ISO 9001:2015 – On its Way

Wednesday, 08 October 2014
ASR Editor
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A major rewrite draft of ISO 9001 is circulating through the voting stage. If the latest draft is approved, release is expected in the 4th quarter of 2015 following a final vote sometime mid 2015. Implementation deadline is three years from date of approval making it in a 2018 – 2019 timeframe.

The following is a brief summary of the major changes to ISO 9001. For a broader look at the revised standard and what organizations can do now, ASR has prepared a 20 minute slide presentation with auditor commentary. Click here for more.

What’s prompting this rewrite of ISO 9001? Experts say business and industry has changed, there is greater diversity of ISO 9001 users and broader interests of users, and finally, knowledge and technology developments are growing.

While the lapse between approval and implementation is a long process, organizations might consider taking the three year interlude to learn about this newly crafted document and develop an implementation action plan rather than rushing at the last minute to make changes to the QMS. Consult the ISO website to obtain a copy of the 2015 draft standard.

What is changing is structure and philosophy….

  • structure of the standard and major structural differences your organization will need to implement.
  • philosophical changes or changes in the purpose or scope that your organization will need to adopt.
  • Structural Changes:

    2008 Verson Has:  2015 Draft Requires:

    5 Auditable Sections
    Requires Quality Manual
    Six Procedures Required
    Management Representative
    Preventative Actions
    7 Auditable Sections
    No Quality Manual Required
    System has “Documented Information”
    Management Rep Not Required
    Risk Management

    Structural changes include “Context of Organization” found in Section 4 of the ISO 9001:2015 Draft (release date 2014) and risk management found in Sub-clause 6.1 and 69 definitions that assist in understanding the standard’s intent.

    The 2008 version of ISO 9001 focused on the organization and the customer. 2015 adds stakeholders and external interested parties to the focus.

    A minimum of six procedures were required in the 2008 revision, but 2015 (3.11) is calling for “documented information” allowing an organization to decide what documents are appropriate to implement. However, organizations will need to ensure whatever documentation is created or deleted from an existing QMS still allows for the demonstration of an effectively implemented quality system (QMS).

    Risk Management is a new process for 2015, but may not require a “documented” procedure. An expanded flow chart indicating what information is to be used in decision making might be adequate.

    Calibration is a good example of no additional documentation beyond the purchased computer calibration program. Most of today’s calibration programs catalog individual calibration records by the instrument serial number. This software is designed to document the calibration, maintain outside calibration certificates, schedule the next calibration based upon the organization’s input. Generally speaking, purchased calibration software would meet the requirements of the new 2015 draft without an organization adding further documentation.

    The procedures that your organization developed for the 2008 version should be good for the new ISO 9001:2015. There should be little need to toss out existing procedures in favor of starting from a clean slate.

    A new philosophical change is the defining of an organization’s business environment. 2015 calls this “context of your organization” and is found in 3.24 and 4.1 and defined as:

    Business environment is combination of internal and external factors and conditions that can have an effect on an organization's (3.01) approach to its products (3.47), services (3.48) and investments and interested parties (3.02).

    There are 4 sub-sections to 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 scope of the QMS
    4.4 QMS and its Processes

    In advance of the release of 2015, Top Management should consider defining the organization’s “business environment” as outlined in 4.1 and 4.2.

    If an organization has an adequately defined scope in their existing quality manual, this might be acceptable to meet requirements of 4.3. Additional exclusions would be listed in 4.3.

    4.4 defines product and service. Sequence and interaction documents from an organization’s existing quality manual should meet the 2015 revisions. Some additions might be necessary.

    2015 is not requiring a quality manual. However, the “documented information” an organization develops might provide value if structured to assist the firm in outlining how quality is controlled. No reason why an organization should abandon the concept of a quality manual. How “documented information” is organized is left to the judgment of management.

    This is just a quick highlight of some of the new QMS requirements based on the ISO 9001:2015 draft. Voting is underway to finalize the draft document. Changes to the draft may still occur.

    For now, organizations might want to take time to begin understanding the proposed requirements of ISO 9001 evaluating how much of the 2008 quality system remains relevant and meets the requirements of the 2015 revisions. Beginning to think about a risk management process might be appropriate during the voting stage.

    Click here for a broader review of ISO 9001:2015 now in the voting stage.

    View Articles With Similar Tags

    2015 Revision | Auditing | ISO 9001

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