Terms of Sale

These Terms of Sale apply to every purchase on qualityworks.pro: the QMS document package and single procedures, ready-made products, trainings, courses, annual updates and support. Part A applies to every purchase. Part B has its own section for each type of product, with what you receive, how it is delivered, how you may use it and until when you may cancel. Part C applies to every purchase again. The Terms of Use and the Privacy Policy of the site also apply. When you place an order, you confirm that you have read these terms and that you accept them, on behalf of the company you order for or for yourself when you order privately.

## At a glance: until when you may cancel

- **QMS document package and single procedures:** a full refund until you submit the full intake (section 6).

- **Ready-made products:** a full refund until the download link is first opened (section 7).

- **Live trainings:** a full refund until 7 days before the training (section 8).

- **Recorded trainings:** a full refund until the link to the recording is first opened (section 8).

- **Courses:** a full refund until a lesson of the course is first opened after the purchase (section 9).

- **Certificate renewals:** a full refund until the renewal test is first opened (section 9).

- **Audit readiness report:** a full refund until the link to the report is first opened (section 10).

- **Quality Year:** a full refund until the first employee opens a training in the paid year (section 11).

- **Renewed annual updates:** you may stop renewing at any time, but a year that was paid is not refunded (section 6).

- **Support:** as stated when you order it (section 12).

# Part A: Every purchase

## 1. Who sells

The seller is qualityworks., owned by Sharon Resnick, a sole proprietor registered in Israel, 3 Bartonov Street, Petah Tikva, Israel 4952278. Email: sharon@qualityworks.pro. Phone: +972-53-531-5259.

## 2. Orders

You order through the order form on the product page or the course page. Each order receives a reference number (QW-####) that is used in all correspondence about it. The purchase is complete when the payment is received. If an order cannot be fulfilled, for example because a product is no longer offered, you are told and any payment is refunded in full.

Each product page and course page states what is included, the format and the regulations and standards it addresses.

## 3. Prices and payment

Prices are shown on the product page or the course page. Prices in Israeli shekels apply to customers in Israel and include VAT. Prices in US dollars apply to customers outside Israel and do not include VAT.

Payment is made by the means offered at the time of the order: payment details sent to you by email, or a secure payment page of our invoicing provider when one is offered. Payment card details are never collected or stored on the site. A tax invoice is issued for every payment, in the name and with the details you give in the order.

Discount codes apply only within their stated terms (products, dates, number of uses and, where stated, the people they are meant for). A code cannot be exchanged for cash or combined with another code. When more than one discount could apply to a course, such as a launch price, a circle. referral reward or a graduate discount, you receive the lowest single price. Discounts are not added together.

## 4. Cancellation and refunds: how it works

Each section in Part B states until when an order of that type may be cancelled with a full refund. After that point, the order cannot be cancelled or refunded. The site records when a download link, a recording or a report is first opened, when an employee first opens a Quality Year training and when a course lesson is first opened, and these records decide whether an order may still be cancelled.

To cancel, write to sharon@qualityworks.pro with the order reference. Refunds are made by the same means as the payment, within 14 days of the cancellation.

These terms are written mainly for companies. Where the Israeli Consumer Protection Law applies to a purchase, for example a private purchase, the rights it gives are not reduced by these terms.

## 5. Ownership

Everything sold on the site, including the documents, templates, trainings, courses and their content, remains the property of Sharon Resnick / qualityworks. and is protected by copyright. You receive a license to use it, not ownership. The license of each type of product is set out in its section in Part B.

# Part B: By type of product

## 6. QMS document package and single procedures

### 6.1 What you receive

The package is built for your company. You answer a short set of questions before the order (markets, product type, systems and optional parts), and the full intake after it. The package is then built from your answers: the procedures, forms, templates and trainings that apply to your company, with your company details in them. Single procedures come with their forms and templates and are built the same way.

### 6.2 Intake and delivery

Delivery begins once two things are in place: the payment is received and the full intake is submitted. The documents are delivered within 5 business days from the later of the two. Business days are Sunday to Thursday, excluding Israeli public holidays.

The documents are built from the answers you give. You are responsible for the accuracy and completeness of the intake. If you find a mistake in the details you entered, such as a company name or a role title, and tell us within 30 days of delivery, the package is built again once at no charge. A change to the scope of the intake after delivery, such as a new market, software in the device or production by a contract manufacturer, is paid. When it adds procedures, you pay for the procedures it adds: at the package rate if you purchased the package, or at the single procedure price if you purchased single procedures. If you purchased single procedures and move to the package, what you paid for documents is deducted from the package price. A change that adds no procedures but requires your documents to be built again costs the renewal price of the updates (section 6.6) and counts as a renewal. You order these changes from your customer card.

Files are delivered through a personal download link sent to the email address in the order. The link is valid for 14 days and for 10 downloads. If the link expires before you have saved the files, write to us and a new link is sent.

### 6.3 License

The license is granted to one company (one legal entity) for its own quality management system. It covers all sites of that company that operate under the same quality management system. A related company or affiliate with its own quality management system needs its own license.

Under the license, the company may:

- edit, adapt, translate and combine the documents for its own use;

- share them with its employees and with contractors who work on its quality management system;

- show them to its notified body, certification body, auditors, investigators and regulators.

The company may not:

- sell, give, publish or share the documents, or any part of them, outside the company;

- use them for another company, including as a consultant, contractor or service provider for clients;

- use them to create a product or service that competes with the qualityworks. shop.

The documents you purchased remain yours to use under this license whether or not you renew the annual updates.

### 6.4 Cancellation

You may cancel and receive a full refund until you submit the full intake. Once the intake is submitted, work on your documents begins and the order cannot be cancelled or refunded.

### 6.5 Errors in the documents

If you find an error in a document, such as a requirement stated incorrectly against the clause it cites, an internal reference that does not match, or a field that was built incorrectly from your intake, write to us with the order reference and the document number. The error is corrected and the corrected document is sent to you at no charge.

A request to change the content of a document to fit a choice of your company is not an error. It can be ordered as support (section 12).

### 6.6 Annual updates

Standards, regulations and guidance change, and the documents in the shop are updated when they do. Every purchase includes the updates of the documents you purchased, as a package or as single procedures, for one year from the date of payment. From the second year, you may renew the updates for one more year at a time, for 15% of the total you paid for those documents, and not less than the minimum renewal price shown in the shop. The documents are reviewed for changes at least twice a year, and an update is released when a change in a standard, regulation or guidance affects them.

When a document you purchased is updated during the year, you receive:

- the new version of the document, built again with your intake, ready to replace the version you received;

- a change notice that lists every change by section, with the reason for it and its source (the standard, regulation or guidance that changed);

- a comparison file that shows the changes against the version you received.

If your company has edited the document since it was delivered, you decide whether to replace it with the new version or to apply the listed changes to your own version.

Updates are sent to the email address in the order. The updates do not renew automatically. A reminder is sent 30 days and 7 days before the end of each year of updates, and you may renew them for another year. If you renew on or before the last day of a year of updates, the new year starts the day after it ends. If you renew later, the new year starts on the date of payment. Procedures you add during a year of updates are updated until the end of that year, and the renewal price is then calculated on the total you paid, including them.

You may stop renewing at any time. A year of updates that was paid is not refunded.

### 6.7 Your customer card

Your customer card, which you reach through the personal link in our emails, shows what you purchased, until when your updates are included and the renewal price. The card opens with a one-time code sent to an email address listed on it. You download your files, renew the updates and order added procedures from it.

## 7. Ready-made products

Ready-made products, such as templates, checklists, guides and kits, are delivered as files through a personal download link once the payment is received. Opening the link starts the download. The link is valid for 14 days and for 10 downloads.

The files are licensed to your company on the terms of section 6.3.

You may cancel and receive a full refund until the download link is first opened. After that, the order cannot be cancelled or refunded.

## 8. Trainings

### 8.1 Live trainings

The product page states the date, the length and how the training is held. Before the training, you receive the joining link at the email address in the order.

You may cancel and receive a full refund until 7 days before the training. After that, the payment is not refunded, but you may send another employee in your place or move to the next date of the same training.

### 8.2 Recorded trainings

A recorded training is delivered through a personal link to the recording, sent to the email address in the order. The product page states the access period.

You may cancel and receive a full refund until the link to the recording is first opened. After that, the order cannot be cancelled or refunded.

### 8.3 License

Trainings and their materials are licensed to your company on the terms of section 6.3. A recording may not be copied, re-recorded or shared outside the company.

## 9. Courses

### 9.1 What you receive

A course is an online course in English made of lessons with slides, explanations and check questions, practice tests, a final test and a certificate of completion. Where the course page lists course materials, you download them from the course page. The course page states the access period, the length, the pass mark and the number of attempts at the final test.

Two features of the courses are made with artificial intelligence and are offered for convenience only: the translation of a lesson's explanations and check questions into another language, and the recorded narration of the lessons. Their accuracy is not guaranteed. The English text is the course. The tests and the certificate are in English.

### 9.2 Access

You reach the course by signing in to circle. with the email address of the order, or with the email address a seat was given to. Joining circle. is free.

A company may buy seats for several learners in one order. Each seat is for one learner.

### 9.3 Certificate

The certificate of completion is issued by qualityworks. to a learner who passes the final test. It states that the learner completed the course and passed its test, and anyone can check it through its verification link. It is not an accredited certification and does not qualify anyone for a role required by a regulation. The course page states how long the certificate is valid.

Access to the course does not end when the certificate expires. Renewing the certificate is paid, at the renewal price shown on the course page. A renewal includes a summary of the changes made to the course since the previous certificate and a short renewal test with the same pass mark, and a certificate renewed before it expires continues from the end of the previous one. The course page shows the date of the course's last review.

### 9.4 License

Access to a course is personal to the learner who is enrolled, and the certificate is issued in the name of one learner only, to the learner who passed the test personally. The course content may not be copied, recorded, published or used to teach others. Course materials may be used within the learner's company for its own quality management system, on the terms of section 6.3.

### 9.5 Cancellation

You may cancel and receive a full refund until a lesson of the course is first opened after the purchase. In an order of several seats, the first lesson opened by any of its learners counts. After that, the order cannot be cancelled or refunded. A certificate renewal may be cancelled with a full refund until the renewal test is first opened.

## 10. Audit readiness report

The full report is built from the answers you gave in the audit readiness check. It opens when the payment is received, and the link is sent to the email address in the order. You may check again at no charge within 90 days of the payment and receive a new report that shows what was closed since.

The report is a self-assessment based on your answers. It is not an audit, a certification or a promise of the outcome of any audit or inspection. It is licensed to your company on the terms of section 6.3.

You may cancel and receive a full refund until the link to the report is first opened. After that, the order cannot be cancelled or refunded.

## 11. Quality Year

### 11.1 What you receive

A Quality Year subscription gives your company, for one year from the date the payment is received, access to the short Quality Year trainings for the number of employees in your plan, in Hebrew or in English for each employee. It includes the team page, where the manager of the subscription adds and removes employees and chooses their trainings, a certificate for each employee who passes all the trainings assigned to them in that year, and the yearly training table, which you can download.

### 11.2 Places

The number of places is the number you paid for: in the per-employee plan, the number of employees in the order (at least 3); in a plan "up to 10", "up to 25" or "up to 50" employees, that maximum. An order that is waiting for payment does not open any places. At any time, the number of active employees cannot be higher than the number of places. When you remove an employee, the place is free for another employee, and the records of the removed employee stay in the table. You may add places during the year by ordering them on the team page. Added places are priced for the rest of the current year, or as the difference to the plan that covers the new number of employees for the rest of the year, whichever is lower, and they open when that payment is received. Teams of more than 50 employees receive a quote.

### 11.3 Access and the end of the year

Each employee receives a personal link and signs in through circle. with their email address. Access to the trainings ends at the end of the paid year. If you renew before the end, the new year starts on the day after the current one ends, and the employees keep their access. If you do not renew, the access closes at the end of the year; the training records and certificates stay available to the manager of the subscription on the team page.

### 11.4 Certificates

A certificate is issued once a year for each employee who passes the final questions of all the trainings assigned to them in that year. It is a certificate of completion from qualityworks., with a public verification link. It is evidence of training for your records and is not an accredited qualification. The trainings teach principles that are common to medical device companies; training on your company's own procedures and work instructions remains your company's responsibility.

### 11.5 Who may use it

The subscription is for your company's own employees. Each place is for one named employee at a time, and the personal link of an employee may not be shared with others.

### 11.6 Cancellation

You may cancel and receive a full refund until the first employee opens a training in the paid year. After that, the year cannot be cancelled or refunded. Places added during the year are not refunded once paid. You may stop renewing at any time.

## 12. Support

Questions about an error in a document are handled under section 6.5 at no charge. Other support, such as help with implementing the documents, reviewing documents your company changed or preparing for an audit, is paid and is ordered separately. Applying the changes of an update to your company's own version of a document is also part of the paid support: you send us your current version, and we return it with the changes applied. What each support offer includes, its price, its validity and its cancellation terms are stated when you order it.

# Part C: Every purchase

## 13. Your responsibility

The documents, trainings and courses are a professional basis for a quality management system. Your company is responsible for adapting what it learns and receives to its devices, processes and organization, for implementing it, for training its employees and for its compliance with the regulations that apply to it. A purchase does not include a review of your quality management system, and no outcome of a certification, audit or inspection is guaranteed.

## 14. Limitation of liability

To the extent permitted by law, the total liability of qualityworks. for any claim related to a purchase is limited to the amount paid for that purchase. qualityworks. is not liable for indirect or consequential damages, including loss of profit, delay of a certification or market authorization, or a finding in an audit or inspection.

## 15. Personal information

The details you give in an order are used to process it, deliver it, send the updates and reminders described here and keep the records the law requires, as set out in the Privacy Policy.

## 16. Governing law and jurisdiction

These terms are governed by the laws of the State of Israel. Any dispute relating to them shall be subject to the exclusive jurisdiction of the competent courts in the Central District.

## 17. Changes to these terms

These terms may be updated from time to time. The version that applies to a purchase is the one published on the date of the order.

## 18. Contact

For any question about an order or these terms: sharon@qualityworks.pro | +972-53-531-5259