Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity.
Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.
This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.
This International Standard relates to ISO and ISO as follows: — ISO Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; — ISO Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.
This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.
Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document including any amendments applies.
ISO , Quality management systems — Fundamentals and vocabulary. The organization shall monitor and review information about these external and internal issues. NOTE 1 Issues can include positive and negative factors or conditions for consideration. NOTE 2 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 3 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 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. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a determine the inputs required and the outputs expected from these processes; b determine the sequence and interaction of these processes; c determine and apply the criteria and methods including monitoring, measurements and related performance indicators needed to ensure the effective operation and control of these processes; d determine the resources needed for these processes and ensure their availability; e assign the responsibilities and authorities for these processes; f address the risks and opportunities as determined in accordance with the requirements of 6.
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a customer and applicable statutory and regulatory requirements are determined, understood and consistently met; b the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c the focus on enhancing customer satisfaction is maintained.
Top management shall establish, implement and maintain a quality policy that: a is appropriate to the purpose and context of the organization and supports its strategic direction; b provides a framework for setting quality objectives; c includes a commitment to satisfy applicable requirements; d includes a commitment to continual improvement of the quality management system. The quality policy shall: a be available and be maintained as documented information; b be communicated, understood and applied within the organization; c be available to relevant interested parties, as appropriate.
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 and on opportunities for improvement see Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. 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 to enhancement of customer satisfaction; e be monitored; f be communicated; g be updated as appropriate.
The organization shall maintain documented information on the quality objectives. The organization shall consider: a the purpose of the changes and their potential consequences; b the integrity of the quality management system; c the availability of resources; d the allocation or reallocation of responsibilities and authorities. The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
The organization shall consider: a the capabilities of, and constraints on, existing internal resources; b what needs to be obtained from external providers. The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. NOTE Infrastructure can include:. The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
NOTE A suitable environment can be a combination of human and physical factors, such as:. The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. 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 continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: a calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; b identified in order to determine their status; c 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 measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be 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 any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. 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:.
When creating and updating documented information, the organization shall ensure appropriate: a identification and description e. 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 be controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations.
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information. 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 see 8.
Communication with customers shall include: a providing information relating to products and services; b handling enquiries, contracts or orders, including changes; c obtaining customer feedback relating to products and services, including customer complaints; d handling or controlling customer property; e establishing specific requirements for contingency actions, when relevant.
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: a the requirements for the products and services are defined, including: 1 any applicable statutory and regulatory requirements; 2 those considered necessary by the organization; b the organization can meet the claims for the products and services it offers.
The organization shall conduct a review before committing to supply products and services to a customer, to include:. The organization shall ensure that contract or order requirements differing from those previously defined are resolved. NOTE In some situations, such as internet sales, a formal review is impractical for each order.
Instead, the review can cover relevant product information, such as catalogues. The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: a functional and performance requirements;. This white paper aims to help you budget effectively, and prevent any unnecessary expenses from occurring.
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This document explains what the process approach is and why it is important, and provides an example of a process flowchart that can be used as a guideline for creating a flowchart for your own company.
This document explains each clause of ISO standard and provides guidelines on what needs to be done to meet each requirement of the standard. It also gives an insight on how to apply process approach and how to plan and analyze processes within organization. White paper. This checklist show exactly which documents are mandatory, and which are optional in the revision of ISO Before now, there were only two ways to become certified in ISO one could either track down dozens of resources and patch them together, or bring in an expert consultant to do all the work.
Presentation MS PowerPoint. Define non conformance type. Define correction. Define root cause analysis. Define proposed corrective action. Define actual corrective action. Define verification taken. Define effectiveness of corrective action. Download Iso Internal audit Define master schedule for each department to conduct internal audit. Define internal audit schedule. Define internal audit report. Non conformance captured here will be reflected in non conformance module where you can take action.
Procedure and forms related to internal audit can be captured in documented information module. Capture the action planned during meeting.
Procedures and forms related to MRM can be captured in documented information module. Download Iso Handboek Gratis Free Documented information Define the department, document type, document name and attach related files. Define retention and disposal mechanism only for forms and checklist type. Able to Raise change request for any document. Define external document by providing details like document name, department, revision number, revision date. Get ISO certified as fast as possible.
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If you find someone selling the Oxebridge kits, please contact us. The kit was released for the purposes of assisting companies who wish to implement ISO without paying for a consultant. Incorporating this kit into your paid consulting contracts violates this purpose, as well as the license agreement restrictions. We reserve the right to pursue legal action against any consulting firm or individual consultant who violates this restriction. Then, the detailed instruction pack provides guidance on how to go in and further customize the documents, layering in your unique processes and approaches to risk-based thinking.
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