Regulatory conformity and change notice policy ... - Elcam Medical
Regulatory conformity and change notice policy ... - Elcam Medical
Regulatory conformity and change notice policy ... - Elcam Medical
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<strong>Regulatory</strong> <strong>conformity</strong> <strong>and</strong> <strong>change</strong> <strong>notice</strong> <strong>policy</strong>.<br />
Quality management system<br />
<strong>Elcam</strong> <strong>Medical</strong> maintains a quality management system in accordance with the following:<br />
I. ISO 13485 (2003) – Certified by the St<strong>and</strong>ards Institution of Israel (attached in page 2).<br />
II.<br />
Annex II of the European Directive 93/42/EEC – Certified by Notified Body 0483 (MDC,<br />
Germany) (attached in page 3).<br />
III. FDA Quality System Regulation: Title 21 Code of Federal Regulations Part 820<br />
effective from 1997.<br />
<strong>Elcam</strong> <strong>Medical</strong> shall notify its customers regarding any significant <strong>change</strong>s to its quality management<br />
system 24 months prior to any such modification.<br />
<strong>Elcam</strong> <strong>Medical</strong> will investigate any complaints filed by its customers <strong>and</strong> initiate corrective action if<br />
deemed necessary by <strong>Elcam</strong> <strong>Medical</strong>. <strong>Elcam</strong> will notify the customer of any significant product<br />
related risk that may arise or become known.<br />
Record keeping <strong>and</strong> record availability<br />
<strong>Elcam</strong> <strong>Medical</strong> retains production records for 6 years from the date of production. Production records<br />
are available for customer or notified body review upon cause <strong>and</strong> request, with the exception of<br />
records that contain commercial secrets <strong>and</strong>/or proprietary information, such as manufacturing <strong>and</strong><br />
testing know-how.<br />
Audits <strong>and</strong> visits<br />
Customers (or their notified body) are welcome to audit <strong>and</strong> visit most of <strong>Elcam</strong> <strong>Medical</strong>’s facilities at<br />
any time upon prior coordination.<br />
Change <strong>notice</strong> <strong>policy</strong><br />
<strong>Elcam</strong> <strong>Medical</strong> will notify its customers of any of the following <strong>change</strong>s:<br />
1. Composition <strong>and</strong> source of raw material.<br />
2. Product design that affects the function of the device or external dimensions (including<br />
dimensions of mating surfaces with external devices).<br />
3. Acceptance criteria.<br />
4. Location of manufacturing facility.<br />
5. Manufacturing process other than:<br />
a. Changes within working window of a process.<br />
b. New tooling (like new mold or new assembly machine) utilizing the same<br />
technology.<br />
c. Testing methods.<br />
<strong>Elcam</strong> <strong>Medical</strong> is obliged to supply products that meet customer specification. If a <strong>change</strong> reflects on<br />
customer’s product specification, then <strong>Elcam</strong> <strong>Medical</strong>'s obligation to meet customer's specifications<br />
shall pertain to the revised specifications as amended by the customer to incorporate the <strong>change</strong>, <strong>and</strong><br />
accepted by <strong>Elcam</strong> <strong>Medical</strong>.<br />
Notice of scheduled <strong>change</strong>s will be given no less than 4 months prior to their implementation.<br />
To dispel all doubt, the above stated shall not apply <strong>and</strong>/or pertain to any immediate <strong>change</strong>s required,<br />
due to requisite safety measures or circumstances beyond the reasonable control of <strong>Elcam</strong> <strong>Medical</strong>.<br />
Please contact Quality manager if additional information is required.<br />
Sincerely,<br />
Shay Shaham- Quality manager<br />
September 16, 2009<br />
<strong>Elcam</strong> <strong>Medical</strong><br />
BarAm 13860, Israel<br />
Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il<br />
www.elcam-medical.com
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<strong>Elcam</strong> <strong>Medical</strong><br />
BarAm 13860, Israel<br />
Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il<br />
www.elcam-medical.com
Page 3 of 3<br />
<strong>Elcam</strong> <strong>Medical</strong><br />
BarAm 13860, Israel<br />
Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il<br />
www.elcam-medical.com
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