March, 2017 Newsletter Articles

ISO 9001:2015, Clause 4

Mar 4, 2017 in Newsletter | Comments Off on ISO 9001:2015, Clause 4

This article summarizes the ISO 9001:2015 requirements in Clause 4, Context of the Organization, and identifies the changes from ISO 9001:2008. 4. Context of the Organization 4.1 Understanding the Organization and its Context 4.2 Understanding the Needs and Expectations of Interested Parties 4.3 Determining the Scope of the Quality Management System 4.4 Quality Management System and its Processes 4.1 Understanding the Organization and its Context Determine the external and internal issues that: are relevant to the organization’s purpose...

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Role of a Process Owner

Mar 4, 2017 in Newsletter | Comments Off on Role of a Process Owner

Processes need to be established, implemented, maintained, and improved for an organization to consistently deliver products and services that satisfy its customers. To ensure this happens, each process should have a named owner. What is a process? It is a set of interrelated or interacting activities that use inputs to deliver an intended result, for example, an output, product, or service. The inputs to a process are the outputs from other processes, and the outputs of a process are inputs to other processes. Processes are planned and...

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Interested Parties

Mar 4, 2017 in Newsletter | Comments Off on Interested Parties

An “interested party”, according to ISO 9000:2015, 3.2.3, is a person or organization that can affect, be affected by, or perceive itself to be affected by, a decision or activity. ISO 9001:2015, 4.2, states that an organization must determine the interested parties that are relevant to its quality management system, along with the relevant requirements of those interested parties. The reason for doing this is that an interested party may affect an organization’s ability to consistently provide products and services that meet...

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External and Internal Issues

Mar 4, 2017 in Newsletter | Comments Off on External and Internal Issues

ISO 9001:2015, 4.1, Understanding the organization and its context, states that an organization must determine the internal and external issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended quality results. It also requires the organization to monitor and review information about these external and internal issues. Note 1 in the standard says that issues can include positive and negative factors or conditions for consideration.   Note 2 states that understanding the external...

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Examples of External Issues

Mar 4, 2017 in Newsletter | Comments Off on Examples of External Issues

According to ISO 9001:2015, 4.1, Note 2, external issues arise from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international). Examples of external issues are: Supply chain disruption Loss of a key supplier Technology shifts Competitive pressures Money exchange rates Oil price changes Increased regulations Patent expirations Trade union regulations Ventures into new markets Changes in financial markets Tightening of lending from banks Funding for non-profits Scarcity...

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Examples of Internal Issues

Mar 4, 2017 in Newsletter | Comments Off on Examples of Internal Issues

According to ISO 9001:2015, 4.1, Note 3, internal issues are related to values, culture, knowledge, and performance. Examples are: Structure of organization Implementation or transition to ISO 9001:2015 Expected retirement of key personnel Availability of reliable, qualified workforce Capacity for product production; service delivery Addition of a second shift for increased sales Aging machinery or obsolete equipment Aging workforce and new hires Formation of a labor union Relocation of the company Business performance Poor customer...

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Gap Checklists

Mar 4, 2017 in Newsletter | Comments Off on Gap Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

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