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ISO 9001:2015
New Ebook

Application guides of ISO 9001:2015. Anticipate and begin to implement the new version of the standard.


About the Author


Lic. Walter Patalano

Lead Auditor ISO 9001 – ISO 14001 – ISO 22000 – HACCP. With extensive experience in the implementation of management systems and audits of second and third party since 1995.

My career in the last seven years has been as a lead Auditor in a body of international certification. This has allowed me to learn about different productive processes, audit and certify over four hundred different products in Latin America business units.

The main scope of this book are the certified organizations according to the requirements of ISO 9001:2008, and is aimed to quality consultants, trainers and quality auditors which shall be certified with the new version of the standard.

With so much information and so many expectations on how to carry out this transition in each company, the challenges are many. Changes there in the new version. Requirements will be eliminated and which will be the new implement. How to adjust the current documentation to the new version.

It is for this reason that I have analyzed every requirement separately from each version of both standards (ISO 9001:2008, ISO 9001:2015) from which resulted a correlation matrix that explains in detail all the questions made above. This matrix is an excellent tool to help because the objective is to facilitate the reader a greater understanding and analysis to adapt the Organization's documents to the new version.

Application Guide Chapter 4: Context of the organization


Edition: 4
Pages: 37
Format: PDF. Support Records in excel and word.

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.

For each requirement, the analysis includes

  • A. Understanding of the requirement.
  • B. Basic concepts and associated foundations.
  • C. The requirement analysis.
  • C.1 Matrix of correlation input ISO 9001:2008.
  • C.2 Matrix of correlation input ISO 9001:2015.
  • D. How to implement the requirement in your organization.
  • E. Examples and case studies.
  • F. Documented information.
  • G. Information to the auditor.
  • G.1 First part audit. Audit questions.
  • G.2 Third party audit. Comments and evidence.

Help Documents to implement

  • Records to analyze and record the interested parties.
  • Registration for analyzing and declare the scope according to the new requirements.
  • Records to specify the processes according to the new requirements.

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