ISO 9001 2015 course in Pakistan

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  • Added: September 4, 2020

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  • Location: Pakistan

  • State: Taxila

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ISO 9001 2015 course in Pakistan The fact that the language of PDCA and risk-based thinking is entwined throughout the standard, combined with ISOs approach of providing standards without prescriptively telling organizations how to operate, means that it can be difficult for organizations to create a detailed roadmap to ISO 9001:2015 certification. In fact, there are multiple paths to certification depending on the type of organization and its priorities. Table 6 shows one possible approach to mapping the elements of PDCA, risk-based thinking, and leadership involvement to the high-level structure prescribed by Annex SL, as well as some of the complementary ISO standards that can assist with each stage of the implementation as defined in Annex B of ISO 9001:2015 This approach to aligning the structure with the basic elements of PDCA, risk-based thinking, leadership involvement, and complementary standards can help organizations understand the details of the standard and how to apply them to their own priorities. A more detailed map could highlight all those places in which elements overlap and complement one another in the same section, which would provide a more nuanced and sophisticated approach that might benefit more complex organizations.

Previous iterations of ISO 9001 have received criticism for placing an excessive burden for documentation on organizations.xiv To meet this criticism, ISO 9001:2015 does not prescribe specific approaches to the governance of documentation. It is up to each organization to determine its approach to maintenance, retention, and disposition of all documentation.

ISO 9001:2008 adhered to the guidelines for QMS documentation outlined in ISO/TR 10013:2001, which distinguished between records, processes, and Quality manuals in a much more defined way.xv ISO 9001:2015 has simplified these categories to one overarching category of “documented information.” ISO 9001:2015 uses the phrase “maintain documented information” to suggest working documentation that requires updating, such as procedures and work instructions, and uses “retain documented information” to suggest records, which are completed and archived documents that provide evidence of past conformity with requirements. While ISO 9001:2015 does not explicitly state categories of documentation such as procedures, work instructions, Quality manuals, and records, organizations should still look to the definitions and categories provided in ISO/TR 10013 for guidance on what the options for documentation should be. It is, however, the responsibility of the organization to determine the best media or type for its documentation. Organizations can also look for guidance on documentation from their technical writers and business analysts. Where the term “information” is not preceded by “documentation,” ISO 9001:2015 does not require that the information be documented.

This less prescriptive approach allows organizations to determine their own scope for documentation and to scale the requirements to their resources. It is important to note, however, that the lack of prescriptive direction is not the same as reduced responsibilities for documentation. Section 7.5 lays out the general responsibilities for documentation that ensures the effectiveness of the QMS.xvi Organizations must ensure that all documentation has adequate identifying information, is in a media format that facilitates easy and efficient interaction, and that it is regularly reviewed and approved by appropriate subject matter experts. Organizations must also ensure that documentation is subject to governance that addresses control, distribution, storage, retention, security, and disposition.

The inclusion of risk-based thinking in ISO 9001:2015 has a direct influence on the complexity of documentation required for each organization. Essentially, the greater the risk of uncertainty, the greater the requirements for documentation that effectively captures the complexity of that risk and the full extent of the actions the organization takes to mitigate it.

ISO 9001:2015 is prescriptive regarding the processes that require documentation. This information is located throughout the standard and is not located in a single section, which makes it difficult for the reader to quantify exactly what they need to do. Table 7 shows all the information that requires documentation in ISO 9001:2015:

ISO 90001 2015 course in Pakistan