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Showing posts from February, 2017

Transitioning from ISO 9001:2008 to ISO 9001:2015: Documentation

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Are there any key points to remember in transitioning from ISO 9001:2008 to ISO 9001:2015 especially when it comes to documentation? For the key points to remember in transitioning from ISO 9001:2008 to ISO 9001:2015 refer to the following sections 4.1. In the section 4.1 of Quality Manual, describe activities to monitor, analyze and communicate the information about the internal and external context including three components gathering of information and analysis of the components of internal and external context in QMS processes; communication of information about the context inside the Organization; use of information about the context of the organization.  4.2. In the section 4.2 of Quality Manual, describe activities of interaction of the Organization with the interested parties that include: defining interested parties relevant to the QMS; monitoring and analysis of interested parties’ needs and expectations.  4.3. In the section 4.3 of Quality Manu...

Product updates: ISO 9001:2015 Quality Manual Template

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We have incorporated 12 months’ experience of SO 9001:2015 compliant QMS operation, took into consideration the ISO 9002:2016 requirements and offer the 2nd edition of Quality Manual template . The new Quality manual template is the detailed description of the QMS processes and their interaction. The depth of the description is enough for the Organization to decide that this Quality Manual is the only QMS document , which summarizes all mandatory Procedures as well as the procedures that regulate processes in accordance with the existing good practices. This could be a rational decision of the Organization that provides services for small and mid-size manufacturing companies. ISO 9001:2015 Quality Manual template package includes: Quality Manual Template 1st edition 54 pages MS Word document ( Preview ) Diagrams and models Quality Manual Template 2nd edition 108 pages MS Word document ( Preview ) Diagrams and models Please note that Quality Manuals’ sections are i...

Quality Objectives and Planning to achieve them

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One of the requirements of the new version of ISO 9001 Standard is that there should be a plan to achieve quality objectives. How would/have you come up with a plan for achieving quality objectives and how would/have you document(ed) them? A good and practically proven practice is too word quality objectives of the organization in the form of the Organization’s Annual Development Program, which could have the following structure: # Quality objectives wording Process name Responsible for the implementation Deadlines Resources Report type Quality objectives of the Process (or structural subdivision) are set by the process owner (or structural subdivision manager), based on the analysis of two components: Tasks resulting from Organization’s Development Program for the year; Tasks aimed at the process (or subdivision) development, using own resources. Further details of quality objectives planning are given in the 2nd edition of ISO 9001:2015 Quality Manual .

Numbering System for ISO documentation based on ISO 9001:2015

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As far as I know ISO 9001:2015 do not mandates a specific numbering system for control documents. Is it true that the organization is left open to adopt one that suits it's organizational needs? Also I am interested to know the best practices for the numbering system . Yes, that's right - ISO 9001:2015 does not mandate a specific numbering system for control of documents. Here is an example of the documented information number structure that has been proven in practice: 1. Abbreviation that identifies the document type in accordance with the Documented information structure adopted by the Organization. For example: QSP = Quality System Procedure.  QSF = Quality System Form 2. ISO 9001:2015 clause number the group of documents is relevant to. Example : 7.1 - , a group of documents relevant to resources. 3. Index number of the document in the group. Example : -003 means this is a document #3 in the group. 4. Sometimes it is relevant to give the document...