ISO Quality standard 9001:2000

We are committed to providing the highest quality products and services to reduce drug related harm.

The ISO 9001:2000 quality standard is an internationally recognised independently audited measure of quality, that gives customers a guarantee that an organisation has the internal systems necessary to deliver constantly improving products and services.

We have been registered since 2005, and our annual independent audit has always been very positive.

"An exemplary well documented system with design and content to a high standard"

5th ISO assessment: October 2008
Our 2008 assessment was again extremely positive, with (as always) no 'non-compliances' found in any of our proceedures or quality systems.

The auditors' report said:

"Exchange Supplies is an exceedingly well run company. The Quality Management System was well designed, and the procedures contained therein are followed and used as a management tool.

An in-depth audit revealed no findings worthy of note.

Employees have been well trained, and documented procedures are being followed. The systems were seen to be maintained and improved in accordance with the requirements of ISO 9001:2000, and continued registration is recommended.

2007 assessment
Since our last assessment we have become a licenced pharmaceutical wholesale dealer, and we included all the proceedures relating to the proper storage and distribution of medicines in the scope of the inspection.This makes the achievment of continuted egistration, with only one minor non-conformance found in the whole audit, all the greater.

The report summary was, as always, very positive: " The company is using the quality management tool as a management tool for improvement. There is evidence of commitment from the top management in the maintenance and use of the system. The company is constantly reviewing the system to reflect changes...great improvement identified... continuous ISO9001:2000 registration is therefore recommended.

2006 assessment
During 2006 we developed our financial systems and included them in our quality management system, which guarantees efficient and prompt payment of suppliers, and correct invoicing and storage of all financial records. Again during our annual inspection the auditor found no incidences of non-compliance with our systems, and the report summary said:

"An improved quality management system, well documented and maintained. Great evidence of commitment to the system by senior management and staff in general. Customer focused, with improved communication processes both internally and externally with all interested parties and customers.
The assessor has no concerns to raise - continuous ISO9001:2000 registration is therefore recommended."

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2005 assessment
As a new registrant we were again audited in September 2005 to check that the systems were being used and hadn't just been implemented for the inspection and then ignored.

The assessor found no procedural non-conformances, and made no observations of areas of concern. The report summary was as follows:

"Excellent management system in place and great improvements made since last visit. Evidence of management commitment to the system, assessor therefore has no concerns to raise continual registration to ISO 9001:2000 is recommended."

Initial independent assessment
On 4th February 2005, following several months of preparation, we were first independently assessed by an auditor from URS quality management systems for ISO 9001:2000 certification.

The auditor's report summary said:

"An exemplary well documented system with design and content to a high standard. Assessor has no concerns to raise, registration to ISO 9001:2000 recommended."

This means that we have a full set of clearly defined and independently certified policies and procedures in place to ensure that we remain focused on:

• Making sure our customers and users of our products and services are happy with them; and
• Continually improving our performance, products and services.

and that we meet:

• Our customer's requirements for quality policies; and
• All applicable regulatory requirements.

Scope of our registration
The scope of our ISO 9001:2000 certification was further extended in 2007 to include the distribution of medicines under our wholesale dealers licence, as well as all other areas of our work. Our ISO 9001:2000 registration covers:

"Development and supply of products, including medicines sold within the terms of the company’s Pharmaceutical Wholesale Dealers Licence, to minimise infection and harm to intravenous drug users.

Development and publishing of drug and health related information. Organisation and presentation of conferences and training courses."

Our system designer
We have been helped to develop our ISO 9001 compliant policies and procedures by Steve Hill Associates.

Steve is an independed consultant who comes in regularly to conduct audits, spot checks, as well as systematically reviewing our policies, procedures and documentation to ensure that everything remains up to date and accurate.