A Quality Management System provides a way for Management to give direction to staff without removing the sense of ownership and initiative that is now vital to the success of all organisations.

It is no longer practical for managers to watch over the activities of staff or to appoint supervisors to monitor if and when people are performing. In Australia today we have a workforce that is motivated to produce high quality work.

Providing Management does not have systems in place that make it difficult to produce quality results, the staff of the organisation will endeavour to delight both the customer and the manager.

It is a sad fact however, that most Management Systems do more to interfere with the worker, either by not providing the direction or resources necessary to do the job or by imposing blockages that impede the work being done.

A well-developed Quality Management System will identify the resources that are necessary to get the job done and also identify any blockages. It is then up to managers to do their job by ensuring the resources are provided and removing the blockages.

The resources we refer to include training, equipment, time and methods. The blockages are the need for unnecessary approvals and inefficient operating methods.

The Quality Management System should ensure the resources are identified and supplied and as it matures will lead to greater efficiency and effectiveness.

There has been a lot written about Quality Management Systems over the last few years. Many of these reports have identified the cost and inability to guarantee quality, as major problems.

In the early days of the certification of Quality Management Systems there was a tendency to over document the procedures. This had a number of consequences, which included:

• Increasing the cost of the system
• Making the overall system inflexible
• Producing documents that were seldom referred to
• Focusing on the documentation rather than the work.

More recent thinking on the Quality Management Systems is that the focus should be on developing a Management System that complements the way the business needs and wants to operate. The standard, AS/ISO 9001, should be used as a model or checklist of the issues that need to be considered in the structuring of the Management System, rather than the blueprint upon which the Management System must follow and include every element. In many cases an element of the model may be inappropriate for the business or more readily covered in another procedure.

Some businesses have tried to jump through hoops trying to find somewhere in their business that they have procedures for things like "Customer Supplied Product" or "Servicing". Even the question of whether a business has "Design" as one of the procedures is often debated over for inordinate amounts of time. It is up to the business to decide if it needs to include any particular element separately in their procedures.

In the Nursing Home environment, a properly designed and implemented Quality Management System can improve effectiveness and efficiency. The investment in Quality is not free, but it can pay back the organisation many times.

In this article, we have recommended a path that a Nursing Home could follow to bring their Management Systems in line with the standard model and then have it certified by one of the approved certification companies.

There is an urgency in moving the Nursing Homes in this direction because the Australian Commonwealth Department of Health and Family Services has issued guidelines for the accreditation of Nursing Homes. Unless these guidelines are met, the Nursing Homes will have Commonwealth subsidies reduced or removed.

The question arises however," Why should a Nursing Home spend the time and money on installing a certified Quality Management System?"

The Australian Standard for Quality Management Systems is AS 9001. This standard is the same as the international standard that has been adopted by over seventy other countries since it was first published in 1987. The most recent version was issued in 1994.

A Quality Management System aims to assure the customer, in the case of Nursing Homes the Resident, of the consistent and improving product or service. It does this by requiring all processes that have an impact on the Resident to be carefully planned and approved. The usual method for doing this is to have the process fully documented.

The documents prepared for the Quality Management System are used in a number of ways including:

• Control
• Training
• Review
• Evidence.

The documents are distributed or are made available to all staff involved in the process. When required the staff should refer to the documents as a guide to how the work is done. The document does not have to be a lengthy description of each step with all the possible variances. Often the document may be in the form of a checklist or flow chart that can be referred to as each step of the process is completed. Thus the Quality Management System is used to control the way the work is done.

When a staff member is first assigned to a process, the documents should be referred to as part of his/her training. No person should be assigned work before they have been trained and found to be competent to do the work.

The documented procedures and the records that are produced during the process, provide evidence that the processes have been planned and are approved at an appropriate level and that the procedure has been followed.

Despite the frequent reference to "documents", efforts in designing a good Quality Management System should be focussed on keeping the amount of documentation and bureaucracy to a minimum.

Processes only need to be documented if they impact on the Resident or the service provided and the person who performs the process has not been appropriately trained. That is, a document should only be prepared if the lack of the documented procedure would have a detrimental effect on quality.

For example a Dietician does not need a specially prepared procedure to prepare the menu for the Residents. There is an expectation that because of their training, Dieticians are able to do the work.

Likewise the cutting of the grass or gardening would not require a documented procedure, as it would not impact on the Resident or the service.

The model for Quality Management Systems requires the processes to be planned, tested, reviewed and followed. The terms often used by quality professionals are the Plan, Do, Check, Act (PDCA) cycle for continuous improvement.

The PDCA cycle is intended to be a model for continuous improvement. This means that once the process has been implemented it is reviewed again and planning is started to make it better.

As part of the continuous improvement cycle, the documents of the Quality Management System form the basis for the next step along the improvement continuum. The first step of any planned change should be to refer to the current standardised processes and review that they are meeting the objective of the business and meeting the Residents requirements.

If we imagine that quality could be measured and graphed, in a situation of constant quality, the graph would look something like the following in Figure 1.

If we had a situation of continuous improvement the graph would have a slope on it as shown in Figure 2.

The PDCA cycle is used with the intent of continuous improvement. However it can be observed from life situations that if a team of people identify a better way of doing the job, they will begin doing it the better way. After some time the originators of the ideas move onto some other area or lose the commitment to the improvement. The quality of the work begins to decay back to the original state.

Sometime later another team will try to improve the job again, and the cycle will be repeated. The graph of quality vs time thus takes on a saw-tooth appearance as shown in Figure 3. Thus a considerable amount of time and effort is spent on redoing the previous improvements.

A well-designed Quality Management System acts as a wedge on the PDCA cycle and stops the decay, as shown in Figure 4. By standardising the improvements, the next improvement cycle starts at the high quality level reached by the previous cycle, rather than the minimum level they would have had to start at if the improvement had been allowed to decay.

The Commonwealth Department of Health and Family Services has issued guidelines on the accreditation requirements of Nursing Homes.

The accreditation standards for Residential Aged Care facilities will be used to assess the overall quality of services provided by Nursing Homes and Hostels. The standards have been developed in partnership with aged care stakeholders and they build upon the strengths of the present Outcome Standards.

The new system has four accreditation standards:

• Management Systems, staffing and organisational development
• Health and personal care
• Resident lifestyle
• Physical environment and safety systems.

A certified Quality Management System will help meet the first of these four requirements.

To rate well against the Accreditation Standards, facilities must have Quality Management Systems in place that work, not only to meet the expected outcomes for all standards where applicable, but also to improve performance against them. This involves a cycle of self-assessment, planning, implementation, and evaluation. A PDCA cycle. Through this process, Nursing Homes will be expected to improve their systems and to address problems and deficiencies, as they arise.

To meet the Quality Accreditation Standards, Nursing Homes will need to show:

• A staffing mix which meets the care need of their Residents
• The recruitment of appropriately skilled staff
• The continued development of staff skills
• The provision of adequate opportunities, supervision and appropriate on-the-job training.

There is a requirement that Nursing Homes continue to have an appropriate mix of skills and experience. The standards for accreditation require that services employ appropriately qualified and skilled staff to meet the needs of the Resident.

There will be a focus on complaint handling procedures in the accreditation requirements. It is necessary to be able to resolve the complaint for the complainant. This will be achieved through both a complaint handling system within each facility and a new external complaints scheme.

Each nursing facility will need to establish a comprehensive, complaint handling system. This system will be assessed as part of the accreditation process to make sure that everyone understands it in the facility, uses it, and it works to resolve complaints effectively.

The focus of the complaint handling procedure will be to resolve each complaint for the complainant in a timely manner.

As part of the accreditation requirements, each of the four standards will be independently audited.

There are a number of companies in Australia that are registered for the audit and certification of Quality Management Systems. Shortly the Department of Health and Family Services will nominate one or more of these companies to certify Nursing Homes to the requirements of the new legislation.

A Quality System will give the Nursing Home a structured basis to improve its service to Residents. It will encourage a standardisation of the way work is done and as the improvement cycle continues the best way to perform each process will be identified and become the standard way of doing work.

The system will provide an accessible source of instruction for training staff in the way work should be done, and as part of the recording system ensure that staff receive recognition for tasks mastered.

The complaints handling procedure will ensure a systematic way of improving the quality of the service provided by the Nursing Home and increase the Residents' satisfaction and lifestyle.

The AS/ISO 9000 series, available from Standards Australia, includes a variety of standards and guidelines. The main standards are AS/ISO 9001, 9002 and 9003. The remaining publications are general guidelines on how to select one of the main standards for your organisation, and then use them to implement an effective Quality Management System. There are also some a few guidelines for specific industries. There is not a guideline for Nursing Homes however AS 3904.2 explains how the standards can be implemented in a service environment.

The main guideline for Quality Systems is AS/ISO 9004.1: 1994 "Quality Management and Quality System elements. Part 1: Guidelines". This standard explains in general, and not industry specific, what a Quality Management System is and how it should be used. This standard is not appropriate for audit purposes but should be referred to, to give the user an understanding of the philosophy of Quality Management and how it should be applied in a systematic way.

The standards AS/ISO 9001, 9002 and 9003 are used for certification purposes. These standards lay out very specific requirements for a Quality System. They were originally written for the manufacturing industry, however they were redrafted in 1994 and are now applied across a wide mix of organisations.

AS/ISO 9001 is a model for quality assurance in design, development, production, installation and servicing. AS/ISO 9002 has all the same requirements as AS/ISO 9001 except for design. AS/ISO 9003 is intended for warehousing and retailing type organisations and has a number of elements that are in the other two standards removed. The appropriate standard for the Nursing Home environment is AS/ISO 9002. There is a comparison of the three standards in the appendix.

There are 19 elements of the AS/ISO 9002 standard and in order to meet the requirements the Nursing Home must consider how each element applies to its standard procedures and document how those procedures are performed. It is usual for the organisation to prepare a series of procedures that detail the way activities are performed. These procedures form the Quality Manual.

There is a requirement by the standard that the organisation have both a Quality Policy and Quality Manual. AS/ISO 10013: 1996 is a guideline prepared by Standards Australia that suggests how to structure a Quality Manual. These are suggestions, and there is nothing in AS/ISO 9002 that mandates the use of this document.

It is necessary that the Management of the Nursing Home has a Quality Policy and ensures that staff is aware of its requirements. This policy must include objectives. Some of these objectives will focus on improvement and elsewhere in the Quality Management System there should be detail of where the organisation is with meeting those objectives and what is being done to improve on them.

How the staff is organised must be documented and staff must be aware of their authorities and responsibilities. Some of the staff will need the authority to fix problems that occur, and the rest of the staff should be aware of who they can approach to have problems solved. The Nursing Home should have a method for verifying that the problem has been fixed and will not recur.

As part of the overall objective of continuous improvement, problems need to be identified and when a solution found, implemented. A record of the event should be made.

Adequate resources must be provided to meet the documented requirements of the standards and all legal and contractual requirements.

An important resource that needs to be identified is a Management Representative. This person is responsible for the establishment and maintenance of the Quality System. The Management Representative must be part of the Nursing Homes Management Team and must have the necessary authority to allocate resources to the maintenance of the system.

For the Quality System to continuously reflect the needs of the Nursing Home and the people cared for by the home, Management should regularly review the system and how it is working. The Management Representative provides reports to the Nursing Homes Management on the performance of the Quality System, and this report should form the basis for improvement of the system.

As previously indicated, the structure of the Quality Management System needs to be documented. This is usually done in general terms in the Quality Manual and covers how the requirements of the standard will be met.

If a three-layered model is used for the design of the overall system, the Quality Manual should be developed and approved by senior Management. This is the document that instructs the rest of the organisation on "What" is to be done. In the two-layered model the Quality Manual will have considerably more detail and explain "How" the work is done.

The Quality System Procedures should be integrated with the way work is done in the Nursing Home so that the Quality Management System is effectively implemented. The range and detail of the procedures will be dependent upon the complexity of the work, the methods used and the skills and training needed by personnel involved in carrying out the work.

These procedures may refer to other documents that define in greater detail how the work is performed. These subsidiary documents are usually work instructions, checklists, flowcharts or forms and may be either produced especially for the Nursing Home or may be part of industry standard guidelines or instructions.

There is a requirement in the standard for the Nursing Home to document how it will plan its activities to meet the quality requirements. The standard details, specific facets of the quality planning process that need to be included in the design of the Quality Management System. The things the Nursing Home needs to consider include:

• Preparation of Quality Plans
• Controls, including staff resources and skills
• Compatibility with all activities
• Updating of control and work techniques
• Measurements that need to be taken
• Verification at appropriate times and recording of the verification
• Clarification to staff of any standards
• Any records that may be required.

The relationship between the Nursing Home and the Resident needs to be clearly defined so that both the Nursing Home and the Resident understands what is being offered and accepted.

The Department of Health and Family Services requires a Charter of Residents Rights and Responsibilities to be prepared by the Nursing Home. The minimum requirements of this charter have not been detailed by the department at this time, however it is a requirement of the standard that the Nursing Home have a documented procedure for reviewing all its contracts with the Residents.

These procedures should include time for the Nursing Home to identify all the needs of the Resident and ensure that it has sufficient resources to meet those needs.

It is appropriate that the Charter of Residents Rights and Responsibilities include details on the complaint handling procedure and any other channels of communication available to the Resident or the Nursing Home.

The Nursing Home will need to keep a record of all information given by the Resident and that the entire Contract Review process has been completed as detailed.

Although Design Control is an element of the standards it is unlikely that it will be required in the Nursing Home environment. Design Control is in AS/ISO 9001 but is not required by AS/ISO 9002.

All documents that impact on the care of Residents need to be controlled. Management needs to assign responsibility to prepare and approve each document and to have a system that ensures all appropriate documents are under distribution control and are updated when appropriate.

Within the Quality Management System documents may be in any appropriate media, including hard copy or electronic media.

Documents that impact on the care of the Resident or the quality of any service offered by the Nursing Home need to be included in the Quality Management System, however care should be taken to minimise the number of documents. There is often a tendency to include too many documents in the Document Control system and to over specify the control mechanism.

The simplest form of Document Control is to have only one copy of a document and that document is verified and approved by one person. An index of all documents in the Quality Management System needs to be prepared and this index needs to detail current revision status.

The Document Control system should assure that the staff does not use obsolete documents.

Often documents that contain data used for work activities need to be retained after the work is completed for legal or knowledge preservation purposes. The Document Control procedure should include provision for this eventuality.

All controlled documents need to be reviewed on a regular basis, however the Nursing Home Management should determine the frequency. Some documents require review much more frequently than others do.

Staff needs to have access to documents that affect their work.

A procedure needs to be documented and followed, that ensures all purchases that impact Residents needs come from approved suppliers and meet approved specifications.

The procedure should include how a supplier is chosen and how orders are placed with the supplier. An Approved Suppliers List should be prepared and this list should detail what product may be purchased from each supplier and if any inspection is needed on the product when it is delivered. Only products that impact on the well being of the Resident or the quality of service offered by the Nursing Home need to be included in the procedure.

Care should be taken to ensure that incidental purchases that have little impact on the Resident are not included in the Quality Management System, to prevent making the system too complex and difficult to use.

The purchase of any product that is included in the Quality Management System should be done by purchase order. The purchase order should include the name of the supplier, the product being ordered in sufficient detail to prevent confusion and reference to any standards or specifications that need to be referred to. A staff member with the appropriate authority should approve the purchase order.

When the product is delivered it should be inspected to ensure it meets the specifications on the purchase order.

In the standard, this section is titled "Control of Customer Supplied Product", however these terms often lead to misunderstanding. Residents supply a Nursing Home with a wide variety of articles and materials that remain the property of the Resident. These articles and materials are "Customer Supplied Product" for the purposes of the standard but for clarity they may be referred to as "Resident Supplied Material" in a Nursing Home environment.

The Nursing Home must have a control system in place to guarantee that these things are clearly identified, used when appropriate and cared for so that they are not damaged.

Part of the process should include inspection of the material to ensure that it meets specification and a record should be made of any inadequacies. These may include damage to the material or past expiry dates.

Storage facilities should be provided for Resident Supplied Material.

The product of a Nursing Home is "Care". Product Identification and Traceability may not be required in a Nursing Home, however Management should consider the requirement for labels and maintaining records of material that is purchased or supplied to the Nursing Home. The identification and traceability of this material may be covered in other procedures.

There are many processes and care activities performed in a Nursing Home. Management needs to identify and document processes that are best controlled via documentation. Procedures need to be documented where the absence of such documentation of the procedures could adversely affect quality.

The form of the documentation and the degree of detail should be decided by Management.

Where it is decided documentation is required, information pertaining to the type of equipment that should be used, and in what environment the activity is conducted should be included. The documentation should include reference to appropriate standards and what types of monitoring are necessary.

A manager with the appropriate level of authority must approve the documentation. However it is up to Management when designing the Quality Management System to decide what is the appropriate level of authority to approve this documentation.

Any maintenance, of equipment used by the Nursing Home, may need to be documented under this procedure. Often a maintenance schedule and reference to operator manuals supplied by the manufacturer is all that is necessary.

Most activities in the Nursing Home are difficult to verify after the activity is completed, therefore only appropriately trained or qualified staff should perform such activities.

Records should be kept of all activities carried out by the Nursing Home, but this is especially true of activities that affect the Residents health or lifestyle and are difficult to verify after the fact.

It is this element of the Quality Management System that causes the most problems and greatest cost. Management often implements a system that has too many documents and too much detail.

Appropriate training can often reduce the amount of documentation required.

In most cases the Inspection and Testing element is not required in a Nursing Home. Inspection and Testing procedures can be included in the documentation for Process Control or Purchasing.

If the Management of the Nursing Home decides that there should be a separate procedure for Inspection and Testing, consideration should be given to the Inspection and Testing of material that is purchased.

Testing does not have to involve detailed scientific methods, if they are not appropriate. It may simply involve an inspection and comparison with some type of standard. The inspection could be recorded on the delivery docket and kept.

Some of the service offered by the Nursing Home does include material product eg meals. If there is no reference to final inspection in the Process Control procedure then it may be necessary to include a separate document under this procedure.

The calibration requirements of equipment used by the Nursing Home for measuring Resident wellbeing needs to be determined and maintained. A documented procedure is required.

Much of the equipment that is affected by this procedure will be used to monitor the Residents health. This equipment needs to be checked when purchased to ensure it gives accurate data and then checked at regular intervals. Usually the manufacturer will supply instruction on how to calibrate the equipment and how often this should be done.

A record of the calibration should be kept for the life of the equipment and for as long as any reading from the equipment is relevant to the Resident or the Nursing Home.

If appropriate, the equipment should carry a label advising of the status of the calibration and when the next calibration is scheduled.

Only staff qualified to perform such work should perform calibration, or it should be sub-contracted out to an organisation that is qualified to do so.

In most cases the Inspection and Test Status element of the standard is not required in a Nursing Home. If deemed appropriate there may be a small procedure developed to identify the calibration status of the equipment being used.

Another activity that may require some status indicator is the preparation of meals.

Non-conforming product in a Nursing Home is generally restricted to purchased material or material supplied by Residents. When non-conforming material is identified, it should be clearly marked as non-conforming and action taken to prevent it being used until the problem is rectified.

Management needs to delegate the responsibility and authority to a staff member to fix the problem. Appropriate ways of fixing the problem is to have the material reworked, accepted by some type of concession, classified as something else or rejected and scrapped.

A procedure may not be required if covered under other elements of the standard.

The Corrective and Preventative Action element of the standard requires a documented procedure that describes how problems (or potential problems) are identified and action taken to fix or prevent them.

Corrective action relates to problems that have been identified and Preventative action relates to a process of identifying potential problems and fixing them before they occur.

The Corrective Action process is usually activated by a customer complaint, investigation of a cause of non-conforming product and audits.

The Preventative Action process is usually activated by Management or staff review of an activity or situation and identifying a possible cause for problems.

The steps to handling Corrective and Preventative Action are:

• Identify the problem
• Determine step to deal with the problem
• Identify someone to take the necessary action and having them do so
• Reviewing the situation to ensure the problem has been fixed.

Records need to be kept of the activities involved in Corrective and Preventative Action.

Under this element a Complaint Handling Procedure should be developed. The Commonwealth Department of Health and Family Services has identified a special interest in requiring a detailed and functioning Complaint Resolution Procedure.

Services offered by a Nursing Home do not require documentation for this procedure. In a Nursing Home the requirements of this element can be usually handled under other procedures such as Resident Supplied Material and Process Control.

Any records that impact on Resident wellbeing and a number of records specially noted in the standard need to be identified, designed and controlled. Management needs to make a decision on what records are retained, how long they are retained and identify and provide resources to ensure they are not damaged. A documented procedure is required for this element.

The Nursing Home needs to establish a procedure to identify all the records that are kept. It is usual to have a Master Records List of all these records that includes information describing the record, how it is collected and by whom, where it is kept and how long the record is maintained.

The Master Records List should index the records and the records themselves should be indexed in such a way that finding a particular record at any time is facilitated.

All records should be legible and stored safely so that they are not damaged. Records may be stored as hard copy or in computer storage.

Where agreed by contract, the records should be made available to the Resident or the Resident's representative.

The entire Management System needs to be assessed by suitably qualified staff on a regular basis. The results of the assessments feed back into a number of other procedures to correct any problems and identify areas for improvement.

The standard refers to "Internal Assessment" as Internal Quality Audits.

It is necessary that the procedure establish a method for planning and implementing the internal assessments. Assessments should verify that all the requirements of the standard and the procedures developed for the Quality Management System are followed. The assessments should also determine the effectiveness of the Quality Management System.

The scheduling of the assessments needs to be decided by Management but consideration should be given to the status of the activity and how important it is to the wellbeing of the Resident and the Nursing Home.

The results of these internal assessments need to be recorded and any deficiencies found should be brought to the attention of the staff involved. It is usual for the results of the assessment to feed back into the Corrective Action procedure so that the problems are fixed.

A follow up assessment should verify that the problem has been fixed and that the Corrective Action works.

The results of the Internal Assessment form an important part of the input to Management Review activities.

People not directly involved in doing the work being audited should do the assessments.

It is necessary for Management to review the training needs of all staff, ensure training is scheduled and that records of training are maintained.

Personnel performing specific assigned tasks should be qualified on the basis of appropriate education, training and experience. A record of all members of staff should be maintained detailing all training and education.

On a regular basis, Management should review the qualification requirements of all activities that take place in the Nursing Home and ensure that sufficient trained staff is available to do the work. A schedule should be maintained of when each member of staff will receive any appropriate training.

The Commonwealth Department of Health and Family Services has identified Training as being of particular importance in Nursing Homes.

Servicing is an element of the standard that usually is not required in a Nursing Home Management System.

There are situations where Statistical Techniques do have special significance in a Nursing Home.

Nursing Homes are involved in monitoring the wellbeing of Residents. As part of this monitoring the Nursing Home Staff makes measurements of various aspects of health and uses these measurements to identify when a change in the status occurs. All staff involved in making these measurements should understand the significance of the measurements and how random and systematic variation may affect the results.

All measurements should be recorded and included in the relevant assessments.

Care should be taken to restrict the use of Statistical Techniques to appropriate areas.

The Quality Management System is documentation of the organisation and how work gets done. The Australian Standard AS 9000 series sets out a number of requirements that have been detailed earlier in this paper. However how the Quality Management System is structured should be based on what is suited by the organisation.

Often the Quality Management System is structured in three layers. The above diagram shows layers as being 1) The Quality Manual 2) The System Procedures and 3) Subsidiary documentation such as work instructions, checklists and forms. In smaller organisations the first two layers are often combined to give a two-layer structure.

It will depend on the size and organisation structure of the Nursing Home, which model is used.

Larger companies often use their Quality Manual as a marketing tool and prefer to make this document rather brief, and without too much detail on how the work is done, but rather what the intent of the organisation is with respect to Quality. Smaller companies prefer to have only one concise and unabridged document that can be referred to as required. Most stand-alone Nursing Homes will opt for the two-layer model but most larger groups of will use the three-layer model.

The first step on the journey to implementing the Quality Management System is the Quality Manual.

The Quality Manual is a requirement of AS/ISO 9002 and should incorporate the Quality Policy of the Nursing Home. As previously indicated the Quality Manual may be either a high level document with little detail on how the work is done, or it may include considerable detail and combined with System Procedures.

In either case the Quality Manual provides the guidelines for further development of the overall system.

If the System Procedures are not included in the Quality Manual, then they also need to be prepared at this stage.

It is usually the responsibility of Senior Management to oversee the development of the Quality Manual and System Procedures.

Once the Quality Manual and System Procedures have been prepared all the other procedures, which explain the work that needs to be done, need to be prepared.

The first step is to identify any documentation that already exists and bring it into the Quality Management System. There is no need to specially prepare documents for the Quality Management System. Operating manuals, forms, specifications and reference books may all be brought into the system without change. They should be reviewed to ensure they are current.

The documentation of the procedures may be achieved in various ways. The procedure may be detailed in a work instruction, a flow chart, checklist or even a form with an explanation of how it should be completed. The best Quality Management Systems use a variety of methods of documenting their procedures.

The staff involved in the work usually does the documentation of procedures. Once the documents are prepared, all staff involved in the process should have access to them.

The procedures need to be approved at an appropriate level of Management.

Staff will require training in the methodology of the Quality Management System. They should be made aware of the Quality Policy and any procedures that affect the work they perform.

It is usual for all staff to have some training in the Quality Management System and to be involved in the preparation of the documentation.

All staff should be aware of the Quality Policy and in general what is required by this policy.

This will be the most labour intensive phase as staff takes time to become familiar with the new requirements. There will also be some resistance to change from all levels within the organisation.

There will also be an opportunity to review the system and identify improvements. If the Quality Management System has been designed well, these improvements will feed back into the system and begin the first of the PDCA cycles.

One of the requirements of the standard is the Internal Audit. The requirements of this element were dealt with earlier.

Management and staff will find that the announcement of an audit will focus their minds on using the system. The initial audits should be carried out by an experienced Quality Management System auditor to ensure the overall system meets the requirements of the standard and that the documented procedures are being followed.

The outcome of the audit will be a number of non-conformances. Management should not despair at this stage. Everyone is learning and to have someone with a fresh view assess the system and identify opportunities for improvement should be welcomed.

The non-conformances should be documented as Corrective Actions and fed back into the overall system. In particular the Corrective and Preventative Action procedure.

It is usual for an organisation to have two or three internal audits before proceeding to the external audit.

The internal audits may be performed by Nursing Home staff who have had Quality Management System auditor training or by a consultant. It is sometimes best to have a mixed audit team with one or two Nursing Home staff and an experienced external auditor perform the first few audits. The medium to long term strategy should be to only use internal auditors.

The Department of Health and Family Services will identify a number of Certification Companies that may perform the independent audit. At the option of the Nursing Home, the Department may do the certification audit. The Certification Company should have been contacted sometime during the implementation phase to set a time for the certification audit.

One of the first requirements of the external audit will be to perform a desktop review. In this review the auditor will request copies of the Quality Manual and System Procedures. They will review these documents for compliance with the standard.

Once the desktop review has been completed, a time will be arranged for the independent audit. During this audit the auditors will review the remaining documentation and the work performed. Depending on the size of the Nursing Home this audit may require two to four man-days.

The outcome of the independent audit will be an identification of any non-compliance with the standard and the Nursing Homes own procedures. Providing there are no Major Non-conformances the Nursing Home will be recommended for certification.

There may be a number of minor non-conformances identified. The auditor will indicate what is wrong and reach agreement with the Nursing Home Management on a timeframe for correcting the problems. A second audit may be required. These non-conformances should be fed into the Correction and Preventative Action Procedure.

Management should treat any non-conformances identified by the auditors as an opportunity for improvement.

The Nursing Home will also need to meet the standards for Health and personal care of the Residents, Resident Lifestyle and Physical Environment and Safety standards to be accredited.

However a good Quality Management System will provide a good foundation for meeting the requirements of the other standards and providing these standards are complied with, it is expected that the Department of Health and Family Services will provide the accreditation certificate.