View ISO9001 QMS
Procedures Manual Sections
- Introduction to ISO
- Manual Preparation
- QMS Quality Manual
- QMS Quality Procedures
- EMS Quality Procedures
- Reports and Forms
Weight: 5 pounds
ISO Definitions
- Accreditation
- The act whereby a nationally recognized body approves an organization to operate an audit and registration program.
- Accreditation Bodies
- Member countries have organizations that are chartered to accredit Registrars. In the US, it's the Registrar Accreditation Board (RAB); in Canada, the Standards Council of Canada (SCC), and in the Netherlands, the Raad Voor Accreditatie (RvA).
- These ISO Accreditation Bodies publish the requirements that they set forth for Registrars to become accredited. These requirements generally follow other ISO documents. The Accreditation bodies regularly audit registrars' procedures, systems and audit practices to ensure they meet and maintain systems to the requirements.
- American Society for Quality
- (ASQ) established the Registrar Accreditation Board (RAB) in 1989. In 1991, ANSI and RAB joined forces to establish the American National Accreditation Program (NAP) for Registrars of Quality Systems. On January 1, 2005, RAB and the ANSI-RAB NAP was replaced by the ANSI-ASQ National Accreditation Board (ANAB).
- Audit Standard
- An authentic description of essential characteristics of audits, which reflects current thought and practice.
- Auditee
- The organization being audited.
- Auditors
- Auditors work for or contract to Registrars to perform registration assessments and surveillances. They are the "front line" in the process. Registrars are responsible for ensuring Auditors meet qualification requirements. Their requirements include training in auditing, ISO 9001 training, and at least one member of the audit team must have experience in the industrial sector of the company being audited.
- Auditors collect the objective evidence demonstrating the effectiveness (or lack thereof) of the company's quality management system and make registration recommendations to the Registrar. The Registrar has the ultimate decision however.
- ANSI
- The American National Standards Institute or ANSI is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system.
- Auditing Organization
- A unit or function that carries out audits through its employees. This organization may be a department of the auditee, client or an independent third party. (See Auditors).
- Capability
- Ability to perform designated activities and to achieve results, which fulfill specified requirements.
- Certification
- The authoritative act of documenting compliance with agreed requirements.
- Certification Body
- An impartial organization possessing the necessary competence to operate a certification program.
- Characteristic
- A physical, chemical, visual functional or any other identifiable property of a product or part or material.
- Client
- The person or organization requesting the audit. Depending on circumstances, the client may be the auditing organization, the auditee or a third party.
- Company
- Term used primarily to refer to a business first party, the purpose of which is to supply a product or service.
- Compliance
- A judgment that a product or service meets the requirements of a specific standard.
- Conformity
- The fulfillment of specified requirements. Same as compliance.
- Contract Review
- The systematic activities carried out before signing the contract, to ensure that requirements for quality are adequately defined, free of ambiguity, documented and realizable by the supplier.
- Contractor
- The supplier.
- Corrective Action
- An action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation, to prevent recurrence. The distinction between correction such as repair, rework or adjustment and corrective action is that the former relates to the disposition of an existing nonconformity, whereas, corrective action relates to the elimination of its causes.
- Criticality
- A relative measure of the consequences of a failure mode and its frequency of occurrence.
- Customer
- Ultimate consumer, user, client, beneficiary or second party.
- Defect
- The non-fulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements.
- Degree of Demonstration
- The extent to which evidence is produced to provide confidence that specified requirements are fulfilled.
- Dependability
- The collective term used to describe the availability of performance and its influencing factors: reliability, performance, maintainability performance and maintenance support performance. Dependability is used only for general descriptions in non-quantitative terms and is a time-related aspect of quality.
- Design Review
- A formal, documented, comprehensive and systematic examination of a design to evaluate the design requirements and the capability of the design to meet the requirement for quality and to identify problems and propose solutions. A design review can be conducted at any stage of the design process.
- Design Specifications
- A description of the physical and functional requirements for a product. In its initial form, the design specification is a statement of functional requirements with only general coverage of physical and test requirements. The design specification evolves through the research & development phase to reflect progressive refinements in performance, design, configuration and test requirements.
- Design Transfer
- The transfer of the design basis or baseline into specifications for the product, its components, packaging, labeling, and the manufacturing and quality assurance procedures, methods, specifications, etc., so that the product can be produced using production methods.
- Discrepancy
- A failure to meet the specified requirement, supported by evidence (Also can be called Nonconformance, Deficiency or Finding).
- Disposition of Non-conformity
- The action to be taken to deal with an existing nonconforming condition in order to resolve the nonconformity.
- Document
- Something written or printed that provides factual information or proof; any object used as evidence; to prove or support by means of documents.
- Environment
- The conditions, circumstances, influences and stresses surrounding and affecting the product during manufacturing, storage, handling, transportation, installation and use.
- Failure
- An event in which a previously acceptable product does not perform one or more of its required functions within the specified limits under specified conditions.
- Failure Analysis
- The logical, systematic examination of an item, including its diagrams or formulas, to identify and analyze the probability, causes and consequences of potential and real failures.
- Failure Cause
- The physical or chemical process, design defect, quality defect, component misapplication, or other processes which are the basic reason for failure or which initiate the physical process by which deterioration proceeds to failure.
- Failure Effect
- The consequences a failure has on the operation, function, or status of a product.
- Failure Mode
- The manner in which a failure is observed. The way a failure occurs and its impact on the product performance.
- Failure Mode and Effect Analysis
- The process of identifying potential design weaknesses through reviewing schematics, engineering drawings, etc., to identify basic faults at the part/material level and determine their effect at finished or sub - assembly level on safety and effectiveness.
- Failure Pattern
- The occurrence of two or more failures of the same component or feature in identical or equivalent application, which are caused by the same basic failure mechanism.
- Fault Tree Analysis
- The process of identifying potential design weaknesses using a highly detailed logic diagram depicting basic faults and events that can lead to system failure and/or safety hazard.
- ISO
- The International Organization for Standardization or just ISO
- ISO Member Body
- Countries that have joined the ISO initiative and have organizations that are chartered to accredit Registrars in their country.
- Lead Auditor
- The individual appointed by the registration organization to be responsible for the quality audit.
- Management Review
- A formal quality evaluation, by top management, of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.
- National Accreditation Program
- In 1991, ANSI and RAB joined forces to establish the American National Accreditation Program (NAP) for Registrars of Quality Systems. On January 1, 2005, RAB and the ANSI-RAB NAP was replaced by the ANSI-ASQ National Accreditation Board (ANAB).
- Non-conformance
- A condition of any product or component in which one or more characteristics do not conform to requirements. Includes failures, deficiencies, defects and malfunctions.
- NIST
- The National Institute of Standards and Technology is a non-regulatory federal agency within the U.S. Commerce Department's Technology Administration. NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.
- Organization
- A company, corporation, firm, enterprise or institution, or part thereof (whether incorporated or not, public or private) that has its own function(s) and administration that supplies products or services to other organizations. See supplier.
- Organizational Structure
- The set of formal and informal responsibilities, authorities and relationships, arranged in a pattern, through which an organization performs its functions.
- Plan-Do-Check-Act
- The process-based improvement cycle used in both ISO 14000 and ISO 9000 standards.
- Policy
- A definite course or method of action to guide and determine present and future decisions. It is a guide to decision making under a given set of circumstances within the framework of corporate objectives, goals and management philosophies.
- Preventive Action
- An action taken to eliminate the causes of a potential nonconformity, defect or other undesirable situation, to prevent occurrence.
- Procedure
- A particular way of accomplishing something, an established way of doing things, a series of steps followed in a definite regular order. It ensures the consistent and repetitive approach to actions. Quality Procedures are procedures that meet or exceed ISO9000 requirements.
- Process
- A set of interrelated resources and activities that transform inputs into outputs with the aim of adding value. Resources include personnel, facilities, equipment, technology, methodology and finances. The aim of adding value if quality related.
- Product
- The result of activities or processes. A product can be tangible or intangible, or a combination of both.
- Product Liability
- A generic term used to describe the responsibility on a producer or others to make restitution for loss related to personal injury, property damage or other harm caused by a product or service. Liability is defined by law so that it may vary from country to country according to national legislation.
- Production Permit
- A written authorization for a product, before its production, to depart from originally specified requirements; also known as deviation.
- Purchaser
- The customer.
- Qualification
- A documented determination that a product (and its associated software), component, packaging or labeling, meets all prescribed design and performance requirements.
- Quality
- The composite of all the characteristics, including performance, of an item, product or service that bear on its ability to satisfy stated or implied needs. In a contractual environment, needs are specified, whereas, in other environments, implied needs should be identified and defined. In many instances, needs can change with time; this implies periodic revision of requirements for quality. Needs are usually translated into characteristics with specified criteria. Quality is sometimes referred to as "fitness for use", "customer satisfaction", or "conformance to the requirements."
- Quality Assurance
- A planned and systematic pattern of all actions necessary to provide adequate confidence that the product, its components, packaging and labeling are acceptable for their intended use.
- Quality Audit
- A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
- The quality audit typically applies, but is not limited to a quality system or elements thereof, to processes, to products, or to services. Such audits are often called a "quality system audit", "process quality audit", "product quality audit" or "service quality audit."
- Quality audits are carried out by staff not having direct responsibility in the areas being audited but preferably, working in cooperation with the relevant personnel.
- One purpose of a quality audit is to evaluate the need of improvement or corrective action. An audit should not be confused with surveillance or inspection activities performed for the purpose of process control or product acceptance.
- Quality audits can be conducted for internal or external purposes.
- Quality Audit Observation
- A statement of fact made during quality audit and substantiated by objective evidence.
- Quality Auditor
- A person who has the qualification status to perform quality audits.
- Quality Control
- The operational techniques and activities that are used to fulfill requirements for quality. All that is done to be sure that the product is what it should be.
- Quality control involves operational techniques and activities aimed both at monitoring a process and at eliminating causes of unsatisfactory performance at all stages of the organization's operation in order to result in economic effectiveness.
- Quality Document
- A document that contains requirements for quality system elements for products or services. The results of activities such as inspections or quality audits.
- Quality Evaluation
- A systematic examination of the extent to which an entity (part, product, service or organization) is capable of meeting specified requirements. A quality evaluation may be used to determine supplier quality capability. In this case, the result of quality evaluation may be used for qualification, approval, and registration or accreditation purposes.
- A quality evaluation examines potential quality capability, whereas, a quality audit additionally examines effective implementation.
- Quality Improvement
- The actions taken to increase the value to the customer by improving the effectiveness and efficiency of processes and activities throughout the organizational structure.
- Quality Losses
- The losses caused by not realizing the optimum potential of resources in processes and activities. Some examples of quality losses are the loss of customer satisfaction, loss of opportunity to add customer value, loss to the organization or society, as well as waste of resources and materials.
- Quality Management
- All activities of the overall management function that determine the quality policy, objectives and responsibilities, and implements them by means such as quality planning, quality control, quality assurance and quality improvement. The responsibility for quality management belongs to all levels of management but must be driven by top management. Its implementation involves all members of the organization.
- Quality Management Principles
- Used by management as a guide towards improving performance. The Quality Management Principles were derived from the experience of experts on the technical committees and represent the main elements that a good quality system must have.
- The eight principles are: Customer Focus, Leadership, Involvement of People, Process Approach, Systems Approach to Management, Continual Improvement, Factual Approach to Decision-making, and Mutually Beneficial Supplier Relationship.
- Quality Manual
- A document stating the Quality Policies and Objectives. and describing the quality system of an organization. The Quality Manual may relate to the totality of an organization's activities or only to a part of it.
- A quality manual will normally contain, or refer to, the quality policy, the responsibilities, authorities and inter - relationships of personnel who manage, perform, verify or review work affecting quality, the quality system procedures and instruction, a statement for reviewing, updating and controlling the manual.
- A quality manual can vary in depth and format to suit the needs of an organization. It may be comprised of more than one document in some instances. When its only purpose is for demonstration, it may be called a quality assurance manual.
- Quality Plan
- A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, project or contract. A quality plan pertaining to a specific application usually references the quality manual.
- Quality Policy
- The overall Quality Objectives. intentions and direction of an organization regarding quality, as formally expressed by top management.
- Quality Requirements
- A translation of customer needs into a set of quantitatively or qualitatively stated requirements for the characteristics of a product or service to enable its realization and examination. The requirements for quality should be initially expressed in functional terms and documented.
- Quality System
- The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. The quality system should only be as comprehensive as needed to meet the quality objectives. The quality system of an organization is designed primarily to satisfy the internal requirements of the organization and is not limited to the quality assurance requirements of a particular customer. For contractual or mandatory quality assessment purposes, demonstration of the implementation of identified elements of the quality system may be required.
- RAB
- Registrar Accreditation Board. The U.S. organization for accreditation of Environmental Management Systems ISO 14001, Quality Management Systems ISO 9000 registrars, and auditor training course providers. On January 1, 2005, RAB and the ANSI-RAB NAP was replaced by the ANSI-ASQ National Accreditation Board (ANAB).
- Record
- A document that furnishes objective evidence of activities performed or of results achieved. A quality record provides objective evidence of the extent of the fulfillment of the requirement for quality or the effectiveness of the operation of a quality system element. Some of the purposes of quality records are demonstration, traceability and corrective actions. A record can be written or stored on any data medium.
- Registrar
- Organizations that issue ISO certification. Also called "certification bodies" or "registration bodies".
- Their place in the system is to verify companies meet the requirements of ISO 9001:2000 and certify or register companies that do. Registrars must meet the requirements of the Accreditation Bodies. These requirements include things such as independence; Registrars cannot consult for instance. This system ensures uniformity in the registration process.
- Registration
- A formal verification process by an accredited body that an organization has been audited and shown to comply with ISO 9000.
- Reliability
- The characteristic of a product, or any component thereof, expressed as a probability that it would perform its required functions under defined conditions for specified operating periods.
- Reliability Assessment
- A quantitative assessment of the reliability of a product, system or portion thereof. Such assessments usually employ mathematical modeling, directly applicable results of tests on the product, failure data, estimated reliability figures, and non-statistical engineering estimates.
- RvA
- The Dutch council for accreditation. It was established to supervise and monitor organizations which judge quality systems and/or examine an organization on the basis of European and international standards and provide accreditation.
- SCC
- The (Standards Council of Canada) an ISO Member body that is chartered to accredit Registrars in Canada.
- Self-Inspection
- Inspection of the work performed, by the performer of that work, according to specified rules. Self-inspection is used for process control by the operator.
- Service
- The results generated by activities at the interface between the supplier and the customer and by supplier internal activities, to meet the customer requirements. Delivery or use of tangible products may form part of the service. A service may be linked with the manufacture and supply of tangible products.
- Severity
- The consequences of a failure mode. Severity considers the worst potential consequences of a failure, determined by the degree of injury.
- Specification
- Documented detailed requirements with which a product or service has to comply.
- Supplier
- The organization that provides a product or service. Same as subcontractor.
- System
- The principal functioning entities comprising the product, e.g. hardware, software. Also an organized and disciplined approach to accomplish a task, e.g., a failure reporting system.
- Testing
- The determination by technical or scientific means of the properties or elements of a product or its components, including functional operation, and involving the application of established scientific principles and procedures.
- Traceability
- The ability to trace the history, application or location of a product and, in some cases, service by means of recorded identifications. Traceability may refer to: a product, a calibration and its relationship to the measuring equipment and the national or international standards, primary standards, basic physical constants, properties or references materials. Traceability requirements should be specified for some stated period of history or to some point of origin.
- Validated
- The state of being confirmed by examination and provision of objective evidence that the particular requirements for a specific intended use have been met. Validation is normally performed on the final product under defined operating conditions, and when necessary, performed in earlier production stages. Multiple validations may be carried out if there are different intended uses.
- Verification
- Confirmation by examination and provision of objective evidence that specified requirements have been met. In design and development, verification concerns the process of examining the results of a given activity to determine conformity with the input requirement for that activity.
- Waiver
- A written authorization to release a product, which does not conform to the specified requirement. Also called concession.
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