| Term | Definition
| Our comment
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Quality
| To do the right action every time, for once and correct.
| This is a strategic decision to take.
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Quality management system
| Matched activities to direct and control an organization with regard to quality.
| It refers all to activities that are related to the product realization.
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Quality policy
| Overall intention and direction of an organization related to the quality management system as formally expressed and published by the organization's top management | This is where it's all starts. And if, and only if, the management would implement and enforce its policy - then the organization may reach success. Guarantied.
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Quality manual
| A document containing the quality policy, quality objectives, organizational structure diagram, and description of the quality system and its relation to the main processes.
| The purpose of the quality manual is to define the scope of the quality management system in the organization. From it you derive the rest of the quality system. For more specific details turn to this article.
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| Quality procedures | Procedures required by the ISO 9001 Standard in order to ensure that the organization shall perform the minimum requirements of the Standard.
| For more specific details turn to this article. |
Quality objectives
| The goals that the organization is aspire to achieve as a result of the quality management system. | The sheet here is too short. Please review the next article for specific details.
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Quality control
| Part of quality management focused on fulfilling quality requirements.
| The part that is responsible for evaluating periodically every section under the quality management system.
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Quality assurance
| Part of quality management focused on providing confidence that quality requirements would be fulfilled.
| You must validate and verify.
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| Quality planning | Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources in order to fulfill the quality objectives.
| You set the objective according to the measurements and requirements you have within the quality control.
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Combined Quality engineering
| A development process where activities are taken with consideration to other activities (purchase, production, installation etc.) via a multi area team.
| You try to measure the process with quantitative tools. Reports, tables, charts, dashboards - whatever makes you count the process. When it becomes systematic, you create a new process.
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Quality plan
| A document specifying which procedures and related resources should be applied by whom and when to a specific project, product, process or contract.
| One good example is a product portfolio.
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Quality improvement
| Part of quality management focused on increasing the ability to fulfill quality requirements.
| The requirements can be related to any aspect such as effectiveness, efficiency or traceability.
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Process
| A set of interrelated or interacted activities which transforms inputs into outputs.
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Procedure
| A specified documented method to carry out an activity or a process.
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Record
| A document stating results achieved or providing evidence of activities performed.
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Product
| A result of a process.
| Products are divided into four subgroups: hardware, software, a service or a processed material.
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Audit
| An undependable process for evaluating the compatibility of a quality management system to its objectives and to determine the gaps between what was revealed and what is required.
| The audit can be conduct internally (a representative from the organization) and externally (a customer who has interests in the organization or for certifications necessities). Audit can be conducted as a combine audit in which more than one quality management system is being evaluated (for example an audit evaluation quality management systems according to the ISO 9001 and the ISO 14001 requirements). Review solutions for internal audits requirements. |
| Auditor | A person who is competence and trained to carry out an audit.
| The competence to conduct the audit must be defined by the audit client. This person must be undependable to the unit he is auditing.
The audit could be conducted also by a team of auditors.
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| Audit criteria | Set of policies, procedures or requirements used as a reference for conducting the audit.
| Any examination during the audit must be conducted with a reference. |
| Audit programme | A set of examinations, tests or samples, which must be taken in order to maintain a required audit.
| The audit plan may include specific time frames and may be aimed towards a specific purpose.
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| Audit evidence | Records, statements of fact or other information which is relevant to the audit criteria and can be verified.
| Audit evidence could be qualitative (a remark statement according to observation) or quantitative (a numerical evidence).
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| Audit findings | The results of the audit evidence against the audit's criteria
| Audit findings can indicate either conformity or nonconformity with audit criteria, or opportunities for improvement. That what is generating the audit's conclusion.
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Audit conclusion
| Outcome of the audit provided by the audit team 9or auditor), which applies of conformity, nonconformity or an opportunity for improvement.
| Usually the conclusions are documented during the audit and at the end of the audit a summary report is being delivered with all the conclusions.
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| Conformity | Fulfillment of a requirement
| In fact, our daily lives are full of conformities. Otherwise we would be in trouble. A quality management system objective is to retain conformity within the organization throughout the whole time
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| Customer | An organization or a person that receives a product. A customer receives the final product - an output of a process. A customer may be an internal customer as well as external or final.
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| Customer's satisfaction | Customer’s perception of the degree to which the customer’s requirements have been supplied.
| Read more about this subject on this article.
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| Constant Improvement | A recurring activity aimed to increase the ability to fulfill the requirements.
| Even so you are doing well; the organization must detect opportunities self improvement. Plan it first and then perform it. Document it as well.
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| Correction | Action taken to eliminate a detected nonconformity.
| One example for correction is rework over a product. If a control process detected a fault- a correction must be taken. An employee walked by, saw a problem and fixed it - that's a correction. Now, whether you should document it or not? That's a different story. Not every correction must be documented. In this way you are becoming the ISO 9001 clerk. And that is not your goal. |
Corrective action
| Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
| This is the description of the correction taken. The ISO 9001 Standard requires that it would be documented and controlled. An employee walked by, saw a problem and couldn't understand why or couldn't fix it on the spot? This becomes is a different case. Why? Because the corrective action requires you to take care of the root problem – find the cause. It's not enough the deal with the problem itself. You must see that it won't occur again. And document it. And follow it. And close it. Review this article about the corrective action requirements by the ISO 9001 Standard. |
Document
| Information and its supporting medium.
| Documents in the organization may appear in many forms and mediums. To understand more we refer you to this article where we shade some light on the subject.
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| Defect | Non-fulfillment of requirement related to an intended or a specified use.
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| Effectiveness | The extent to which planned activities are realized and planned results achieved.
| This is a key factor for organizations but it is hard to calculate. Especially when the human factor is in the way. But you may try. The results may surprise you. One way is to measure effectiveness is to evaluate the quality objectives. |
| Nonconformity | A non-fulfillment of a requirement where a result was not achieved according to a specific requirement.
| Our daily life is distracted with nonconformities. Then we are in trouble. A quality management system operates a set of requirements in order to prevent nonconformities.
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Preventive action
| Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
| The intention here is to a nonconformity that has not occurred yet. When an employee identifies a potential nonconformity and acts to prevent it before it occurs. The preventive action requires you to take care of the cause of the problem.
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Record
| Document stating results achieved or providing evidence of activities performed.
| Records can be used, for example, to document traceability, to provide evidence of verification, or preventive action and corrective action.
The ISO 9001 Standard requires that some records of the quality management system would be under control. Read this article to learn more.
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Release
| Permission to proceed to next stage of a process.
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Risk
| An index combined of three parameters: a scenario, the probability for the scenario and the level of damage caused by the scenario.
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Risk Assessment
| A documented examination according to a method, of the nature and magnitude of risks.
| In risk assessment you analyze, for every risk the activity, the consequence, the danger, and the classification.
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Risk Management
| The implementation of a strategy of risks control followed by monitoring and evaluation of the processes identified.
| The purpose is to control and reduce risks according to a pre made evaluation that was conducted according to a specified method.
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| Scrape | Disqualifying a product that is not as required or as specified. Scrape activities can be recycling or product demolition.
| It is true for a service as well. Define what is considered to be a scrap and measure it! |
| Statistical Analysis | Analyzing collected data for the purposes of summarizing information. The idea is to Make generalizations about a population based on a sample drawn from that population
| The ISO 9001 Standard requires that you analyze data in order to prove suitability and effectiveness of the quality management system. When you are mass producing (services or products), the most effective way to examine suitability is performing a statistical analysis.
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| Standard | Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics, to ensure that materials, products, process and services are fit for their purpose.
| This is the definition by the ISO organization!!
In our words: a standard is a list of requirements to achieve competence for a certain subject. If you would like to compete you must maintain the requirements.
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Traceability
| To trace the history or location of a product or activity by recorded identification.
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| Validation | Evidences for approval of fulfillment according to objective. The evidences shall indicate that requirements for the product's intended use are fulfilled.
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Re-validation
| A re-approval of validation in case there any changes occurred within the process, a change of equipment, a change in human resources, raw material – anything that may affect the product.
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