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ISO 9001 - Clause 7 - Support - Resources, Competence, Awareness, Communication.

  Clause 7 of ISO 9001:2015 pertains to support. It requires organizations to determine and provide the necessary resources to establish, implement, maintain, and continually improve the Quality Management System. This includes provisions for personnel, infrastructure, work environment, monitoring and measuring resources, and organizational knowledge. 7.1 Resources This clause requires businesses to determine and provide all necessary resources for the Quality Management System's establishment, execution, maintenance, and continual improvement. Examples of resources are, 1. Infrastructure 2. Human Resource 3. Machinery and Equipment's 4. Financial support etc.  These resources are essential to ensuring the organization can meet its objectives and deliver quality products or services. Template - Maintenance Plan for Month Template - Maintenance Plan for Year 7.2 Competence This sub-clause focuses on ensuring that the personnel executing the processes are competent. This could b...

ISO 9001 - Clause 6 - Planning - Risk and opportunity, Quality Objectives and Planning of change

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  There are 3 sub clause. Clause 6.1, Clause 6.2 and Clause 6.3.  6.1 - Risk and opportunity  Organizations shall plan actions that address potential risks and opportunities, integrate them into their quality management system processes, and evaluate the effectiveness of these actions. It emphasizes a risk-based approach to enhance the system's ability to achieve its intended results, prevent undesirable effects, and achieve continual improvement. When identifying Risk and opportunity organization shall also consider internal and external issues.  Template - Risk and op portunity  6.2 - Quality Objectives Organizations shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system. These objectives must be SMART S - Specific  M - Measurable  A - Achievable R - Relevant  T - Time Bound Quality objectives should be communicated, updated as appropriate, and consistent with the quality pol...

ISO 9001 - Clause 5: Leadership

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  Clause 5 has three sub clause 5.1, 5.2 and 5.3. which specifies required related to leadership role and responsibilities, requirement of Quality Policy and roles and responsibilities for implementation of QMS. Clause 5.1 - Leadership  This clause is mainly for top management of organisation. It includes role/ function of top management which includes as below, Integrating QMS with business requirements Promoting risk based approach Accountable for effectiveness of QMS Establishing Quality Policy and Quality objectives Providing resource needed (e.g. Human resource, Infrastructure, Equipment's, etc.) Promoting improvements Engaging, directing and supporting team for effective implementation Communicating importance of QMS Clause 5.2 - Quality Policy A policy is a top-level document that provides a broader framework for organizations. It's a commitment of the organization. Key requirements for a quality policy include: Alignment with the organization's context (for example,...

ISO 9001 - Clause 4: Context of the Organization, Scope of QMS, and Interested Parties

  ISO 9001 Clause  4, which deals with the 1) Context of the organization, 2) Needs and Expectation of interested parties 3)  Scope of the quality management system 4) Quality management system and process.  Clause 4.1 - Understanding organization and its context The intent of this clause is to understand the organization's internal and external issues. Internal issues are where the organization has control over its issues. They are related to the values, culture, knowledge, and performance of the organization. External issues are where the organization does not have control over external issues. These issues can be positive or negative. These issues can arise from legal, technological, competitive, market, cultural, social, economic environments, and can come from local, regional, national, or international sources. You can use below form for capture Internal and External Issues  As Per ISO 9001:2015 Amendment 2024 Organization shall review whether climate chan...

ISO 9001 - Clause 1 to 3: Scope, Normative References, Terms and Definitions

  Clause 1 - Scope You can edit text on your website by double clicking on a text box on your website. Alternatively, when you select a text box a settings menu will appear. your website by double clicking on a text box on your website. Alternatively, when you select a text box Clause 2 - Normative References Clause 2 of ISO 9001:2015 refers to normative references. It indicates that there are no normative references in the standard that are indispensable for its application. Clause 3 - Terms and Definitions Clause 3 of ISO 9001:2015 provides terms and definitions relevant to the quality management system, ensuring that all users of the standard have a common understanding of the terminology used.

Context is Key: How Understanding Internal and External Issues can Impact Your Organization's Success

 As a business owner or manager, it's crucial to understand the internal and external factors that can affect your organization's success. By gaining a deeper understanding of the context in which your business operates, you can make informed decisions and take proactive measures to address potential challenges. Section 1: Understanding the Organization and its Context Understanding the organization and its context is crucial for any business to succeed. External and internal issues both play a significant role in shaping the context in which a business operates. External issues refer to factors outside of the organization's control, such as legal, technological, competitive, market, cultural, social, and economic environments. For example, a business operating in a highly competitive market may struggle to differentiate itself from other similar businesses. A business operating in an area prone to natural disasters may face challenges in terms of maintaining continuity of ...

Histogram

  What is histogram  Histogram bar graph showing the distribution of the various measurements made on a component or process. Because the height of the bar represents how frequently each particular value occurs, these are also known as frequency distributions. A histogram is a graphical representation of data that shows the frequency or number of observations within a given range of values called as bins. It is a bar chart with the x-axis representing the range of values and the y-axis representing the frequency of observations. Histograms are used to visualize the distribution of a dataset and to identify patterns and trends. They are useful for understanding the characteristics of a dataset, such as the center, spread, and shape of the distribution. To create a histogram, you first need to decide on the bin size, which is the range of values represented by each bar on the chart. You then count the number of observations that fall within each bin and plot the data on the char...