Tag Archives forISO 9001

Design Review, Verification and Validation

ISO 9000:2015 Definitions:1. Review:determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.EXAMPLES: Management review, design and development review, review of customer requirements, review of corrective action and peer review.2. Verification:confirmation, through the provision of objective evidence, that specified requirements have been fulfilledThe objective evidence needed for a verification can be […]

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What Is Documented Information In ISO 9001?

Before the release of ISO 9001:2015, there used to be two terms in ISO 9001: Documents and Records.Documents describe what needs to be done, and this includes quality manual, procedures, work instructions etc. Documents get changed or revised with time.Records are evidence of work been done. Records can not be changed (generally) and are retained.In […]

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Full Form of ISO

StandardizationThe history of standardization goes as far back as human history. However, a lot of developments in the field of standardization happened during wars (unfortunately). These developments came in the form of standardization of rail tracks, ammunition, rifles parts etc. In recent human history, globalization has also played a very significant role in promoting standardization. We […]

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Benefits of Implementing ISO 9001 Standard?

Benefits to CompanyImplementing a Quality Management System based on ISO 9001 makes it easier to understand and satisfy customer needs.Better management controls and reporting leading meeting the planned Quality Objectives and better customer satisfactionThe continual improvement requirements of the standard require organizations to improve their products and processesImplementing a process approach leads to fewer problems […]

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ISO 9001 2008 vs ISO 9001 2015

ISO 9001:2015 was released 23 September 2015. Following are the key changes in this standard from ISO 9001:2008: 1. New Structure The new standard has 10 clauses. ISO is in process of harmonizing all management system standards. For this a harmonized structure (Annex SL) has been developed. Some standards such as ISO 30301:2011 (Information and documentation – Management systems […]

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Seven Quality Management Principles

Let’s start with the definition of Quality Management.What is Quality Management?ISO 9000:2015 defines Quality Management as “management with regard to quality”. This includes establishing quality policies, quality objectives, and processes to achieve these quality objectives. This then leads us to the next definition, that is the definition of “Quality Management System.”What is Quality Management System (QMS)?ISO […]

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10 Top Level Clauses ISO 9001:2015

ISO 9001:2015 – 10 Top Level Clauses1. ScopeWhen/why should an organization adopt this standard? 2. Normative referencesUse ISO 9000 for terms and definitions3. Terms and definitionsDefinitions of various terms referred in the standard.4. Context of the organizationDetermine the purpose and the direction of the organization.5. LeadershipCommitment of the top management, quality policy, roles and responsibilities.6. […]

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How many mandatory documents does ISO 9001-2015 require?

Did you know that recently release ISO 9001:2015 requires you to maintain five documented information (procedures) and retain 22 documented information (records)? Have a look at these.Mandatory DocumentsScope of the Quality Management System (4.3) Scope of the QMS including the products and services covered and the justification of the requirements that can not be applied. Operation of […]

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