Anzacare ISO 13485 Certification

ISO 13485:2003 is the international quality system for manufacturing medical devices. Anzacare is the only manufacturer of bedwetting treatment alarms to have attained this certification and this shows our commitment to quality above everything else.

The ISO 13485:2003 certification shows without question that Anzacare is not just another company manufacturing bedwetting treatment alarms.
The essence of the ISO 13485:2003 certification is constant monitoring, evaluating, updating, learning and improving. This is what makes the difference between an ISO 13485: 2003 certified company and one that is not.

We are enormously proud to have attained this certification, a recognition of our years of work in developing our products and systems to the highest level.
As the only company manufacturing bedwetting alarms with this certification, then at Anzacare we can justifiably say that we have the best manufacturing system, and the best bedwetting treatment alarm system.

Have a look at the detail of what this actually means to you, the customer.

1.	ISO 13485:2003 is attained only when a manufacturer has a complete quality management system, and this has been examined and certified by an external, independent auditor (in Anzacare’s case the auditor is SGS). This quality management system contains all the following elements:
1.1	A Quality Manual and written procedures and work instructions that describe the correct way to carry out the design, development and production of the products of Anzacare.
1.2	Detailed records of the design and development are kept, e.g., a technical file is maintained which contains the independent laboratory safety tests carried out that show that the Anzacare products meet international standards of usability, safety and effectiveness (based on the International Standard ISO 14971:2007 which applies to medical devices).
1.3	Every completed DRI Sleeper® has a unique serial number, and the record of its production. This information and the test results and dispatch record are kept on file so that any issues can be traced to the production date, and even to the person who carried out the final testing.
2.	The Quality Manual, procedures and work instructions, and the records of the design, development and production are examined and audited by an external auditor (SGS). This is to provide independent confirmation that the Quality System meets international standards and is well-maintained.
2.1	To maintain certification this audit is carried out every year.
2.2	As well as the external audit, Anzacare is required to carry out its own internal quality audit using trained auditors on the Anzacare staff.
	Both these quality auditing procedures mean that all the processes and procedures of Anzacare are subjected to constant detailed inspection to make sure that every activity of the company is of highest quality and correctly carried out and recorded.
3.	Central to ISO 13485:2003 in particular is the customer, and customer relationships.
3.1	Being certified to ISO 13485:2003 demonstrates that Anzacare has been found to respond promptly to all customer matters, and to ensure, as far as is possible, customer satisfaction.
3.2	2 Records of customer communication are kept and audited by SGS to check that there is proper response to customer communication and any matters are resolved to the customers satisfaction.
3.3	Any product issues that may come from that communication are feed back into the production process. This is why, if you have any faulty item, the first step is that it will be replaced (if it is within the warranty period) and you will asked to return it for inspection by the factory. It is from returned items that we keep on learning and improving.
3.4	Anzacare surveys customers regularly for feedback, and this information is also feed back into development and production, and is regularly audited.
4.	The cost of this Quality System, our using highly qualified design engineers, and a local (rather than offshore) manufacturing facility with its own ISO 13485:2003 Quality System (Dynamic Controls, a company wholly owned by Invacare Corporation, USA), means that our products are not the cheapest . But cheapness is not what we aim for, we aim for the best product, built to the highest standard.
5.	Tests and standards that the DRI Sleepers® meet
	Part of ISO 13485:2003 is that our products are manufactured to meet international standards (see below) and to meet the requirements for North America (FDA, and Canada Medical Device Regulations) and for Europe, Asia, Australia/NZ and the Middle East. To ensure they meet these requirements they are tested by independent laboratories (UL International and EMC Technologies). Here is the list of test standards that are met by the DRI Sleepers®:
5.1	For the DRI Sleeper® Excel
5.1.1	Test of specification BS EN 60335-1:2002 “Safety of household and similar electrical appliances Part 1. General requirements.”
5.1.2	Tests to the specification IEC 60601-1-2: 2004. Medical electrical equipment. Part 1. General requirements for safety. Part 2. Collateral Standard: Electromagnetic compatibility requirements and tests. This report tests that the DRI Sleeper® excel does not give off any electromagnetic impulses, and that if it has some electromagnetic impulse applied to it then the operation of the DRI Sleeper® is not affected.
5.1.3	Tests to the specification EN 60601-1:2006 Medical Electrical equipment. Part 1: General requirements for basic safety and essential performance. This is a large series of tests that show that the DRI Sleeper® excel is safe electrically and safe in its physical design; that it has the correct labelling and instructions, and that it is robust and can withstand the rigors of use.
5.2	For the DRI Sleeper® Eclipse The tests in Numbers 1-6 blow show that the DRI Sleeper® eclipse meets the international requirements for radio frequency products that are used by people. The tests are very complex and the reports highly detailed, but any specific questions you have can be answered by contacting Anzacare info@anzacare.com or info@DRI-Sleeper.com Essentially they show that the DRI Sleeper® eclipse operates on the correct frequency, the radio signal is very low power, it is not affected by any other electromagnetic impulses nearby, it is electrically safe, and conforms to all the international requirements.
5.2.1	Test to: 47 Code of Federal Regulations. Part 15 Radio Frequency Devices Subpart B Unintentional Radiators Subpart C Intentional Radiators
5.2.2	Test to: AS/NZ 4268:2003 + Amendment 1:2005 Radio equipment and systems – short range devices – limits and methods of measurements
5.2.3	Test to: ETSI EN 301 489-3 V1.4.1, 2002 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for the Short Range Devices (SRD) operating on frequencies between 9kHz and 40 GHz
5.2.4	Test to: EN 50371:2002 Generic Standard to demonstrate the compliance of low power electronic and electrical apparatus with the basic restrictions related to human exposure of electromagnetic fields (10 MHz to 300 GHz) General Public.
5.2.5	Test to: EN 300 220-2 V2.1.2, 2007-06. Electromagnetic compatibility and Radio spectrum matters (ERM); Short range devices (SRD); Radio equipment to be used in the 25-1000 MHz frequency range with power levels up to 500 mW; Part 2: Harmonized EN covering essential requirements under Article 3.2 of the R & TTE Directive.
5.2.6	Test to: Industry Canada Radio Specification RSS-Gen, Issue 1, September 2005 and Rss-210, Issue 6, September 2005.
5.2.7	Test to: EN 60601-1:2006 Medical Electrical equipment. Part 1: General requirements for basic safety and essential performance. This is a series of tests that show that the DRI Sleeper® eclipse is safe electrically and safe in its physical design, that it has the correct labelling and instructions, and that it is robust and can withstand the rigors of use.