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Information paper prepared for the Review of the MBBS Program School of Medicine The University Of Queensland

September 2009




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Relevant standards

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Basic terms

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Why adopt a QMS?

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Management commitment and responsibility

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Key decisions required before starting a QMS

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Developing and implementing a QMS for certification

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Keeping it simple

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APPENDICES Appendix 1 Brief outline of a typical method of developing and implementing a QMS Appendix 2 Brief outline of a typical certification process

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1.0 INTRODUCTION1 A Quality Management System (QMS) is a set of policies, processes and procedures for the planning and operation of an organisation’s core business. A functioning QMS enables the organisation to identify, measure, control and enhance its business processes and ultimately improve its business performance. The ISO2 9001 approach to quality management offers a comprehensive framework on which to build processes that help ensure key business objectives are achieved. It has been estimated that over a million organisations ranging across all industry and business types in 161 countries have implemented ISO 9001-compliant business management systems. Certification of an ISO 9001based QMS is recognised internationally.

2.0 RELEVANT STANDARDS The ISO 9000 series of standards concern quality management. They address quality principles and processes surrounding the design, development and delivery of a general product or service. An organisation can participate in a continuing certification process to demonstrate its compliance with the ISO 9001 standard. Relevant standards include: AS/NZS ISO 9000:2006 Quality management systems – fundamentals and vocabulary This standard describes what a QMS is and defines related terms. It is a guidance document and not intended for certification purposes. AS/NZS ISO 9001:2008 Quality management systems – requirements This standard specifies requirements for a QMS where an organisation: • needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and • aims to enhance customer satisfaction through effective application of the QMS, including processes for continual improvement of the QMS and the assurance of conformity to customer and applicable regulatory requirements. The standard requires an organisation to manage and control all activities that impinge on its ability to provide quality services. It provides a generic framework of matters that need to be addressed to manage the organisation’s business, without prescribing how that management is to be conducted. This allows the flexibility for each organisation to develop
This paper is based on information obtained from AS/NZS ISO 9000, AS/NZS ISO 9001, ISO 9004, HB 90.7-2000 and 2 International Organisation for Standardisation. Because "International Organisation for Standardisation" would have different acronyms in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), its founders decided to give it a short, all-purpose name. They chose “ISO”, derived from the Greek isos, meaning “equal”. Whatever the country, whatever the language, the short form of the organisation's name is always ISO. ISO is the world’s largest developer of international standards. It is a network of the national standards institutes of 157 countries with a central secretariat in Geneva, Switzerland to coordinate the system. Its website is


a QMS suitable to its needs. The standard does not set competencies, performance indicators, etc., but it does require the organisation to identify applicable competencies, performance indicators, standards and norms and where and how they are to apply to the management of its business. The standard is not concerned with the particular business conducted by an organisation, it applies to how that business is managed. AS/NZS ISO 9004:2000 Quality management systems – guidelines for performance improvements This standard concerns continual improvement, measured through the satisfaction of customers and other interested parties. It is a guidance document and not intended for certification purposes. Documents have been developed which adapt ISO 9001’s generic management system to specific business sectors. Documents relevant to the School of Medicine are: • ISO/IWA 2:2007 Quality management systems – guidelines for the application of ISO 9001:2000 in education (released by ISO) • HB90.7-2000 Education and training Guide to ISO 9001:2000 (published by Standards Australia) HB 90.7-2000 Education and training Guide to ISO 9001:2000 This handbook provides guidance to education and training organisations for developing and implementing a QMS based on ISO 9001:2000.3 It lists each ISO 9001:2000 clause and then explains how it may be implemented using terminology and examples from education and training environments.

3.0 BASIC TERMS ISO 9001 refers, inter alia, to customers and products. With respect to the education field, “customer” could include: • a student • a company or organisation with which a research contract, consultancy agreement or other contract is entered into • an industry • an internal customer (ie within the University) • a government, regulatory body, accreditation body, etc. • a relevant society group, staff members, society as a whole. ISO 9000:20064 defines “product” as “the result of a process” and a “process” as a “set of interrelated or interacting activities which transforms inputs into outputs.” For an education provider, “product” could include: • enhancement of skills/knowledge/understanding/attitude/values • provision of - an educational environment - a curriculum and other resources - a community service - research outputs for the enhancement of skills/knowledge/understanding/attitude/values.
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The handbook is also applicable to ISO 9001:2008

AS/NZS ISO 9000:2006 Quality management systems – fundamentals and vocabulary


Some examples of products and customers of education and training organisations include: Education and training Product Customer organisation Universities, TAFE colleges learning environment; students; employers; industry; enhancement of knowledge, professions; communities; skills, attitudes, values governments Universities, TAFE colleges fundamental and applied academic, professional, research industrial communities; society Public school learning environment; pupils; parents; local enhancement of knowledge, communities; government skills, attitudes, values

4.0 WHY ADOPT A QMS? Formal recognition of an ISO 9001-based system may benefit the School of Medicine by contributing to its goal of being Australia’s leading medical school. Examples of specific items which the School of Medicine’s QMS could cover may include MBBS program policies, procedures, guidelines and statements; all aspects of student administration; curriculum and related documentation; organisational structures, relationships, responsibilities and accountabilities; delivery of teaching, learning and assessment practices; teaching staff arrangements; communication practices, etc Besides providing assurance to customers, a QMS can also be used to: • improve the performance, coordination and productivity of the organisation • identify objectives and focus on customer expectations • provide evidence of the organisation’s capability to customers and potential customers • achieve and maintain the desired quality of products and services, thus continually meeting the customer’s needs • establish a baseline for continual improvement.

5.0 MANAGEMENT COMMITMENT AND RESPONSIBILITY Section 5 of ISO 9001 relates to management responsibility. Section 5.1 states: 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: (a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements (b) establishing the quality policy (c) ensuring that quality objectives are established (d) conducting management reviews, and (e) ensuring availability of resources. Other subsections refer to senior management’s responsibilities with respect to customer focus, (section 5.2) quality policy (section 5.3), planning (section 5.4), responsibility, authority and communication (section 5.5) and management review (section 5.6).


6.0 KEY DECISIONS REQUIRED BEFORE STARTING A QMS Other than the fundamental decisions of whether management is willing to develop and implement a QMS and/or commit to the ISO 9001 path, two basic decisions that need to be made before planning a QMS are: • what is to be covered by the QMS? • to which part of the organisation is the QMS to apply? A QMS can apply to any part of an organisation, such as: • management • administration • faculties, schools, units • maintenance and support functions. The organisation may decide to include any or all of its operations in the QMS. It may elect to have a separate QMS for each sector or an overall QMS covering the whole organisation. If an organisation receives an ISO 9001 compliance certificate, it will also be given a scope of certification which lists matters for which the organisation is certified. 7.0 DEVELOPING AND IMPLEMENTING A QMS FOR CERTIFICATION5 Developing and implementing a QMS consists of several steps including: • determining the needs and expectations of customers and other interested parties • establishing a quality policy and quality objectives of the organisation • determining the processes and responsibilities necessary to attain the quality objectives • determining and providing the resources necessary to attain the quality objectives • establishing methods to measure the effectiveness and efficiency of each process • applying these measures to determine the effectiveness and efficiency of each process • determining the means of preventing nonconformities and eliminating their causes • establishing and applying a process for continual improvement of the QMS. A quality manual needs to be developed and maintained. It must include: • the scope of the QMS • the documented procedures established for the QMS, or reference to them • a description of the interaction between the processes of the QMS. The quality manual must address each clause of ISO 9001.

8.0 KEEPING IT SIMPLE Basically, the QMS is the way an organisation operates. Maximum use should be made of existing structures, procedures, forms and other tools of management and administration. New documentation, procedures, etc. should only be introduced if they are absolutely necessary for addressing requirements of ISO 9001.

Refer appendices 1 and 2 for further information on developing and implementing a QMS, and a typical certification process




There are many ways that an organisation may develop and implement a QMS. There is no particular merit in any one method over another. The main, perhaps the sole, criterion is that the method works for the organisation concerned. The following sets out one approach of implementing a QMS within an education and training organisation. It is a generic plan which can be adapted by an organisation to suit its particular needs. It is an example only. PHASE 1 – Demonstrate executive commitment to quality Establish: • a vision for the future • an annual budget for the process. The organisation’s director needs to provide leadership. PHASE 2 - Form steering committee to plan implementation It is preferable to have the organisation’s director chair the steering committee. The committee should: • be representative of all areas of the organisation, particularly those areas that are within the scope of any desired certification • have the authority to approve the organisation’s quality policy, review implementation and evaluate the system’s effectiveness • participate in awareness training and team management • participate in skills development (auditing, procedure writing). PHASE 3 - Appoint a quality coordinator The quality coordinator should: • report to the director and to the steering committee • have a good understanding of quality concepts and skills, as well as a broad knowledge of the organisation’s operations • have good interpersonal skills and be able to promote quality within the organisation, and • coordinate the certification process, ensure that procedures, instructions and similar documentation is prepared, assist in training, such as auditing, procedure writing and similar quality associated training needs. The role of quality coordinator needs to have the visible support of the director and the steering committee. PHASE 4 - Establish reasons for implementation and scope The steering committee should establish:

Source: HB90.7-2000 Education and training Guide to ISO 9001:2000


• • • •

the reasons for implementation of a QMS the scope of the QMS that best suits the need of the organisation if certification is to be sought the target dates for the implementation stages, including certification.

PHASE 5 - Create quality awareness within the organisation The steering committee should: • develop, announce and explain the quality policy to all staff • arrange awareness courses for all staff • ensure the roles of the steering committee and quality coordinator are understood by all staff. PHASE 6 - Determine key functions to be controlled by procedures Matters to be identified include: • the critical activities that require procedural control • the existing systems within the organisation and the degree of match to the requirements of the selected standard (ISO 9001). PHASE 7 - Develop a quality manual The steering committee/quality coordinator should develop the quality manual (which should be brief, and easy to read and understand) as: • an explanation document for staff and customers, and • a means of integrating existing systems with the requirements of the standard and implementing additional systems to cover any shortfall. PHASE 8 - Establish staff participation The steering committee should arrange suitable training sessions to: • explain the aims and benefits of the QMS • explain the purpose of the quality manual • explain the implementation plan • train staff in writing procedures. PHASE 9 - Prepare procedures The steering committee/quality coordinator need to ensure that the following are developed and put in place: • a procedure on writing procedures • a numbering/identification system • a system for reviewing procedures • a time related implementation plan. PHASE 10 – Implement QMS The steering committee/quality coordinator should proceed with implementation according to the timetable developed in Phase 4. This may be a slow or long-term process, particularly if there is need for a culture change. PHASE 11 - Audit and review QMS The quality coordinator should establish an audit schedule and arrange for suitable staff to be trained as internal quality auditors.


The steering committee should hold regular reviews during all phases of implementation to answer such questions as: • Is the QMS still appropriate? • How many nonconformances with QMS requirements are occurring? • How many customer complaints have been received and what are the basis of these? • What are the results of internal quality audits showing?



There are two classes of certification: • second party certification where the party carrying out the certification audit is the customer. Such certification may or may not be recognised by other organisations • third party certification where the party carrying out the certification audit is independent of both the organisation and its customers.7 This certification is recognised by other organisations.8 At an early stage, discussions are usually held with certifying bodies to find out what each body offers, the likely cost9, over what period the certification will be effective, the frequency of intermediate audits and their cost, etc. Some bodies offer an initial consultation or pre-assessment at little or not cost. The certification process generally involves: • the organisation makes formal application to the certification body. The application will normally include a description of operations carried out by the organisation, the product range and any other information the certification body may request • the certification body may request a questionnaire be completed • the organisation’s quality manual is assessed in relation to the standard against which certification is sought, ie how well does the organisation’s description of its activities contained in its quality manual match the requirements of the standard • the certification body may conduct a pre-assessment check or go straight to the certification audit. During the audit, the assessor will use the quality manual and any system procedures as a guide to how the provider operates. The assessor’s operative words will be “show me.” The assessor will look at records and documents to check that the organisation is actually following its quality manual. Where differences are found, the assessor’s actions depend on how serious the nonconformances are deemed to be • once certification is granted, the certification body will conduct compliance audits of the QMS over the period for which the certification is valid. Each of these audits is not as comprehensive as the initial certification audit, but all aspect s of the QMS will be audited during the certification period.

Some examples of certification bodies are NCS International, SAI Global, Benchmark Certification. ISO offers advice on how to choose a certification body at tm 8 In Australia, third party certification bodies are subject to audit and accreditation by JAS-ANZ (Joint Accreditation System – Australia and New Zealand) 9 Cost will be dependent on the size, contents and complexity of the QMS



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