Accreditation to the ISO 15189:2012 Standard is fast gaining currency with clinical laboratories. “Assuring quality and competence” is designed to help every laboratory understand this Standard.
Most of the contributors to this book have been NABL assessors. They have observed that many well qualified and experienced Laboratory Directors find it difficult to comprehend the requirements. Based on their experience, the authors have provided several examples of nonconformities that make it easier to understand the intent of the clause.
The editors, Swaroop K Sood, Rajat Mukherjee, and Suneet Sood, intend that this book helps laboratories find a smoother path to accreditation. It is also their hope that laboratories already accredited will use it to understand the clauses better, and in their pursuit of continual improvement. Realizing that their own understanding of the Standard has improved as they wrote this book, they believe that assessors of accreditation boards too will find it useful.
This book explains Clauses 4 and 5 of the Standard, which lists the management requirements in Clauses 4.1 through 4.15 and the technical requirements in Clauses 5.1 through 5.10. Each of these clauses is discussed in a separate chapter, clause by clause, sub-clause by sub-clause. Thus, the chapters in this book are titled “4.1 Organizational and management responsibility” through ‘5.10 Laboratory Information Management”. In addition, the book provides illustrative master lists of documents and of records, and a sample Laboratory Biosafety Manual. There are over 90 references, and several tables and boxes to help explain the clauses.
Each chapter is written in two parts.
Part I is an explanation of the clause. It discusses the ‘Intent’ of the requirement and, where required, the associated science. The editors have often provided examples of non-fulfilment of the requirements by the laboratories in boxes. Where necessary, the corrective and preventive actions (CAPA) taken to deal with these nonconformities (NCs) are provided. As mentioned above, if there is an ordered list under any sub-clause, the corresponding sub-clause in this book has a matching ordered list.
Part II of every chapter is an illustrative Quality Manual. Every laboratory is required to maintain a Quality Manual, which assessors will examine during the accreditation process. Part II is further divided into two sections, A (Policies) and B (Processes and Procedures). The Policies represent a mission statement by the laboratory, and this statement guides the Processes and Procedures. The Processes and Procedures represent a detailed explanation of the steps taken by the laboratory to fulfil the requirements of the Standard, in accordance with its policies.
The editors have no objection if any laboratory uses portions of part II as a template for its Quality Manual. Obviously, if the Processes and Procedures section makes a claim, the laboratory must be able to confirm it to the assessors.
At the end of the book the editors have provided an example of a procedure manual—the Laboratory Biosafety Manual of the KBG Hospital Laboratory.
The primary purpose of this book is to help a laboratory understand and implement the clauses of the ISO 15189 Standard. Explaining the science behind the clauses is a secondary objective, and the authors have often limited the explanations in the interests of conciseness and understanding. Nevertheless, readers will often wish to learn more. Detailed explanations for several topics are available from the references added to the text, and on the webpage www.medlabwisdom.org. The editors plan to keep adding to the webpage, and are hoping for some comments on the site.
Most of the contributors to this book have been NABL assessors. They have observed that many well qualified and experienced Laboratory Directors find it difficult to comprehend the requirements. Based on their experience, the authors have provided several examples of nonconformities that make it easier to understand the intent of the clause.
The editors, Swaroop K Sood, Rajat Mukherjee, and Suneet Sood, intend that this book helps laboratories find a smoother path to accreditation. It is also their hope that laboratories already accredited will use it to understand the clauses better, and in their pursuit of continual improvement. Realizing that their own understanding of the Standard has improved as they wrote this book, they believe that assessors of accreditation boards too will find it useful.
This book explains Clauses 4 and 5 of the Standard, which lists the management requirements in Clauses 4.1 through 4.15 and the technical requirements in Clauses 5.1 through 5.10. Each of these clauses is discussed in a separate chapter, clause by clause, sub-clause by sub-clause. Thus, the chapters in this book are titled “4.1 Organizational and management responsibility” through ‘5.10 Laboratory Information Management”. In addition, the book provides illustrative master lists of documents and of records, and a sample Laboratory Biosafety Manual. There are over 90 references, and several tables and boxes to help explain the clauses.
Each chapter is written in two parts.
Part I is an explanation of the clause. It discusses the ‘Intent’ of the requirement and, where required, the associated science. The editors have often provided examples of non-fulfilment of the requirements by the laboratories in boxes. Where necessary, the corrective and preventive actions (CAPA) taken to deal with these nonconformities (NCs) are provided. As mentioned above, if there is an ordered list under any sub-clause, the corresponding sub-clause in this book has a matching ordered list.
Part II of every chapter is an illustrative Quality Manual. Every laboratory is required to maintain a Quality Manual, which assessors will examine during the accreditation process. Part II is further divided into two sections, A (Policies) and B (Processes and Procedures). The Policies represent a mission statement by the laboratory, and this statement guides the Processes and Procedures. The Processes and Procedures represent a detailed explanation of the steps taken by the laboratory to fulfil the requirements of the Standard, in accordance with its policies.
The editors have no objection if any laboratory uses portions of part II as a template for its Quality Manual. Obviously, if the Processes and Procedures section makes a claim, the laboratory must be able to confirm it to the assessors.
At the end of the book the editors have provided an example of a procedure manual—the Laboratory Biosafety Manual of the KBG Hospital Laboratory.
The primary purpose of this book is to help a laboratory understand and implement the clauses of the ISO 15189 Standard. Explaining the science behind the clauses is a secondary objective, and the authors have often limited the explanations in the interests of conciseness and understanding. Nevertheless, readers will often wish to learn more. Detailed explanations for several topics are available from the references added to the text, and on the webpage www.medlabwisdom.org. The editors plan to keep adding to the webpage, and are hoping for some comments on the site.
