A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
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The military (e.g. in the U.S. and UK) sometimes uses the term standing (rather than standard) operating procedure because a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" can imply that only one (standard) procedure is to be used across all units.
A military is a heavily-armed, highly organised force primarily intended for warfare, also known collectively as armed forces. It is typically officially authorized and maintained by a sovereign state, with its members identifiable by their distinct military uniform. It may consist of one or more military branches such as an Army, Navy, Air Force and in certain countries, Marines and Coast Guard. The main task of the military is usually defined as defence of the state and its interests against external armed threats.
In clinical research, the International Council for Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs usually get applied in pharmaceutical processing and for related clinical studies. There the focus is always set on repeated application of unchanged processes and procedures and its documentation, hence supporting the segregation of origins, causes and effects. Further application is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities.Study director is mainly responsible for SOPs. The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP. SOPs can also provide employees with a reference to common business practices, activities, or tasks. New employees use a SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard ISO 9001 essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product.
Triage is the process of determining the priority of patients' treatments based on the severity of their condition. This rations patient treatment efficiently when resources are insufficient for all to be treated immediately; influencing the order and priority of emergency treatment, emergency transport, or transport destination for the patient.
Procedures are extensively employed to assist with working safely. They are sometimes called safe work methods statements (SWMS, pronounced as 'Swims'). They are usually preceded by various methods of analyzing tasks or jobs to be performed in a workplace, including an approach called job safety analysis, in which hazards are identified and their control methods described. Procedures must be suited to the literacy levels of the user, and as part of this, the readability of procedures is important.
A procedure is a document that instructs workers on executing one or more activities of a business process. It describes the sequence of steps, and specifies for each step what needs to be done, often including when the procedure should be executed and by whom.
A work method statement, sometimes referred to as a safe work method statement or SWMS or a safe work procedure, is a part of a workplace safety plan. It is primarily used in construction to describe a document that gives specific instructions on how to safely perform a work related task, or operate a piece of plant or equipment. In many countries it is law to have work method statements, or similar, in place to advise employees and contractors on how to perform work related tasks safely.
The term Safe Work Procedure (SWP) originated in Victoria, Australia, and is predominantly used as a risk management tool by industries throughout Australia, particularly in the mining sector. SWPs are also referred to using other terms, such as Standard Operating Procedure (SOPre) (SOP). A Safe Work Procedure is a step by step description of a process when deviation may cause a loss. This risk control document created by teams within the company describes the safest and most efficient way to perform a task. This document stays in the Health & Safety system for regular use as a template or guide when completing that particular task on site.
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.
The ISO 9000 family of quality management systems (QMS) is a set of standards that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
ISO 14000 is a family of standards related to environmental management that exists to help organizations (a) minimize how their operations negatively affect the environment ; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance and an occupational health and safety management system (OHSMS) enables an organization to control its occupational health and safety risks, etc.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
Good clinical practice (GCP) is an international quality standard for conducting clinical trials that in some countries is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. In the European Union, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Directive. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488.
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written—or in some cases electronically recorded—whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
Clinical quality management systems (CQMS) are systems used in the life sciences sector designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The premise of a CQMS is to bring together the activities led by two sectors of clinical research, Clinical Quality and Clinical Operations, to facilitate cross-functional activities to improve efficiencies and transparency and to encourage the use of risk mitigation and risk management practices at the clinical study level.
ISO 31000 is a family of standards relating to risk management codified by the International Organization for Standardization. The purpose of ISO 31000:2018 is to provide principles and generic guidelines on risk management. ISO 31000 seeks to provide a universally recognised paradigm for practitioners and companies employing risk management processes to replace the myriad of existing standards, methodologies and paradigms that differed between industries, subject matters and regions.
ISO/TC 176 is Technical Committee 176 of the International Organization for Standardization (ISO), responsible for Quality management and quality assurance - the ISO 9000 family of standards.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.
The Annex L is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex L is to enhance the consistency and alignment of MSS by providing a unifying and agreed upon high level structure, identical core text and common terms and core definitions. The aim being that all ISO Type A MSS are aligned and the compatibility of these standards is enhanced.
Guidances for statistics in regulatory affairs are applicable to the pharmaceutical industry and medical devices industry. These Guidances represent the current thinking of regulatory agencies on a particular subject. It is to be noted that the term “Guidances” is used in the USA, whereas the term “Guidelines” is used in Europe.