Tag Archives forISO 9001

Statutory vs. Regulatory Requirements

What is the difference between Statutory Requirements and Regulatory Requirements?The term “statutory and regulatory requirements” appear in ISO 9001:2015 for 12 times. These two requirements together are also called as the legal requirements. However, the question here is: “What is the difference between statutory and regulatory requirements?”. The difference between statutory and regulatory requirements is a subtle […]

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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 is an international standard that specifies requirements for quality management systems. The purpose of ISO 9001:2015 is to guide organizations seeking to develop and implement a quality management system. The ISO 9001:2015 standard applies to all types of organizations, including small businesses, medium-sized companies, large corporations, government agencies, and educational institutions. The standard is intended […]

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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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