ISO 9001 Health Service Accreditation

Patients and Health Service Consumers are becoming more sophisticated, better informed and their expectations are growing. For any health service, the only way to keep up is to offer a commitment to patient outcomes and quality. In fact any organization, whatever their size or industry sector can give themselves a secure future by introducing a quality management system (QMS) such as ISO 9000 incorporating the Core Standards.

Benefits of implementing a quality management system include:

• policies and objectives set by 'top management'
• understanding consumer requirements with a view to achieving consumer satisfaction
• improved internal and external communications
• greater understanding of the organization's processes and risk control
• understanding how statutory and regulatory requirements impact on the organization and your customers
• clear responsibilities and authorities agreed for all staff
• improved use of time and resources
• reduced wastage
• greater consistency and traceability of products and services
• improved morale and motivation

What is a Quality Management System?

A quality management system in accordance with ISO 9001 will provide your organization with a set of processes that ensure a common sense approach to the management of your organization.

The system should ensure consistency and improvement of working practices, which in turn should provide products and services that meet customer's requirements. ISO 9000 is the most commonly used international standard that provides a framework for an effective quality management system.

What is ISO 9000?

ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be implemented.

ISO 9001, the requirement standard, includes the following main sections:

• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement Analysis and Improvement

What does it mean to me?

To gain the maximum benefit from ISO 9000 there are a number of steps to take:

1. Define why your organization is in business.
2. Determine the key processes that state 'what' you do.
3. Establish how these processes work within your business.
4. Determine who owns these processes.
5. Agree these processes throughout the organization.

For more information please complete our online enquiry form or contact us.

For Health Division training courses please email us or telephone 1300 730 134.

There are key steps that every company implementing a QMS will need to consider:

Purchase the Standard
Before you can begin preparing for your application, you will require a copy of the standard. You should read this and make yourself familiar with it.

Review support literature and software
There are a wide range of quality publications and software tools designed to help you understand, implement and become registered to a quality management system.

Assemble a team and agree your strategy
You should begin the entire implementation process by preparing your organizational strategy with top management. Responsibility for a QMS lies with Senior Management, therefore it is vital that Senior Management is involved from the beginning of the process.

Consider Training
Whether you are the Quality Manager seeking to implement a quality management system or a Senior Manager who would like to increase your general awareness of ISO 9001, there are a range of workshops, seminars and training courses available.

Review Consultancy Options
You can receive advice from independent consultants on how best to implement your quality management system. They will have the experience in implementing a QMS and can ensure you avoid costly mistakes.

Choose a registrar
The registrar is the 3rd party, like BSI, who come and assess the effectiveness of your quality management system, and issue a certificate if it meets the requirements of the standard. Choosing a registrar can be a complex issue as there are so many operating in the market. Factors to consider include industry experience, geographic coverage, price and service level offered. The key is to find the registrar who can best meet your requirements. A great place to start is by contacting us.

Develop a Quality manual
A Quality manual is a high level document that outlines your intention to operate in a quality manner. It outlines why you are in business, what your intentions are, how you are applying the standard and how your business operates.

Develop support documentation
This is typically a procedures manual that supports the Quality manual. Quite simply, it outlines what you do to complete a task. It describes who does what, in what order and to what standard.

Implement your Quality Management System
The key to implementation is communication and training. During the implementation phase everyone operates to the procedures and collects records that demonstrate you are doing what you say you are doing.

Consider a pre-assessment
A pre-assessment by your registrar normally takes place about 6 weeks into the implementation of the quality system. The purpose of the pre-assessment is to identify areas where you may not be operating to the standard. This allows you to correct any areas of concern you may have before the initial assessment.

Gain registration
You should arrange your initial assessment with your registrar. At this point the registrar will review your QMS and determine whether you should be recommended for registration.

Continual assessment
Once you have received registration and been awarded your certificate, you can begin to advertise your success and promote your business. To maintain your registration, all you need to do is continue to use your quality system. This will be periodically checked by your registrar to ensure that your Quality System continues to meet the requirements of the standard.

BSI Management Systems has a structured route to registering to ISO 9001. The BSI
route to registration is designed to make your experience easy and reassuring, with minimal disruption to your own core activity.

For more information please complete our online enquiry form or contact us.

For Health Division training courses please email us or telephone 1300 730 134.

We are experts in training as well as assessment and have a network of public and in-house courses tailored to the health industry and dedicated to teaching you the skills you need before, during and after registration to the standard

For more information please complete our online enquiry form or contact us.

For Health Division training courses please email us or telephone 1300 730 134.

Registration to ISO 9000 and the Core Standards takes place when an accredited 3rd party such as BSI Benchmark's Health Division visits an organization, assesses the management system and issues a certificate to show that the organization abides by the principles and requirements set out in ISO 9001 and the Core Standards.

Your Quality Management Systems' certificate is a sign of acceptability which saves you from having to prove your quality standards to discriminating customers. ISO 9000 speaks an international language.

Why do I need registration?

Gaining registration to ISO 9000 through BSI Benchmark will help your organization flourish. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO 9000 will help you demonstrate to customers that you have a commitment to quality.

The regular assessment process will help you to continually use, monitor and improve your management system and processes.

Registration can improve overall performance, remove uncertainty and widen market opportunities. In addition, ISO 9001 is designed to be compatible with other management systems standards and specifications such as OHSAS 18001 Health and Safety and ISO 14001 Environment. They can be integrated seamlessly via our Integrated Management. They share many principles so choosing an integrated management system can give excellent value for money.

For more information please complete our online enquiry form or contact us.

For Health Division training courses please email us or telephone 1300 730 134.