QMS ISO9000 in healthcare


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QMS ISO9000 in healthcare

  1. 1. ISO 9000 In Healthcare: A Guide To Its Implementation
  2. 2. INTRODUCTION Quality and customer satisfaction are key priorities for today’s most successful organizations. Where the market place is competitive, there are significant efficiency pressures, and consumer’s demands are increasing, success does not just happen. Attaining it requires commitment, buy-in, and the appropriate management system. While commitment starts with management, and depends upon the organization, several frameworks exist to assist in developing the management system. One such framework is the globally recognized ISO 9001:2000. ISO 9001:2000 is a standard, which provides organizations with a guide to achieving the goals of quality, and customer satisfaction. It has been successfully implemented by hundreds of thousands of organizations, in a wide variety of industries, with healthcare being no exception. BSI Management Systems itself has customers from a wide range of healthcare industries, including hospitals, medical practices, nursing homes, dentistry, oncology, ambulance services, and support services. This guide provides an overview of the application of ISO 9001:2000 to healthcare. The guide highlights significant opportunities to implement ISO 9001:2000, and subsequently become registered to the standard by a registrar like BSI Management Systems. THE USE OF QMS IN HEALTHCARE In recent years, quality and QMS have gained significant support in the healthcare industry in North America. While this has not always been the case, governments, regulators, industry bodies, healthcare providers, and support service organizations, are realizing that through implementing frameworks like ISO 9001:2000, they can improve quality and reliability, and increase efficiencies. This can mean an improved service, a reduction in adverse events, and ultimately a lower cost of provision. Organizations such as the JCAHO, Health Canada Accreditation, the American Society for Quality, the Institute of Medicine, the Canadian Council on Health Services, the Automotive Industry Action Group, the National Association of Manufacturers, and the Baldrige National Quality Program (National Institute of Science and Technology), have all identified quality, and customer service as important areas for improvement in healthcare.
  3. 3. BENEFITS OF USING A QMS ISO 9001:2000, derives a number of benefits for healthcare organizations, including: • Potential for efficiency gains and cost reduction: ISO 9001:2000 can create significant efficiency gains because of its process orientation. The standard focuses organizations upon areas where costs can be reduced, both internally, and in relation to its customers. • Potential for quality and reliability improvements: The process orientation, and the need to be customer focussed and continually improve, provide significant opportunities to increase the reliability, and quality of healthcare. ISO 9001:2000 provides opportunities to standardize the service throughout organizations, and the healthcare industry as a whole. • Potential for regulatory support and funding: Increasingly, regulators and legislators are regarding quality as vital to improving healthcare. Bodies such as the JCAHO, Health Canada, and Institute of Medicine have emphasized this. Registration may therefore lead to greater funding and support. • Potential to simplify the implementation of other quality systems: ISO 9001:2000 has the potential to make accreditation and conformity to other requirements much simpler. It has been regarded as a building block to JCAHO accreditation, and the Baldrige awards. • Potential for an improved care process: ISO 9001:2000 focuses organizations on the processes involved. In healthcare it can improve the organization’s understanding of the complexities of the industry, including the relationships between organizations such as hospitals and medical practices. • Potential for Differentiation: Registration differentiates an organization from its competition. It shows customers that the organization is committed both to their needs, and improving the quality of the service they provide. • Potential for continuous improvement: ISO 9001 stipulates the importance of review, and continual improvement. In healthcare, where these are paramount, registration can be beneficial. ISO 9001:2000 VERSUS ISO 9001/2/3:1994 Many people may be familiar with the 1994 version of ISO 9000, the forerunner to ISO 9001:2000. At the time however, they may have deemed it inappropriate for their organization. The successor, ISO 9001:2000, however contains a number of significant changes that should encourage a reassessment of the standard’s applicability. Two of the most significant changes are: A Process Approach: One of most significant principles (and most different from ISO 9001:1994) is the process approach. It is based on the idea that organizations should understand what they do, and the processes that affect this, that is the processes that result in the provision of a product or service. The standard focuses upon these processes and the interactions between them. Examples of this include the importance placed on supplier/customer relationships, the importance of input and outputs, and the likelihood that one output is an input for another process. Measurement, Analysis & Improvement: Since 1994, the importance of measurement, analysis, and improvement has been upgraded. It focuses organizations on the outcome and success of the management system. This helps your organization improve and conform to requirements within the industry.
  4. 4. THE CONCEPT ISO 9001:2000 The ISO 9001:2000 standard is a generic document, allowing for interpretation and implementation by both the manufacturing and service sectors. It focuses upon specific principles, which should be adhered to. The standard however affords a significant degree of freedom to develop a QMS, which suits the organization, as long as it conforms to these key tenets. ISO 9001:2000 PRINCIPLES • Customer focused organization • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationship One of most significant principles is the process approach (see box below). This focuses the organization on what it does. The process approach links business objectives and results more closely. The standard is based around the core concept of Plan-Do-Check-Act, and focuses the organization on the processes, which are key to its operation. It also builds in the ideas of planning, and reviewing, and the fact that organizations should strive to continually improve Source: BS EN ISO 9001:2000
  5. 5. ISO 9001:2000 & HEALTHCARE The principles and structure of ISO 9001:2000 mean it can be applied to healthcare, as easily as it has been applied to the manufacturing industries in the past. More specifically it can be implemented by any organization in any sub-segment, regardless of their size. It is applicable to hospitals, and medical care facilities, as well as support services, such as laundry and cleaning. THE HEALTHCARE PROCESS Generically, healthcare is based around the care of the patient, with an organization’s typical goal being to ensure the effective passage from the patient’s enquiry through to their discharge, and their subsequent satisfaction. APPLICATION OF THE ISO 9001:2000 CONCEPT TO HEALTHCARE ISO 9001:2000 promotes a focus on the customer, and their satisfaction from the service provided. In healthcare, this is often regarded as the patient. However, there are several other stakeholders that are customers. This includes the automotive manufacturers and other organizations that pay for health insurance, the health insurance companies themselves, families, and other healthcare providers. Taking the approach that the patient is the primary customer, the Plan-Do-Check-Act principle can be applied as follows: At a generic level, the diagram highlights some of the processes involved in healthcare. More specifically, these might include: While this highlights some of the processes that may occur, there are many more organizationally specific processes, which should be considered. Source: The Process Practice Ltd Source: The Process Practice Ltd
  6. 6. ISO 9001:2000 SPECIFIC CLAUSES The following gives an overview of how specific clauses in ISO 9001:2000 can be applied to healthcare. It concentrates on specific issues, which are of relevance, and provides examples. CLAUSE 4 – QUALITY MANAGEMENT SYSTEM A core requirement of the standard and subsequently of importance to healthcare organizations is the need to develop (and implement) a QMS, which defines the processes in the organization, and how these relate. The clause also requires that the organization has documentation (which you must control). Within healthcare, much of this may already exist in the form of externally generated literature, such as standard laboratory operating procedures, and regulatory requirements. When looking at relevant processes, the organization must consider outsourced processes, such as cleaning and laundry services. The documentation, which might need to be controlled, includes: • Quality Manual • Patient/Health Records CLAUSE 5 – MANAGEMENT RESPONSIBILITY As with other organizations and industries, the QMS must have the support and commitment of top management. They should be involved in setting the quality policy, and measurable objectives, and should consider the requirements of stakeholders (customer focus) including any social needs. To achieve the above, planning is vital. Plans may already exist for example concerning patient care, emergency and disaster management, and security. ISO 9001:2000 requires that management review the QMS. Information might include: • Patient feedback and complaints • Results of Audits • Reports from other stakeholders, such as insurance companies, and doctors CLAUSE 6 – RESOURCE MANAGEMENT To satisfy patient requirements, and continually improve the organization, identification, and the provision of the necessary resources is essential. This should cover people, infrastructure and the environment. This may involve, training staff, maintaining buildings and equipment, and ensuring a safe working environment. DOCUMENTS OF INTEREST: • HB 10202:2002 – A Guide for the Adoption of ISO 9001:2000 in Healthcare: A guidance document sold by BSI Business Information for implementing ISO 9001:2000 in healthcare organizations. Available through www.bsonline.techindex.co.uk Information relating to the application of ISO 9001:2000 in healthcare has been adapted from this document. It was written by The Process Practice Ltd. • ISO 17799: Information Security is an important aspect of healthcare, for example the secure storage and use of patient records being paramount. ISO 17799 is a management system standard, which focuses upon Information Security. • ISO 14000: The environment and how you treat it, as an organization is important in healthcare. ISO 14000 is an Environmental Management System, set out in a similar way to ISO 9001:2000 which can provide a framework to implement effective Environmental Management Systems. BSI can provide registration to this.
  7. 7. CLAUSE 7 – PRODUCT REALIZATION This concerns the process of providing healthcare to the patient. For some segments, such as optometry and dentistry the life cycle can be lifelong, for others it may be much shorter. Some of the aspects that should be considered within healthcare include: • Planning enables the development of processes for serving patients and other customers. Plans may include those for the fitting of implants and prosthetics. • Customer Related Process; in healthcare, it might be that the customer (patient) is unable specify their needs, or respond. The provider may therefore have responsibility for communication. • Design is important. Patients, and therefore their needs are often different. A process is required to determine a generic method of care and/or treatment parameters. • The actual provision of healthcare requires controls. These require the use of best practice and equipment, and competent personnel. Areas of control include patient/health records, patient needs, and admissions. • Related to controls, is the need for identification and traceability. This includes the need for patient records to be maintained, supplies such as implants to be traced, and the correct area of the body for surgery identified. • Any monitoring devices used for control, such as scales, and blood pressure, electrocardiogram, and therapeutic equipment need to be kept accurate. CLAUSE 8 – MEASUREMENT, ANALYSIS & IMPROVEMENT Measurement, analysis and improvement are key aspects for ISO 9001:2000. They also enable a healthcare organization to avoid and learn from mistakes and failings in the process, and focus it upon serving the patient or customer more effectively. Aspects that should be considered include: • The organization should have a plan for all measures, covering for example clinical measurements, and equipment checks. Often measuring is useful for statistical analysis. • The level of patient (customer) satisfaction is a good place to start measuring and analyzing. • As well as measuring the clinical elements of healthcare, there should be other measures, including non-clinical suppliers and services (support processes), and administrative processes taking place. • Non-conformity, which includes the wrong procedure or diagnosis, failing to keep appointments with patients, mistaken identity, and mislabeled drugs, can have severe consequences within healthcare. • Is not necessarily the case that an apparent non-conformance is a failing of the care plan. There is no guarantee of success in healthcare provision; it could be a non-conformance on the part of the patient, which the organization has no control over. • In healthcare, corrective and preventative actions, and continual improvements are vital. Corrective actions should provide a means to stop a non-conformance happening again. Preventative actions should provide a means to stop the non-conformance before it occurs, and continual improvements looks for ways to improve the system. All involve measurement and analysis.
  8. 8. THE BENEFITS OF REGISTERING WITH BSI MANAGEMENT SYSTEMS Choosing BSI means partnering with an organization that has a reputation for excellence and integrity. We are the largest and most respected global management systems registrar, with offices in over 90 countries around the world. Other reasons to choose BSI: • We pride ourselves on the quality of our assessment staff. We have more full time assessors than any other registration body. We also follow some of the strictest criteria when we match assessors with your organization's activities. This ensures they understand the needs and requirements of you industry • BSI is accredited by independent accreditation services, ensuring our integrity. • Use of the highly regarded BSI Registered Logo, and an association with the world’s first and largest national standards body In addition to our management systems registration services, we offer a wide range of complementary services, which add value to our customers, and their management system. These include training courses, product testing, and product certification FREE GUIDANCE DOCUMENTS: • What is ISO 9001:2000 • Glossary of ISO 9000 Terms • 10 Tips of the Selection and Use of a Management System Consultant • 10 Tips for the Transition to ISO 9001:2000 These and more can be downloaded free of charge from: www.bsiamericas.com/getthemost IWA 1: QUALITY MANAGEMENT SYSTEMS – GUIDELINES FOR PROCESS IMPROVEMENTS IN HEALTH SERVICE ORGANIZATIONS Because of the complexity of healthcare, and in order to address issues of quality and safety, ISO (International Organization for Standardization) has published IWA 1. This document which was prepared by the Automotive Industry Action Group, and American Society for Quality (Healthcare Division), with input from a number of other individuals and organizations, is a guidance document to ISO 9004:2000 (“Quality Management Systems – Guidelines for performance improvements”) in healthcare. The document takes the form of ISO 9004:2000, including much of the text from it, however it also includes guidance specifically for healthcare organizations. Throughout the document, there are examples, which relate to healthcare, including those covering; terms and conditions, the control of documents, needs and expectations, planning, training, design, purchasing, and measuring and improving. IWA 1 is a guidance document, which cannot be registered to. IWA 1 can be purchased from www.aiag.org
  9. 9. IMPLEMENTATION AND REGISTRATION PROCESS There are nine steps to implementing ISO 9001:2000 in the healthcare sector: Before you can begin preparing for your application, you will require a copy of the standard. You should read this and make yourself familiar with it. Copies can be purchased from www.bsiamericas.com There are a large number of tools that can be very helpful at every stage of the process of implementing any ISO 9001:2000 based QMS. We recommend “The Route to Registration” published by BSI, and available at www.bsiamericas.com You should begin the entire implementation process by preparing your implementation team. Responsibility for a QMS lies with Senior Management; therefore it is vital that Senior Management is involved from the beginning of the process. There are a wide range of training courses available to assist, at every level of understanding, see www.bsiamericas.com/training. PURCHASE THE STANDARD REVIEW SUPPORT LITERATURE & SOFTWARE ASSEMBLE A TEAM CONSIDER TRAINING REVIEW CONSULTANCY OPTIONS Using a consultant to help you through the process can be very helpful, but consider the cost/benefits. Download BSI’s 10 Tips for the Selection and Use of a Quality Management Systems consultant from www.bsiamericas.com for further help. IMPLEMENT YOUR QMS You don’t just write the documents or develop processes; you’ve got to get staff to use them through training and awareness. CHOOSE A REGISTRAR The registrar is a third-party, like BSI Management Systems, who assesses the effectiveness of your quality management system, and issue a certificate if it meets the requirements of the standard. Factors to consider when choosing a registrar include industry experience, geographic coverage, price and service level offered. GAIN REGISTRATION The key step in the process is a registration assessment, at which your quality management system will be assessed.
  10. 10. REGISTRATION WITH BSI MANAGEMENT SYSTEMS There are seven steps to gaining registration to ISO 9001:2000 with BSI Management Systems CONTINUAL IMPROVEMENT Your registrar will periodically visit you to ensure your system continues to meet the requirements of the standard. The organization will be asked to complete of a company profile. BSI professionals will do everything they can to help you do this. BSI forwards a proposal for delivery of assessment services. Submission of a formal application to BSI Management Systems BSI will appoint a client manager who will be the principal point of contact throughout the registration process, and beyond. Client Managers have knowledge concerning the nature of the client’s business, and will offer support throughout the development of the QMS. INITIAL INQUIRY QUOTATION PROVIDED APPLICATION COMPLETED CLIENT MANAGER APPOINTED PRE-ASSESSMENT (OPTIONAL) BSI can provide pre-assessment services, which review the QMS and establish readiness for the initial assessment. INITIAL ASSESSMENT The formal assessment is entirely objective, checking that the organization does what it says it does, and that it meets the requirements of the standard. The client will be informed of BSI’s recommendation before the assessment team leaves the premises. The initial report is independently reviewed, the formal registration decision taken and if the assessment proved successful, a certificate of registration is issued. Once this has occurred, the organization can advertise its success, and promote registration to ISO 9001:2000. REGISTRATION CONFIRMED
  11. 11. BSI Management Systems - USA 12110 Sunset Hills Road, Suite 140 Reston, VA 20190 USA Tel 1 800 862 4977 703 437 9000 Fax 703 437 9001 BSI Management Systems - Canada 17 Four Seasons Place, Suite 102 Toronto, ON M9B 6E6 Canada Tel 416 620 9991 Fax 416 620 9911 Inquiry@bsiamericas.com www.bsiamericas.com