1、DedicationThis book is dedicated: to my wife, Margaret to three daughters and three sons-in-law Alison and JohnHelen and AnthonyCaroline and Karland to eight grandchildrenThomas, Lucy, Sophie and EmilyHarriet and AlexanderJessica and Rebecca vThe right of Dr Dennis Green to be identified as author o
2、f this work has been asserted in accordance with the Copyright,Designs and Patents Act 1988. British Standards Institution 2005Copyright subsists in all BSI publications. Except as permitted under the Copyright, Design and Patents Act 1988, no extractmay be reproduced, stored in a retrieval system o
3、r transmitted in any form or by any means electronic, photocopying,recording or otherwise without prior written permission from BSI. If permission is granted, the terms may include royaltypayments or a licensing agreement. Details and advice can be obtained from the Copyright Manager, BSI, 389 Chisw
4、ickHigh Road, London W4 4AL, UK.Great care has been taken to ensure accuracy in the compilation and preparation of this publication. However, since it isintended as a guide and not a definitive statement, the author and BSI cannot in any circumstances accept responsibility forthe results of any acti
5、on taken on the basis of the information contained in this publication nor for any errors and omissions.This does not affect your statutory rights.BSI reference: BIP 2072ISBN 0 580 45645 5Typeset by Typobatics LtdPrinted by The Charlesworth GroupTable of ContentsPreface xi Chapter 1: General Introdu
6、ction 1Statutory requirements 2ISO 9001 quality management systems 2Residential care homes and the quality management systems standard 4The product and services of a residential care home 5Quality assurance 5The way forward 5Chapter 2: Residential care home documentation 7Policy documents 7Processes
7、 and process diagrams 8Procedures 8Work instructions 9Forms 9External documents 9External forms 9Home records 9Quality management systems documentation 10Chapter 3: Process diagrams 11Process diagrams for a residential care home 11Notes attached to processes 12Lower-level processes 12Advantages of p
8、rocess diagrams 12Bureaucracy 12Chapter 4: Quality management systems (clause 4) 21General requirements 21Documentation requirements 22viiQuality of Care in Residential Homes for the ElderlyChapter 5: Management responsibility (clause 5) 27Management commitment 27Customer focus 28Quality policy 28Pl
9、anning 29Responsibility, authority and communication 30Management review 31Chapter 6: Resource management (clause 6) 37Provision of resources 37Human resources 37Infrastructure 38Work environment 39Chapter 7: Product realization (clause 7) 41Planning of product realization 41Customer-related process
10、es 42Design and development 43Purchasing 44Production and service provision 46Control of monitoring and measuring devices 52Chapter 8: Measurement, analysis and improvement (clause 8) 55General 55Monitoring and measurement 55Control of nonconforming product 58Analysis of data 59Improvement 59Chapter
11、 9: Guideline audit questions 61Introduction 61Quality management system (clause 4) 62Management responsibility (Clause 5) 66Resource management (Clause 6) 72Product realization (Clause 7) 74Measurement, analysis and improvement (Clause 8) 84Appendix 1: Quality management system mandatory procedures
12、 91PC 101 Control of Documents 93PC 102 Control of Records 103PC 103 Internal Audit 107PC 104 Control of Nonconforming Product 117PC 105 Corrective Action 123PC 106 Preventive Action 129viiiAppendix 2: ReferencesFigures and forms 135Figure 3.1 A simple process 13Figure 3.2 A process showing consecut
13、ive activities 13Figure 3.3 PD 101 with attached note (statement of purpose) 13Figure 3.4 Care plan diagram 1 (PD 102) 16Figure 3.5 Care plan diagram 2 (PD 102) 17Figure 3.6 Procedure on medication (PD 103) 18Figure 3.7 Complaints procedure (PD 104) 19Figure 4.1 Quality management system documentati
14、on 26Figure 5.1 Organizational chart 33Quality Policy 35Quality Objectives 36FM 101 Control of Framework Documentation 98FM 102 Acceptance of Documentation 99FM 103 Register of Framework Documentation 100FM 104 Framework Documentation Change Request 101FM 105 Changes to Framework Documentation 102FM
15、 121 Internal Audit Schedule 111FM 122 Register of Internal Audits 112FM 123 Internal Audit Questionnaire 113FM 124 Nonconformity or Observation Form 114FM 125 Internal Audit Report 115FM 131 Register of Nonconformities 121FM 132 Nonconformity Form 122FM 141 Register of Complaints 127FM 142 Complain
16、t Form 128Quality of Care in Residential Homes for the ElderlyixPrefaceThe idea of writing a book on the application of the ISO 9001:2000 quality managementstandard to care homes for the elderly arose shortly after I had audited such a home, whilstbeing monitored by someone from the United Kingdom A
17、ccreditation Service (UKAS) andsomeone from the Education Department of the Social Care Association. I had done anenormous amount of preparatory work for the certification audit. As lead auditor, when Ichaired the closing meeting I recommended that the home should be awarded a certificateand the hom
18、e subsequently received it.I had carefully documented all the work that I had done in my own time before the audit.These documents were based on the study of several key documents: The Care HomesRegulations 2001, including a number of schedules, Care Homes for Older People: NationalMinimum Standards
19、 and The Management of Medication in Care Services.When I integrated the key aspects of these documents with what I knew about therequirements of ISO 9001, I had produced a large set of notes. All this work was necessarybecause one of the requirements of ISO 9001 is that all regulatory and statutory
20、 requirementshave to be addressed satisfactorily. At end of the day I was satisfied that the home did, in fact,from the objective evidence that I found, satisfy all such requirements and the requirements ofthe ISO 9001.My experience convinced me that I should write this book, especially since no one
21、, as far as Iknew, had written on this important subject.Chapter 1 provides background reading that is essential to set the scene, including the relevantregulatory and statutory documents. Chapter 2 classifies the different kinds of documents that ahome might decide to use. A few are mandatory, such
22、 as the quality policy, but otherwise thehome can decide what documentation it needs to run the home efficiently in the best interestsof the residents in which quality of care is paramount. It is advisable to classify documents.One way is suggested by the examples given in Chapter 2, but the home ca
23、n choose whateverway seems best.Chapter 3 is devoted to process diagrams. Process diagrams are explained and several flowdiagrams are included as examples. Note that process diagram PD 102 (Figures 3.4 and 3.5) isin the form of a traditional diagram whereas PD 104 (Figure 3.7) is a more modern diagr
24、amproduced by more sophisticated computer software. The home is free to decide which methodto use.Chapters 4 to 8 address the requirements of the corresponding clauses of ISO 9001. xiQuality of Care in Residential Homes for the ElderlyChapter 7, Product realization, comments on requirements that rel
25、ate to applicableregulations, schedules and standards associated with care homes. These have been identifiedfor the reader in the relevant places.Chapter 7 is exceptional in that parts of it need not be addressed, provided any exclusions canbe justified and the exclusions are explained in the qualit
26、y manual. Chapter 9 is devoted to guideline audit questions. Questions that are particularly relevant toregulations and standards are printed in italics. Appendix 1 includes the six mandatory procedures required by ISO 9001. These are: controlof documents; control of records; internal audit; control
27、 of nonconforming product; correctiveaction; and preventive action.The book also includes a typical quality policy that addresses the requirements of ISO 9001, astatement of possible quality objectives and a suggested organization chart. Appendix 2 gives alist of references.This book should be of sp
28、ecial interest to many people who have responsibility for the care ofelderly people in residential care homes and who want to maintain and, whenever possible,improve the quality of life of the residents through a quality management system based on theinternational standard ISO 9001.It is hoped that
29、this book will benefit many different kinds of manager. First I hope that it willbe of interest to what the standards refer to as top management. These are people who directand control organizations. For the first time an external auditor from a certification body isexpected to make a judgement on w
30、hether there is a commitment by top management to itsquality management system. A committed top manager is more likely to create a new culturein which corporate competence and individual competence are at the forefront of all levels ofmanagement and the workforce. The book should also be of interest
31、 to quality professionals as well as to those who aspire tobecome one. This includes internal auditors and third-party auditors. The views expressed are those of the author. The author is confident that if the guidelinesincluded in this book are followed, in interpreting the five requirement clauses
32、 of ISO 9001and the regulations and standards applicable to residential care homes, the home is likely toachieve accredited certification to ISO 9001 at the first attempt. Perhaps what is much moreimportant is that the quality of care of all the elderly residents in such a home will thereby beenhanc
33、ed. It would be impossible to thank personally all those who have made this book possible. Muchof the book is based on my experience as an auditor, mainly auditing against the qualitymanagement standards on behalf of certification bodies. I should like to express my thanks tothese certification bodi
34、es, which have provided me with many opportunities for third-partyauditing. I should also like to thank the people in many organizations whom I have subjectedto the rigours of third-party auditing. All the people that I have met at different levels withinsuch organizations have, without exception, r
35、eceived me kindly into their organizations toenable me to carry out my duties. Without such acceptance, auditing would have become anunwelcome task and one that I would have abandoned a long time ago.xiiChapter 1: General introductionThe age distribution of the UKs population has been changing over
36、the last few decades. Thisis partly because people are having fewer children. The other reason is that modern medicineand surgery are now based on scientific and technological developments that enable doctors totreat patients in ways that were inconceivable a few decades ago. As a result, many patie
37、ntswith what used to be life-threatening diseases or conditions recover and live much longer thanthey did previously. Amongst the ever increasing number of elderly people, whether they have been in hospital ornot, there are some who need support for day-to-day living in their own homes. This isparti
38、cularly the case when there is no longer a partner to act as carer. This situation isaggravated when children of the elderly people are unable to give much day-to-day supportbecause they have other responsibilities, however much they would like to. It is because someelderly people need to be cared f
39、or in their homes that a caring services industry has beendeveloped over the last few years in which home carers now visit elderly people in theirhomes on a regular planned basis to give them personal care and domestic help. Manythousands of elderly people now receive help in their own homes. Some h
40、undreds ofdomiciliary home care organizations have been established to provide such care. Elderly people need additional nursing care that used to be provided in hospital. It is becauseof the increasing demands being made on the National Health Service hospitals for thediagnosis and treatment of ill
41、nesses that long term nursing of elderly people in our hospitals isno longer an option. As a result there are now many nursing care homes or care home, N (Nstanding for nursing) throughout the country for elderly people, where residential care withappropriate nursing is provided.There are other new
42、types of classification for care homes, e.g. DE means that the care homespecializes in dementia care; MD stands for mental disorder; PD for physical disabilities.There is another possible provision for elderly people: the residential care home, or carehome, PC (PC standing for personal care). Such h
43、omes provide all the basic needs of elderlypeople whose nursing needs are minimal, in a safe and caring environment. In these homes,whenever a nursing or medical need arises then such needs are provided by externalresources, such as community care nurses and general practitioners. According to a rec
44、ent National Care Standards Commission (NCSC) report 1, there are22,836 social care establishments registered on their database. These include care homes for1Quality of Care in Residential Homes for the Elderlyelderly people; care homes for younger adults; and childrens homes. A recent Which? report
45、2 states that the Office of Fair Trading has been persuaded to investigate the 9 billionpounds a year care homes market.Statutory requirementsFollowing the Care Standards Act, 2000, the National Care Standards Commission (NCSC) wasestablished. On 1 April 2004, this commission was replaced by the Com
46、mission for Social Careand Inspection (CSCI). This new inspectorate brings together the social care functions of theformer NCSC; the work previously undertaken by the Social Services Inspectorate; the jointReview Team of the Social Services Inspectorate; and the work of the Audit Commission.All care
47、 homes must abide by the Care Homes Regulations published in 2001 by the formerNCSC 3. These regulations came into force on 1 April 2002. The Regulations are mandatory.There are 46 regulations supplemented by seven schedules.In February 2003, the Department of Health published the third edition of t
48、he Care Homes forOlder People: National Minimum Standards 4. It became effective on 1 June 2003. There are38 national minimum standards: Standards 16 Choice of home;Standards 711 Health and personal care;Standards 1215 Daily life and social activities;Standards 168 Complaints and protection;Standard
49、s 1926 Environment;Standards 2730 Staffing;Standards 3138 Management and administration.These standards have no statutory powers, but are similar to codes of practice. The failure toaddress some or all of the national minimum standards is not likely to go unnoticed byinspectors. Compliance with such codes is a positive factor when members of the inspectorateare determining whether a residential home meets the needs, and secures the welfare andsocial inclusion of the people who live in such homes. However, f
