IAF: Transition Planning for ISO 9001:2015

Posted in Presentations & Papers

IAF logo and sloganThis Informative Document is intended for for companies looking to move to the new ISO 9001:2015 certification.  It also contains transition information fo Certification Bodies (like ASR).

Take a look at section 3.1 "Organizations using ISO 9001:2008"

Organizations using ISO 9001:2008 are recommended to take the following actions:
  1. Identify organizational gaps which need to be addressed to meet new requirements
  2. Develop an implementation plan.
  3. Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organisation
  4. Update the existing quality management system (QMS) to meet the revised requirements and provide verification of  ffectiveness
  5. Where applicable, liaise with their Certification Body for transition arrangements

pdfClick to read the IAF ID 9:2015 document.

You will be able to see some of the work we will be doing over then next few months to prepare for the final publication.


Comparison Matrix between ISO 9001:2015 and ISO 9001:2008

Posted in Presentations & Papers

This free downloadable document shows the differences between the ISO 9001:2015 standard and the ISO 9001:2008 standard.

Purpose / Usage:

The purpose of the document is to highlight the changes between the new and old standard. Use this document to better understand the differences; and to help implement any necessary changes in your Quality Management System. Take your existing QMS, and map where the old standard applies and develop a plan, if necessary, to modify any processes, procedures or definitions with the goal of conformance prior to your next audit.

Intended Audience:

This document is intended for the ISO 9001 QMS Stakeholders in an organization, the Internal Auditors, and the Quality Manger(s).

Copyright:

All rights reserved by American System Registrar. This document may be distributed to any person "as is" without modification. We encourage its use to any and all parties interested in conforming to ISO standards with a goal of maintaining their certification status or seeking their first certification audit.

About ASR:

American System Registrar is an accredited Certification Body for ISO 9001, ISO 14001, ISO 13485, AS9100, AS9120, and ISO/TS 16949. We provide 3rd party audits with the goal of adding value to your organization, not just a certification. ASR is client centered and affordable for every size organization.

pdfDownload the Correlation Matrix Here



A Review ISO 9001:2015 (Revision Update)

Posted in Presentations & Papers

A Review ISO 9001:2015

What’s Important to Know Now

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  • A Review ISO 9001:2015 Draft



    What’s Important to Know Now




    Prepared byASR Logo small
    Rand E Winters, Jr.
    Senior ASR Lead Auditor
    March 2014
  • ISO 9001 – Under Revision


    • Review based on ISO Working Draft 9001 – 6/13.
    • Further revisions likely to occur.
    • Firms may wish to consider these changes and plan accordingly .
    • New revisions slated for release Sept 2015 with full implementation Sept 2018.
    • Draft revisions now 21 pages of requirements compared to 9 pages in the 2008 revised standard
  •  

    Objective of Revisions

    • Enhance an organization’s ability to satisfy customers.Perspective-Checklist
    • Maintain relevance, provide integrated approach to organizational management, and integrate with other management systems.
    • Reflect needs of all user groups and increasingly complex operating environments.
    • Set a consistent foundation for next 10 years.
  • What’s New?


    • Risk management is being added with focus on risk-based thinking.  Identification of risk and risk control now a requirement.
    • Standardized core text, structure, definitions enable organizations with multiple management systems to achieve improved integration & implementation.
    • Major focus on achieving value for organization and its customers.
    • Revisions allow ISO 9001 to be more applicable by “service-based” organizations.
    • Primary focus remains on Customers!
  • What Prompted Revisions?


    • Business and industry has changed.
    • Greater diversity of ISO 9001 users and broader interests of users.
    • Knowledge and technology developments.
  • QMS Structure Re-organized



    4. Context of Organization – addresses needs and expectations of interested businessman-hand-pushing-qualityparties, scope of QMS                         

    5. Leadership – addresses management commitment, policy, roles, responsibility & authority

    6. Planning – includes risks, opportunities, objectives and plans to achieve them, the planning of changes

    7. Support – includes resources, competence, awareness, communication, documented information
  • Structure Re-organized



    8. Operation – includes planning & control, determine market needs, interaction w/customers, planning process, control of external provisions of goods/services, production of goods, provision of services, release of goods/services, non-conforming goods/services

    9. Performance Evaluation – includes monitoring, measurement, analysis & evaluation, internal audit, management review
  • Structure Outlined



    10. Improvement – addresses non-conformity & corrective action, improvement
  • Timeline to Revision Release
    and Client Transition

    Timline-1
  • Timeline to Revision Release
    and Client Transition

    Timline-2
  • What Should an Organization do Now?


    Nothing at this time ( well almost nothing).

    Still too early in the 2015 revision process of ISO 9001 to make any significant changes to an existing QMS.

    Some issues drafted may change or disappear in upcoming drafts or with final version.

    Looking ahead…existing registered system documentation should conform with some small adjustments.  In most cases, existing registered organizations should have enough documentation and records.

    Since risk is documented in most sections of proposed revision to ISO 9001, consider starting your risk management plan, if you don’t have one.  Begin thinking how to address risk in your business.
  • Considering Risk


    • Risk is very detailed in this revision to the standard as compared to ISO 13485, Food Safety, or Aerospace.
    • Think about adding/using words that are typical in the risk process such as risk determination, risk control, risk mitigation, acceptable level of risk.
    • Next slide outlines the four phases of managing risk, and maybe helpful as an organization addresses risk to their business.
  • Four Phases of Risk

    Four-Phases-of-Risk
  • Where Risk is Addressed in 2013 Draft


    • 3.09 Risk - effect of uncertainty (definition)
    • 4.1  Organization shall take account of these issues for determining risk.
    • 4.4 QMS - determine risk if unintended output produced.
    • 5.1 Leadership - ensuring risks that could affect meeting product requirements … managed.
    • 6.1 Actions to address risk and opportunities.
  •  Risk Continued


    • 6.3  Planning and Controlling Changes a) identification of risk and control measures associated with product
    • 8.4  Control of External Processes or Products- evaluation based on risks and risk control
    • 8.5.1  Design and Development, define c) risk
    • 8.5.3  Implement c) risk control measures
    • 8.6  Execution/Implementation  8.6.1h) implementation of risk controls
    • 9.3 Management Review b) determined risks
  • Related Information & Updates


    • Once ISO 9001 is revised, expect to see changes to industry-specific standards and other supporting documents.
    • Monitor ASR’s newsletter and website for future releases of the revisions to ISO 9001.
    • If you have any questions, please contact ASR  at 888-891-9002 or email us at:   This email address is being protected from spambots. You need JavaScript enabled to view it.
    Thank you

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