Note 2 to entry: The management system elements establish the organization s 3. Note 2 to entry: If the scope of the management system 3. Note 2 to entry: Objectives can relate to different disciplines such as financial, health and safety, and environmental goals and can apply at different levels such as strategic, organization-wide, project, product 3.
Note 3 to entry: An objective can be expressed in other ways, e. Note 4 to entry: In the context of quality management systems 3. Note 3 to entry: Risk is often characterized by reference to potential events as defined in ISO Guide , 3. Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event including changes in circumstances and the associated likelihood as defined in ISO Guide , 3.
Note 2 to entry: Documented information can refer to: - the quality management system 3. Note 3 to entry: Processes in an organization 3. Note 4 to entry: A process where the conformity 3. Note 2 to entry: Performance can relate to the management 3. Note 2 to entry: Monitoring is generally a determination 3. Note 2 to entry: Internal audits, sometimes called first-party audits are conducted by, or on behalf of, the organization 3.
In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited. Note 3 to entry: External audits include those generally called second and third-party audits.
Second party audits are conducted by parties having an interest in the organization 3. In French the word 'compliance' is synonymous but deprecated. Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. Note 2 to entry: A correction can be, for example, rework or regrade.
Note 2 to entry: In English this concept is often referred to by other phrases such as business environment, organizational environment or ecosystem of an organization 3. Note to entry: A customer can be internal or external to the organization 3.
Customers outside of the organization are external customers. The output 3. The next process is the internal customer of the preceding process.
Note 1 to entry: A provider can be internal or external to the organization 3. Note 2 to entry: In a contractual situation, a supplier is sometimes called a contractor.
Note 2 to entry: The term management sometimes refers to people, i. When management is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept of management as a set of activities defined above.
For example, management shall is deprecated whereas top management 3. Otherwise different words should be adopted to convey the concept when related to people e. Note 2 to entry: Quality management 3. Note 1 to entry: Objects may be material e. Note 2 to entry: Inherent , as opposed to assigned , means existing in the object 3. Note 2 to entry: The intended use as intended by the customer 3. In a project there can be several design and development stages.
Note 2 to entry: In English the words design and development and the term design and development are sometimes used synonymously and sometimes used to define different stages of the overall design and development. In French the words conception and development and the term conception et development are sometimes used synonymously and sometimes used to define different stages of the overall design and development. Note 2 to entry: Quality objectives are generally specified for relevant functions 3.
Many outputs comprise elements belonging to different generic output categories. Whether the output is then called service, product, software, hardware or processed material depends on the dominant element.
For example, a car consists of hardware e. Note 2 to entry output : The ownership of a product can usually be transferred. This is not necessarily the case for a service.
Processed materials are generally tangible and their amount is a continuous characteristic. Software consists of information and is generally intangible and can be in the form of approaches, transactions or documented information 3.
Note 2 to entry: Objective evidence for the purpose of audit 3. Note 2 to entry: The activities carried out for verification are sometimes called a qualification process 3. Note 2 to entry: The word validated is used to designate the corresponding status. Note 3 to entry: The use conditions for validation can be real or simulated.
Note 2 to entry: Complaints 3. Note 3 to entry: Even when customer 3. Note 2 to entry: Audit findings can lead to the identification of opportunities for improvement 3. Note 3 to entry: In English, if the audit criteria 3. Note 2 to entry: A characteristic can be qualitative or quantitative. Note 3 to entry: There are various classes of characteristic, such as the following: a physical e. Note to entry: Review can also include the determination 3. The organization shall monitor and review the information about these external and internal issues.
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.
The organization shall monitor and review the information about these interested parties and their relevant requirements. When determining this scope, the organization shall consider: a the external and internal issues referred to in 4. Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization. If any requirement s of this International Standard cannot be applied, this shall not affect the organization s ability or responsibility to ensure conformity of products and services.
The scope shall be available and be maintained as documented information stating the: — products and services covered by the quality management system; — justification for any instance where a requirement of this International Standard cannot be applied.
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. NOTE Reference to business in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization s existence; whether the organization is public, private, for profit or not for profit.
Top management shall assign the responsibility and authority for: a ensuring that the quality management system conforms to the requirements of this International Standard; b ensuring that the processes are delivering their intended outputs; c reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management; d ensuring the promotion of customer focus throughout the organization; e ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services. The quality objectives shall: a be consistent with the quality policy, b be measurable; c take into account applicable requirements; d be relevant to conformity of products and services and the enhancement of customer satisfaction; e be monitored; f be communicated; g be updated as appropriate.
The organization shall retain documented information on the quality objectives. The organization shall consider: a the capabilities of, and constraints on, existing internal resources; b what needs to be obtained from external providers.
NOTE Infrastructure can include: a buildings and associated utilities; b equipment including hardware and software; c transportation; d information and communication technology.
NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors such as temperature, humidity, ergonomics and cleanliness. The organization shall ensure that the resources provided: a are suitable for the specific type of monitoring and measurement activities being undertaken; b are maintained to ensure their continued fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources. Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be: — verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards.
Where no such standards exist, the basis used for calibration or verification shall be retained as documented information; — identified in order to determine their calibration status; — safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.
This knowledge shall be maintained, and made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned. NOTE 2 To obtain the knowledge required, the organization can consider: a internal sources e.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: a the size of organization and its type of activities, processes, products and services; b the complexity of processes and their interactions; c the competence of persons.
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled. The output of this planning shall be suitable for the organization's operations. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled in accordance with 8. The organization shall ensure that: a product and service requirements including those considered necessary by the organisation , and applicable statutory and regulatory requirements, are defined; b it has the ability to meet the defined requirements and substantiate the claims for the products and services it offers.
NOTE Requirements can also include those arising from relevant interested parties. This review shall be conducted prior to the organization s commitment to supply products and services to the customer and shall ensure contract or order requirements differing from those previously defined are resolved. Where the customer does not provide a documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance.
Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained. Where requirements for products and services are changed, the organization shall ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements. The organization can therefore choose to consider the requirements of clauses 8.
Inputs shall be adequate for design and development purposes, complete, and unambiguous. Conflicts among inputs shall be resolved. Originally published in , ISO underwent revisions in , , and again in The latest revision was published in September ISO Timeline.
What are the Benefits of ISO ? ISO helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers , management, and employees. Because ISO specifies the requirements for an effective quality management system, organizations find that using the standard helps them:. Achieving ISO certification means that an organization has demonstrated the following:.
In some instances or in some industries, certification is required or legally mandated. Organizations should consider the following as they begin preparing for an ISO quality management system certification:. Training can provide an opportunity to review the ISO standard and apply quality management principles in a practice environment.
Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO based QMS can take ISO training courses , which include courses focused on ISO and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO training relevant.
You can also search articles , case studies , and publications for ISO resources. So, if you are considering starting your implementation project right now, we advise implementation of the new revision.
In comparison to the old version, the ISO revision contains various degrees of change in a number of areas. The new standard addresses new concepts and terminology for Quality Management Systems, such as. It also provides a more strategic approach to the QMS and emphasizes the inclusion of QMS processes in the performance of day-to-day business. The changes introduce risk-based thinking, and are fundamentally different from the previous version.
These processes are now considered to be a vital part of business operations, rather than being added on to normal business practices. You can view all of the changes to the standard by viewing our helpful documents in the right column, especially this infographic. For companies who are adopting the standards for the first time, implementing the revision will prevent you from wasting time implementing standards that are already obsolete, only to transition to new standards later.
In a competitive market, adopting the new standards will allow you to get ahead of some of your competition, and prevent clients from asking when you are going to make the transition to current standards. This may help place you ahead of other businesses who are waiting to make the transition, and show your clients that you are keeping up with current trends.
It is only a matter of time before the new version of ISO will become a requirement on tenders. If your business is already compliant with ISO , then you have a great head start.
Learn about the changes and start planning your transition. Your knowledge will only help save time and money by allowing you to avoid hiring expensive consultants. Learn more about the ISO revision in our special free resources listed here. Also, do not hesitate to contact us and ask any question on this matter.
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