HEALTHMARK MAKING QUALITY VISIBLE ISO 9001:2000 / HEALTHMARK. Guidance Notes for Nursing and Residential Care Home and Domiciliary Care Providers

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1 HEALTHMARK MAKING QUALITY VISIBLE

2 FOREWORD WHAT IS ISO 9001:2000 (hereafter referred to as the standard ) It is the latest revision of a quality management standard which has been used by organisations around the world for many years. The standard defines quality management system requirements for organisations which need to demonstrate their ability to: Provide a consistent service which meets client, as well as applicable regulatory and statutory requirements. Address client satisfaction and proactively use the information obtained to shape the service for the future and demonstrate continual improvement. The standard is based on eight quality management principles: Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision-making Mutually beneficial supplier arrangements CONTENTS PAGE NUMBER INTRODUCTION...4 DEFINITIONS...5 SCOPE OF THE APPLICATION...6 QUALITY SYSTEM REQUIREMENTS GENERAL REQUIREMENTS MANAGEMENT RESPONSIBILITY RESOURCE MANAGEMENT SERVICE REALISATION MEASUREMENT, ANALYSIS AND IMPROVEMENT 16 CERTIFICATION PROCESS...19 HOW TO START...19 CERTIFICATION AUDIT...20 DOCUMENTATION REVIEW...20 ASSESSMENT TEAM...20 HEALTHMARK Healthmark is a branded ISO 9000 quality management certification process for the Health and Social Care Sector. It is provided by SGS United Kingdom Ltd. The benefits of bespoke ISO 9000 certification ensure that assessments are undertaken by auditors with appropriate skills and expertise. In addition, care organisations achieving ISO 9000 certification under the scheme can display the Healthmark logo, a visible demonstration of their commitment to quality. SGS United Kingdom Ltd supports Health and Social Care clients with a range of guidance notes and bespoke training courses. ON-SITE ASSESSMENT...20 REFERENCE MATERIAL...21 Copyright SGS United Kingdom Ltd 2001 All rights reserved. No part of this publication may be copied, reproduced or transmitted in any form or by any means without the written permission of SGS United Kingdom Ltd Published by SGS United Kingdom Ltd

3 INTRODUCTION DEFINITIONS The Care Standards Act 2000 and the National Minimum Standards for Care Homes for Older People require all care homes to implement a recognised quality system. ISO 9001:2000 the international quality management standard, used by over 400,000 organisations throughout the world, is recognised as meeting the requirements defined in Standard 33 of the Minimum Care Standards. This guidance note is intended to assist care providers in the interpretation and implementation of ISO 9001:2000 Quality Management Systems. This document is not intended to replace, repeat, or amend the ISO 9001:2000 standard. This guidance note should be used in conjunction with the ISO 9001:2000 and the National Minimum Standards for Care Homes. The aim of this document is to provide a practical approach to quality management system implementation and for ease, follows the clause numbers for the standard. It is also the intention of this document to include, where possible, and to equate to the elements from the National Minimum Standards. By doing this, users of this note should be able to implement a quality management system which meets not only the requirements of Standard 33, but takes into account the seven key topics upon which the care of older people is based: Choice of home Health and personal care Daily life and social activities Complaints and protection Environment Staffing Management and administration Where they appear in the text, the following definitions apply. QUALITY Quality is a fitness for purpose or the degree to which a set of inherent characteristics fulfils requirements. This will include all the activities within the home-client processes such as enquiry, assessment, admission, care planning, provision of care and care review. In addition, it will take into account activities and resources which impinge on care provision and without which, care could not be provided. These include staff, training, purchasing, catering, domestic services, maintenance and infection control. QUALITY ASSURANCE Part of the quality management system which provides confidence that stated or implied requirements are being met. Quality assurance is about deciding what needs to happen, setting a standard, and ensuring that that standard is consistently met. THE CARE HOME An establishment providing accommodation with nursing or personal care, that is, the provider of the service. THE PURCHASER The purchaser of the service, that is, the client, the client s family, the local authority, the health authority and one who purchases the service on behalf of the client. THE CLIENT Also referred to as the service user, patient or resident. THE STANDARD ISO 9001:2000, standard for quality management systems. THE ORGANISATION Care home, residential home, nursing home, or domiciliary care Provider

4 SCOPE OF THE APPLICATION The scope of this guidance note deals with the application of ISO 9001:2000 to care homes and though it is specific to the requirements of residential and nursing care homes for older people, it can generally be applied to care provision for mental health, learning difficulties and domiciliary care providers. QUALITY SYSTEM REQUIREMENTS The clause numbering and sub-clause heading in this document match those in ISO 9001:2000. Where applicable, reference is also made to the National Minimum Standards for Care Homes for Older People. 4.GENERAL REQUIREMENTS Implementation and maintenance of a quality management system allows the organisation to be managed in a systematic and visible way. This requires the organisation to identify the processes or activities they undertake in order to deliver the service they provide. Example Receiving enquiries, care assessment, contracting processes, admission process care planning, care provision processes, care review, discharge/care of the deceased, human resource processes including recruitment induction and training and monitoring and evaluation activities. Support activities such as catering, hotel services, maintenance. In addition, the organisation needs to consider what resources it needs to ensure that it is able to deliver that service. Resources include staff and information as well as monitoring processes to ensure that the service is provided in the way in which the organisation determines that it should. Finally, the quality management system should ensure that by using monitoring and evaluation information it is able to continually improve the service it provides. 4.2 Documentation Requirements General The organisation needs to define the documentation, including policies, procedures, objectives and records it needs to deliver the service, taking into account the requirements of the international standard as well as those documents required by the care home for planning, operating and control. As a minimum, the care home will be required to have in place the six quality system procedures outlined in the standard. Control of documents Control of records Internal audit Control of non-conforming product (service) Corrective action Preventive action In addition, the National Minimum Standards for Care Homes outlines a requirement for the following policies and procedures: Complaints procedure Medication policy Medication procedures Policies and procedure for handling dying and death Policy on maintaining relatives and friends involvement Protection policies Procedure for responding to suspicion/evidence of abuse or neglect Whistle-blowing policy Policies and procedures for control of infection Recruitment procedure Accountant and financial procedures Employment policies and procedures Record-keeping policies and procedures Safety procedure

5 4.2.2 Quality Manual The quality manual should include the scope of the quality management system. Example Provision of nursing and residential care for the elderly and infirm. (N.B. where the organisation intends to exclude any elements of the standard this should be documented in the quality manual and are limited to clause 7.) The manual should include a description of processes, their interaction and related procedures or reference to them, and any exclusions Control of Documents A procedure is required detailing how documents are approved, issued and reviewed and status and ownership identified. The procedure should also outline a system to prevent the use of obsolete documents. In addition the procedure should allow the identification, control and use of external documents. External documents would include, for example, Clinical Guidelines, Department of Health (DoH) documents, Health Service Guidance (HSGs), documents (see National Minimum Standards for Older People) and international standards Control of Records A procedure is required to identify and define the controls needed for storage, protection, retrieval, retention and disposition of records. Records in care homes would include as a minimum, patient/client records, staff records, medication records, maintenance records, financial transactions, records and receipts of possessions, service user surveys, procedures, audit records and inspection records. Consideration should also be given to the security of patient identifiable information in line with the requirements of the Caldicott Report. (N.B. records can be hard copy or electronic data.) 5. MANAGEMENT RESPONSIBILITY 5.1 General The standard requires top management to provide evidence of its commitment to the development, implementation and continual improvement of the quality management system, ISO 9000:2000 section defines top management as a person or group of people who direct and control an organisation at the highest level. In the case of a care home this would be the matron, manager and/or for a large care home group management commitment would extend to the management board and directors. The commitment of top management should extend to ensuring that the organisation is customer focused, that statutory and regulatory requirements are met, that appropriate and adequate resources are available, that a quality policy and quality objectives are established and communicated and that the quality management system is reviewed to ensure continuous improvement. Standard 32 of the National Minimum Standards echoes these requirements calling for a clear sense of direction and leadership, with staff and service users able to relate to the aims and purposes of the home, and strategies enabling staff, service users, and stakeholders to effect delivery and development of the service. 5.2 Customer Focus Management need to ensure that customer needs are determined and met (customer satisfaction is covered in more detail under clause 8). Customers in this instance can also include stakeholder, so not simply the patient/service user, but family and purchasers. 5.3 Quality Policy The organisation needs to establish a quality policy. The quality policy should include a commitment to comply with relevant requirements and continual improvement and be a framework for establishing quality objectives. It is essential that the quality policy is owned and understood by all staff. The quality policy could include, or make reference to the statement of purpose. Standard 1 of the National Minimum Standards requires care homes to produce a statement of purpose setting out aims and objectives, philosophy of care, services and facilities and terms and conditions. Organisations are required to review the quality policy for continual suitability

6 5.4 Planning Quality Objectives Top management should establish quality objectives in line with the quality policy. The purpose of setting quality objectives is to ensure continual service improvement. It is essential that objectives are measurable. Objectives may be set for the organisation as a whole, devolved to individuals for action and linked to the annual development plan required in Standard 33 of the National Minimum Standards Quality Management System Planning The organisation needs to ensure that the integrity of the quality management system is maintained when changes are made. 5.5 Responsibility, Authority and Communication Responsibility and Authority The responsibilities and authority of all staff should be determined. This may be in the form of job descriptions and organisational charts. National Minimum Standard 31 outlines responsibilities, qualifications and experience for registered managers Management Representative The organisation needs to appoint a member of staff who, irrespective of other duties, is responsible for the implementation and maintenance of the quality management system. Other responsibilities include reporting to top management on the performance of the quality management system and ensuring promotion of client satisfaction. In most care homes this will not constitute a full-time role but be part of another role. It is essential that the quality management representative is credible within the organisation. Large care home groups may appoint a quality manager who liaises with/supports a representative in each home Communication 5.6 Management Review To ensure the continued suitability and effectiveness of the quality management system, the organisation is required to undertake reviews at planned intervals. Records of management system reviews, e.g. minutes of meetings, should be kept. The standard is specific about what input should be included in the review - at a minimum, consideration should be given to results of audits, customer feedback, performance, status of corrective and preventive actions, follow up from previous review meetings, changes and recommendations for improvement. In addition, care homes would bring to management review National Care Standards Commission (NCSC) inspection reports and results of service user surveys. Output of management review should include actions related to improvements and resource needs. 6. RESOURCE MANAGEMENT 6.1 Provision of Resources Top management need to ensure that adequate and appropriate resources are available. Resources include staff, infrastructure, environment, information, suppliers and financial resources. 6.2 Human Resources The organisation needs to ensure that staff are competent on the basis of appropriate education, skills and experience. There should be processes in place to determine competence, provide training and evaluate the effectiveness of training. The organisation needs to maintain appropriate training records for staff. In addition, the organisation needs to take into consideration staffing numbers and skill mix outlined in National Minimum Standards as well as implementing a staff training and development programme which meets National Training Organisation (NTO) workforce training targets. All care staff should have formal supervision at least six times a year. Appropriate communication systems should be established. This may take the form of staff meetings, newsletters, communication sheets, and noticeboards

7 6.3 Infrastructure The organisation should determine, provide and maintain the infrastructure required to provide the service. This includes buildings, equipment and utilities. Standard 5 of the National Minimum Standard outlines Environmental Standards required for care homes and should be used in conjunction with this standard. (N.B. Where there is a long lead time, e.g. compliance not required until April 2007, non-compliance prior to that date would not preclude the organisation from achieving ISO 9001:2000.) 6.4 Work Environment The organisation needs to ensure that the work environment is conducive to staff safety and provision of the service. In the main, by meeting the requirements of the Environmental Standard, care homes would meet this requirement. However, consideration should be given to provision of staff as well as client facilities. The provision of personal protective equipment should also be considered with regard to infection control requirements. Staff should be trained in manual handling and the use of lifting equipment and hoists. 7. SERVICE REALISATION 7.1 Planning Service Realisation Service realisation relates to the core activities and where required/applicable procedures of the organisation, in this case, the provision of care/service. The following is a brief outline of care processes and the activities which are required to support it. N.B. This chart on the opposite page is not intended to be exhaustive but is to demonstrate activities which should be subject to control within the quality management system. The organisation should consider the need for documents, records and monitoring required in respect of the above. A document specifying the processes of the quality management system can be deemed a quality plan. Staff Recruitment Induction Training Finance Purchasing Provision of Outsourced Services eg: GP Community Nursing 7.2 Customer Related Processes Enquiry Assessment & Contracting Admission Care Planning & Review Provision of Care & Associated Care Procedures Transfer, Care of the Deceased Catering Provision of Equipment Maintenance of Building & Equipment Hygiene Laundry The organisation needs to determine client requirements prior to agreement to provide the service. Requirements of service provision are agreed subject to client requirements, statutory and regulatory requirements and the needs of the stakeholders Reviews of Requirements Related to the Service This covers the contracting process and can include contract with the individual resident, purchaser or care package provision. National Minimum Standard 2 defines the requirements of written contracts. The contracting process should include a review process

8 7.2.3 Customer Communication The organisation needs to have effective arrangements in place to communicate with clients in respect of information available about the home, dealing with enquiries and customer feedback, including complaints. National Minimum Standards state the need to provide a service user guide which includes information about accommodation and service staff, results of inspection reports, a copy of the complaints procedure and service users views of the home. 7.3 Design and Development For care homes, this relates to the development and review of care plans, pathways of care and care packages. The following plan links the clauses of the standard with the care planning and review process Care Planning Needs assessment Input Care plan produced based on the care management assessment and resources available. Agreed by client Output Care plan meets the needs of client, information available to client, management and those providing the care Review Care plan reviewed at defined periods and when needs arise. Problems identified Verification Confirmation of objectives achieved should be recorded Validation Record review and confirm the plan still meets client needs or agree changes. 7.4 Purchasing The organisation should have in place robust systems for controlling purchasing. This should include evaluation of suppliers of products and services. Purchasing information would include, for example, purchase orders, shopping lists, and delivery notes. Verification of purchased products should also include evaluation of provision of services purchased and services provided by agency staff. Records should be kept of all transactions. Where service users money is used, the organisation should ensure it meets the requirements defined in Standard 35 of the National Minimum Standards with regard to written records and receipts. 7.5 Service Provision Care should be provided in line with statutory and regulatory requirements, taking into account the needs and wishes of the clients defined care plans, evidence-based best practice and using appropriate equipment, facilities and staff. Written procedures should be available as stated in the National Minimum Standards, ISO 9001:2000 and as required by the organisation depending upon the skills, training and knowledge of the staff providing the service. Where homes use specific care models, research based nursing procedures such as The Royal Marsden, they can be referenced in the quality management system Validation of Service Provision Validation or record of care provision will be recorded in individual client records as defined in record-keeping policies and procedures Identification and Traceability The organisation needs to consider identification of residents and records, identification and traceability of medication and food. In addition staff should be traceable, client records should be signed, appropriate qualifications verified and staff rotas should be retained Changes Record new objectives

9 7.5.4 Customer Property This can be divided into physical property and intellectual property. Intellectual property can be the information that the client provides to the home, nurse or social worker in order for them to develop a plan of care. Client property including money should be recorded, receipted and safeguarded in line with requirements defined in Standard 35 of the National Minimum Standards Preservation of (Product) Consideration should be given to the identification, handling, packaging, storage and protection of medication and foodstuffs. In addition, residents should be housed in an environment which meets the requirements outlined in the National Minimum Standards (it should be noted, however, that some of the environmental standards do not require compliance until this would not preclude the organisation from achieving ISO 9001:2000 certification). Residents should be treated with care, courtesy, dignity and respect at all times and consideration given to the use of equipment and training of staff when lifting and moving residents. 7.6 Control of Monitoring and Measuring Devices This relates to the care, maintenance, servicing, and where appropriate, calibration of the equipment used in the provision of the service. Test equipment can include sphygmomanometers, glucometers, thermometers, food probes, oxygen regulator, resuscitation equipment, I.V. fluid counters and pumps and may require calibration or verification at specified intervals. Portable appliance safety testing should be carried out and all equipment identified. Lifts and hoists, fire safety and alarm bells should all be subject to appropriate control. 8.2 Monitoring and Measuring The organisation should determine a method for seeking views of service users. National Minimum Standards require homes to publish the results of service user surveys and make them available to current and prospective users. In addition feedback should be actively sought, possibly through anonymous user satisfaction questionnaires and individual and group discussion Internal Audit The organisation needs to have in place a documented procedure which defines responsibilities and requirements for planning and conducting audits, a mechanism for reporting and recording results and methodology for ensuring that where problems are identified corrective action is taken. In addition there should be a process to verify corrective action. The organisation should ensure that staff undertaking audits are appropriately trained and independent of the activity being audited Monitoring and Measurement of Processes This could be undertaken through the internal audit process, as defined in procedures. In addition, inspection visit reports and action plans and staff supervision processes defined in the National Minimum Standards can be included as monitoring processes Monitoring and Measurement of Product (Service) Generally this would refer to care or service provision as the product, which is monitored through the care plan, ensuring that the outcome meets residents assessed needs. 8. MEASUREMENT ANALYSIS AND IMPROVEMENT 8.1 General Requirements Having defined how the organisation should operate, there is a need to monitor to ensure that the service is provided as stated. In addition, information should be sought and analysed to assist in continually improving the service

10 8.3 Control of Non-conforming Product (Service) A documented procedure is required here, to define how the organisation ensures that non-conformances are identified, action taken and lessons learned to prevent recurrence. Non-conformances can range from dealing with faulty supplies and equipment to major lapses in service provision. Procedures would include how to deal with critical/clinical incidents as well as inappropriate staff behaviour. National Minimum Standards call for policies and procedures to cover: Responding to suspicion/evidence of abuse or neglect Whistle-blowing policy Protection policies Medication procedures should include how to deal with medication errors. 8.4 Analysis of data The organisation should collect and analyse data to evidence the effectiveness of the quality system and to evaluate continual improvement. Analysis of data should provide information about satisfaction, meeting service requirements, e.g. care outcomes, bed occupancy, inspection reports and supplier information. 8.5 Improvement Continual improvement should be demonstrated by following the principles of the quality policy and philosophy of care, meeting objectives and using analysed data to enhance the service provided Corrective Action A documented procedure is required to demonstrate how the organisation will deal with non-conformities in order to prevent recurrence Preventive Action A documented procedure is required to demonstrate how the organisation prevents problems. This should include near-miss reporting, risk management activities and risk assessment. CERTIFICATION PROCESS HOW TO START Most homes will probably already have in place much of what is required to provide the basis of a quality management system. Trained, competent staff, the infrastructure, care processes and some policies and procedures. The first step is to undertake a gap analysis or review against the requirements of the standard and determine what is needed to bring together what already exists into a robust quality management system. Staff need to be identified to undertake the development of the system and that requires the commitment of top management. Some organisations may wish to employ outside consultants to assist in initial system development. Once the quality management system has been developed it should be implemented and owned by staff and audited to ensure its effectiveness. ISO 9001:2000 quality management systems are not necessarily heavily paper driven. However some documentation is required. Quality Manual A top level document containing: An over view of the organisation Defining the scope of the QMS The quality policy and links to objectives An interpretation as to how the organisation meets the clause of the standard Provides links to to the QMS procedures Policy and Procedures Manual QMS Procedures Control of documents Control of Quality Records Internal Audit Control of Non-Conformance Corrective Action Preventive Action Organisation Specific Procedures Care and service procedures defined in National Minimum Standards plus any other procedures the organisation deems necessary to assure the quality of service provision. Supporting Documentation and Controlled Forms e.g: Patient Records Training Records Drug Records Purchasing Documents Minutes of Meetings Audit Reports Complaints Forms Customer Satisfaction Forms Client Information Leaflets Supporting work instructions if required

11 CERTIFICATION AUDIT Certification audit is a two-phased process starting with a: DOCUMENTATION REVIEW This can take the place at the home or off site, and involves the certification body s auditor assessing the documented quality system against the requirements of the standard. Following this, the home will receive a report outlining any deficiencies. These deficiencies must be rectified before the on-site assessment. Checklists are produced and an itinerary will be forwarded outlining the format of the assessment and detailing the assessment team. ASSESSMENT TEAM The number of auditors is determined by the size of the home. Auditors will have a background, or be experienced in auditing, in the health and social care sector. ON-SITE ASSESSMENT The assessment begins with an opening meeting and an introduction to the audit team; the assessment process includes major and minor corrective action requests and the need for openness and honesty. This will be introduced by the lead auditor who will also outline the certification body s confidentiality policy. Top management of the home will be expected to give a brief presentation outlining the organisation, the development of the quality management system and the quality objectives. The assessment then takes the form of semi-structured interviews with staff at all levels of the organisation, observations of records and other documentary evidence to assess compliance with procedures. The process ends with a closing meeting and depending upon the level of compliance, a recommendation for certification. Following successful assessment and authorisation of the report, a certificate is awarded and the organisation becomes eligible to be entered onto the Q.A. register and to use appropriate certification marks and logos. Six-monthly or annual surveillance audits are scheduled to ensure continued compliance with the standard and the organisation s procedures and to ensure continual improvement. Implementing an ISO 9001:2000 Quality Management System is a way to effectively manage the organisation in line with, and meeting the requirements of, the National Minimum Standards for Care Homes for Older People. REFERENCE MATERIAL United Kingdom Central Council (UKCC) (1992) Standards for the Administration of Medicines, London: UKCC. Burton, J (1998) Managing Residential Care, London: Routledge. Health and Safety Executive (1993) Health and Safety in Residential Care Homes (HS(G) 104), Sudbury: Health and Safety Executive. Centre for Policy on Ageing (1996) A Better Home Life: A Code of Good Practice for Residential and Nursing Home Care, Report of an Advisory Group convened by the Centre for Policy on Ageing under the chairmanship of Kina, Lady Avebury, London: Centre for Policy on Ageing. Department of Health (1989) Homes are For Living In: A Model for Evaluating Quality of Care Provided, and Quality of Life Experienced, in Residential Care Homes for Elderly. Social Services Inspectorate, London: HMSO. Department of Health (1998) Modernising Social Services: Promoting Independence, Improving Protection, Raising Standards. London: HMSO. Department of Health (2000) Care Standards Act 2000, London: HMSO. Care Homes for Older People National Minimum Standards, Department of Health. ISO 9001:2000 Quality Management System Requirements. ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary. ISO 9004:2000 Quality Management Systems - Guidelines for Performance Improvement. This guidance note has been developed by: Sheila Oliver RGN, MSc, FIQA, Healthmark Manager for SGS United Kingdom Ltd

12 THE SGS GROUP The SGS Group of companies is the world s largest organisation in the field of inspection, verification, testing and certification. The Group comprises more than 300 affiliated companies, each separately organised and managed in accordance with the laws and local practices of the countries in which it does business. Founded in 1878, it has expanded across the world, operating in over 140 countries, with over 1000 offices and laboratories and 46,000 employees. Since it was established, the SGS Group has remained dedicated to its independence as a guarantee of its total impartiality. SGS does not engage in any manufacturing, trading or financial activities which might compromise its independence and neutrality. SGS United Kingdom Ltd SGS House London Road Camberley Surrey GU15 3EY United Kingdom Tel: +44 (0) Fax: +44 (0) Sheila Oliver Tel: +44 (0) For copies of guidance documents visit

13 SGS 5247/0107

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