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ISO 9001:2015 Requirement

ISO 9001 is the global standard certification that enhances the consistency and quality of deliverables by organizations spread across industries. It is one of the most sought after standards worldwide. However, an enterprise has to demonstrate high-level of commitment and consistency to achieve it in the first attempt. Since its inception in 1987 when the first draft was published by the International Organization for Standardization (ISO), several revisions have been made so far to make it relevant and contemporary. The latest revision is published in September 2015. ISO is an international organization based in Geneva Switzerland with more than 160 member countries.



Contact us at info@lakshy.com to identify ISO 9001:2015 requirements applicable to your organization.

What all is needed for ISO 9001:2015 certification?

Since ISO 9001:2015 applies to a variety of industries irrespective of size, and type of business; it has universal applicability. According to estimation, more than a million industries have accredited for it in the world. The certification improves organization processes and procedures and improves efficiency drastically. ISO is a continuous improvement process. Hence, organizations are advised to upgrade the certification on a timely basis. ISO certification can be done by an organization on a standalone basis, but it is better if a competent consultant like Lakshy Group of companies covering Lakshy Management Consultant Pvt Ltd, Sterling International Consulting and Infomatics Consultancy is hired. It can offer complete guidance to make the certification smooth and easy.

QMS Structure

Organizations that are already certified for ISO 9001 should upgrade to 2015 version because it widens the horizon of applicability and relevance. As per ISO norms, a transition period of three is given to ISO 9001:2008 certified organizations. Organizations should apply the principles of quality management for enhancing the business in such a way that a sustainable business improvement can be obtained. It is the biggest benefit of ISO certification. ISO 9001:2015 is beneficial for small, medium and large organizations across industries.

Clause # Title Content
1 Scope
  • Similar  to ISO9001 : 2008 with the introduction of the term "goods and services" as opposed to " products"
2 Normative references
  • Similar to ISO9001 : 2008
3 Terms and definations
  • Many terms are defined  and in this section; need to wait to see if they  stay or get moved to ISO9000
4 Context of the organization
  • Need to define the organization's "purpose, scope,enviornment, systems and interested parties"
  • Expect the QMS to focus on " risks and threats"
5 Leadership
  • Roles and Responsibilities" need defining
  • Policies and objectives" need to be established
  • Similar to  current Section 5 (ISO9001 : 2008) but no "management representative"
6 Planning
  • Focus on how to address "risks" and "opportunities"
  • Included are "structured planning  processes", planning for change , and clear planning objectives"
7 Support
  • Includes section on "Infrastructure, work enviornment , and control of monitoring  and measuring  equipment."
  • Includes terms focussed on " competence , awareness, communication" and a new concept called "knowledge"
  • Documented Information" is in this section; "quality manual" and "documented procedures" are not specified.
8 Operation
  • This is the current (9001 : 2008) Clause 7.0 Product Realization plus non conforming product (8.3)
  • Clause 8.5 is a new version of the current 7.3 (Design and Development)
9 Performance Evaluation
  • This clause includes "monitoring, measuring, analysis and evaluation"
  • Internal audits, management review and customer satisfaction perception" are in this section
10 Improvement
  • Focus on the improvement of "suitability, adequacy, and effectiveness"
  • Corrective action" identified
  • Preventative action" and the term " continual improvement" is not in the CD draft

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