (identified with the work “shall”) needs to be addressed. However, the requirements describe what needs to be done, but do not give details on how to implement them, because they need to be tailored to your organization. For instance,  ISO 45001 does not tell you what OH&S legal requirements you need to meet (since this will be different all over the world), but requires that you have a process to identify your legal requirements, keep up to date with changes to these requirements, and confirm that you meet the requirements.

You can learn more about the requirements in the whitepaper: Clause-by-clause explanation of ISO 45001:2018, https://info.advisera.com/45001academy/free-download/clause-by-clause-explanation-of-iso-45001

ISO 14001 Risk Register Preparation

You can prepare a table where you list:

• risks,
• sources,
• measure of severity,
• measure of probability,
• measure of significance,
• actions to be implemented,
• responsibilities,
• main resources needed,
• time frame.
   

You can find more information below:

• ISO 14001 risks and opportunities vs. environmental aspects - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
• Risks and opportunities in ISO 14001:2015 – What they are and why they are important - https://advisera.com/14001academy/blog/2016/03/07/risks-and-opportunities-in-iso-140012015-what-they-are-and-why-they-are-important/
• 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/
• ISO 14001 document template: Procedure for Identification and Evaluation of Environmental Aspects and Risks - https://advisera.com/14001academy/documentation/procedure-for-identification-and-evaluation-of-environmental-aspects/
• Enroll for free in this course – ISO 14001:2015 Lead Auditor Course - https://advisera.com/training/iso-14001-lead-auditor-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/
   

GDPR Implementation Inquiry

"We have an inquiry regarding the GDPR implementation, we are a software company that develops a software solutions to  a customer X at Europe ; the  software solutions are carrying personal information for X’s employees so we are a processor.
Internal systems developed and maintained by my company  for other customers that have EU citizen employees should be GDPR compliant and in this case it should be secure by design and data should be secured at rest considering there is no agreement between the client and ourselves for applying GDPR requirements on the system ..please confirm?

You are a data processor under GDPR because you are processing personal data on behalf of your Client. You need a data processor appointment agreement to comply with obligations listed in Article 28 GDPR. It helps you to demonstrate accountability to GDPR principles in case of controls by Data Protection Authorities. 

We developed the template of the Agreement to use with your Clients applying GDPR:
EU GDPR document template: Supplier Data Processing Agreement https://advisera.com/eugdpracademy/documentation/supplier-data-processing-agreement/

You can also find more information here:

• Full text of GDPR: https://advisera.com/eugdpracademy/gdpr/
• EU GDPR controller vs. processor – What are the differences? https://advisera.com/eugdpracademy/knowledgebase/eu-gdpr-controller-vs-processor-what-are-the-differences/

Regarding personal rights, are these rights applied on employees as they are EU citizens in the way that is compliant with business rules and data retention policies, for example if the employee left the company and wants his data to be deleted, in this case the company should reply within 1 month that according to the business needs and regulations, his data will be retained for 5 years for example and after these 5 years ha may ask for a data deletion confirmation, is that right? We need to know what are the employee rights here and what to be applied at our systems? 

Being a data processor under GDPR you need to guarantee data subjects’ rights in your system. However, it should be the data controller to ensure that you comply with GDPR requirements through the Data Processing Agreement.

This happens because data subjects shall exercise their rights in front of the data controller and you – as a data processor – will be jointly responsible. Keep in mind that retention periods may vary under national legislation implementing GDPR requirements (I.e. in Italy bookkeeping legislation requires a company to store documents for 10 years) so you need to check it with your Client.

The employee rights are those listed from Article 15 to 22 GDPR:

• Right of access
• Right of rectification
• Right of erasure (Right to be forgotten)
• Right to restriction of processing
• Right to data portability
• Right to lodge a complaint to a Data Protection Authority
• Right to object
• Right to ask for human control in case of automated individual decision-making

Here you can find more information:

• Full text of GDPR: https://advisera.com/eugdpracademy/gdpr/
• Data subject rights according to GDPR: https://advisera.com/eugdpracademy/knowledgebase/8-data-subject-rights-according-to-gdpr//

You can consider enrolling in our free EU GDPR Foundations Course
EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

ISO 9001 and product added value

First, attention: ISO 9001:2015 is not about product or processes, it is about the management system.

I belong to a group of people that think that value is not added to a product but something that emerges in the mind of a customer. Value is in the eyes of the beholder.

So, I made this figure to help me share how I see your challenge:

Your organization was certified and now wants to increase prices to previous customers because now it is certified. That is quadrant 1 on the figure, it is what I call arm wrestling. You cannot do it competition will not allow it.

Your organization was certified and now can access previous markets where ISO 9001 acts as an entry barrier. That is quadrant 2 on the figure, your organization has to find new customers that could value more your product and services.

Another alternative stands over developing a new offer, a new product, a better service, to the same or different customers, quadrants 3 and 4.

You can find more information below:

• 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/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

ISO 9001 compliance in a mining company

When I’m in that situation I follow this technique:

So, I list the major benefits that can pull top management to make that decision. I also list problems, organizational pain, that can push top management to make that decision. About the resources needed that will depend from organization to organization, but for one with 33 000 employees I believe is quite affordable.

You can find more information about ISO 9001 implementation below:

• Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
• How to budget an ISO 9001 implementation project - https://info.advisera.com/9001academy/free-download/how-to-budget-an-iso-9001-implementation-project?utm_source=script-for-iso-9001-lead-implementer-course&utm_medium=downloaded-content&utm_content=lang-en&utm_campaign=free-downloads-9001
• 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/ may be useful
• 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 and itemized inventory as a requirement

If you include that requirement as an explicit specification of your orders and if your supplier accepts that requirement you can expect and demand compliance with that requirement. Let’s see what ISO 9001 requires from a supplier receiving an order from a customer, you:

Clause 8.2.2 is about receiving an order, or a request for a quotation from a potential client. Your ISO 9001 certified supplier wants to be sure about what is that the customer, you, want, it can be a standard product from their warehouse, but that is not enough. They need to know quantities, delivery date, any restrictions imposed by law, and even restrictions imposed by their own organization. For example, they may not deliver an order to a certain country, or to a PO box address.

Clause 8.2.3 is about preparing to make a promise to the client, to you. The supplier already knows what the requirements and needs are, but before making a commitment, they must be sure they have the resources to comply.
Can their organization comply with explicit requirements from the client, from you, for example, can they deliver the amount required on the requested date? Can their product really comply with a performance feature required by you?
They know more about the product or service and conditions of use than any client. They may know about some implicit requirements not mentioned by you but required for the effective performance of the product. Is their organization in condition to comply with those implicit requirements?
Can they comply with legislation and regulation applicable?
Can they provide the product within the organization’s own internal rules? For example, will they accept a 200-days interval for payment according to the client requirements, when their organization’s internal rules are only 20 days?

You can find more information below.

• Clause-by-clause explanation of ISO 9001:2015 - https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015
• 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/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/