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ISO 9001:2015 FAQ

Q – ISO 9001:2015 has been published. What now?

A – Obtain a copy of the Standard. They are available at www.ISO.org

Review the standard in detail and also become familiar with Annex SL. Annex SL establishes a consistent structure featuring 10 clauses and common terminology and definitions applicable to all ISO Management System Standards.

Check out the numerous publications, briefs, FAQ’s, and White Papers offered by Quality Resource Center.

Review the manner in which your organization currently manages the new and significantly changed areas of the standard and how this relates to your quality or integrated management system. Consider a full GAP Analysis performed by Quality Resource Center professional.

Start by putting together an outline as well as a Gantt chart, taking into account milestones and timings for when and how you will upgrade your current management system. Make sure to start including Risk Management in every aspect of planning.

Establish a transition team, identify requirements and a plan for necessary training for key team members, managers, and other leadership. It is imperative that executive Management update their knowledge ISO 9001:2015, as their responsibilities have been significantly expanded.

Q – Who needs to be aware of the revisions to ISO 9001:2015?

A – Determine the key stakeholders who need to be aware of and understand the ISO 9001:2015 revisions:

  1. While there is no longer a requirement for a designated management representative, significant responsibilities still remain; they can delegated by Top Management to the System Manager.
  2. Top Management must understand and engage the leadership aspects of the revised standard.
  3. Key Process Owners must understand their obligations in managing their defined processes and associated Key Process Indicators.
  4. Internal Auditors and Audit Program Managers need to understand their specific requirements.

Q – What changes and revisions have been made to ISO 9001:2015?

A – Annex SL, Annex SL, Annex SL! It is the single biggest change to the ISO 9001:2015 document.

Other new areas include:

  1. Organizational context
  2. Control of externally provided products and services
  3. Formal introduction of a risk based approach (several clauses), among others.

Revisions to the standard include:

  1. Increased emphasis on top management engagement with ISO 9001
  2. Managing change
  3. Performance and evaluation
  4. Management review
  5. Risk Management

Q – How do the changes impact integrated management systems?

A – Annex SL has the goal of aligning ISO 9001:2015, ISO 14001:2015, and ISO 45001 (replaces OHSAS 18001). Since each of the standards share the structure and terminology of Annex SL, integration of these three important standards is much straightforward.

Q – Who are the key internal interested parties for large and medium size organizations in relation to the ISO 9001:2015 revision?

A – The most important internal interested party is top management. ISO 9001:2015 requires much greater understanding of the external environment, including addressing risk as well as greater top management ‘quality leadership’, and establishing tighter links between the management system and product/service quality.

There is increased emphasis on their direct involvement or oversight for the design, implementation, structure and performance of the organization’s management system and to ensure the QMS is an integral part of the organization’s business processes.

Q – How are smaller organizations impacted?

A – All the new and changed requirements will likely apply. The approach and degree of formality should be appropriate to the organization’s operating environment. Bear in mind that an organization should not be doing more than it needs to do to meet its customer and product/ service regulatory requirements but should be achieving this through a management systems approach based on ISO 9001:2015.

Q – When does the transition need to be achieved?

The transition guidance from ISO shows that organizations have three years from publication of ISO 9001:2015 to transition to the new standard. The cutoff point is September 2018. While some may choose their next certification cycle, many will want to be among the first to benefit from the increased functionality that ISO 9001:2015.

Q – What is the bottom line?

Focus on the areas of ISO 9001:2015 that are completely new or have been revised. Those are the areas that need to be included in your transition plan. Make sure that quality managers and internal auditors understand the differences that Annex SL (common text and structure) will bring to the design, operation and performance of your QMS.

Engage a professional –

Talk to Quality Resource Center – We not only understand the revisions, but more importantly, we know what the revisions mean to your QMS and wider organization – and how to apply it to best effect.

Engage with QRC to find out how a gap analysis and training on specific areas of ISO 9001:2015 can benefit you personally, as well as your organization.

Quality Resource Center offers a range of services to help you transition to the revised standards. Find out more at www.qrccentral.ai

 

Still have questions about your own system? See QRC’s ISO 9001 consulting services or book a complimentary consultation.

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Executive Leadership – Increased senior management responsibility in ISO 9001:2015

The common management system framework introduced by Annex SL, ISO 9001:2015 contains a number of changes including standardized terms and definitions as well as a 10 clause structure.

ISO 9001:2015 contains an expanded focus on Leadership; requirements relating to the role top management plays in creating and supporting an effective QMS have been enhanced, including –

  1. Promoting awareness of the process approach
  2. Driving the integration of QMS requirements into the organizations’ business processes
  3. Ensuring the QMS achieves its intended results
  4. Ensuring that the policies and processed are effectively communicated, understood and applied by the entire organization.
  5. Encouraging relevant management roles to demonstrate their leadership

 

Increasing the focus on Leadership in ISO 9001:2015 requires top management to demonstrate a clear understanding of the business context, assessing and ameliorating risks and opportunities, and greater accountability tied closer to links between the management system and actual product/service quality.

Going forward, assessors will challenge the top management of an organization to understand its business strategy and objectives in relation to ISO 9001:2015. This involvement must be demonstrable through internal oversights such as internal audits, which remains an integral part of the assessment. There’s an expectation that top management will be active participants in the ISO 9001:2015 Internal Audit process.

Assessors will actively engage with top management and be capable of communicating the ISO technical requirements in a way that relates to business – effectively bridging the gap between the boardroom and the shop floor.

The independent impartial external view is vital for continued effective operations.

For the top management this represents a requirement for their direct involvement with both the Internal and 3rd party external Auditors and the ability to demonstrate their active involvement and commitment to their system.

The management system can longer be simply delegated to the Quality Manager; requiring the integration of the QMS with the business processes automatically demands the involvement of all process owners.

Summary

Change is inevitable. Embracing positive change is critical for the survival of any organization. These revisions of ISO 9001:2015, along with the focus on top management engagement, will ensure that organizations will benefit from having an effective and performance-based management system that deliver a synergy of business benefits and real competitive advantages.

QRC works directly with executive teams on leadership requirements and management review — see our ISO 9001 consulting services.

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ISO 9001 2015 Analysis

Editor’s note (2026): this article was written during the transition from ISO 9001:2008 to ISO 9001:2015 and reflects the standard as it stood then. ISO 9001:2015 is the edition in force today, with ISO 9001:2026 in development. For current requirements and transition planning see our ISO 9001 consulting services.

I. TIMELINE

  1. ISO 9001 scheduled to be published in September, 2015
  2. All clients need to be transitioned by September, 2018

II. IMPORTANT CHANGES

  1. Published version to very closely mimic the FDIS
  2. Continue to expand language to include and emphasize service organizations
  3. Emphasize Risk Based thinking
  4. Reliance on Annex SL (Part of “ISO / IEC Directives Part 1 – Consolidated ISO Supplement – Procedures Specific to ISO”)

II.KEY CHANGES IN TERMINOLOGY

A. “Procedures”, “Records”, and “Documents” replaced by “Documented Information.”

  1. Allows alternative approaches to these items.
  2. References to “Product” changed to “Products and Services. (Historically Clause 3 of ISO 9001:2008 reads “Wherever the term “Product” appears it can also mean Service).”
  3. Expands the notion of ISO 9001 as applicable to multiple types of businesses, i.e. those with and/or without a tangible or physical product.

B. “Management Responsibility” has become “Leadership”

  1. Advances the concept that Management lead by example and involvement.

C. “Continual Improvement” has morphed into a larger section called “Improvement”

  1. Continual Improvement is no longer the only aspect of improvement; improvement can also be realized through breakthroughs, reactive changes, and reorganizations.)

D. Suppliers, vendors and subcontractors are now defined as “External Providers”

  1. Better accommodates service organizations.
  2. FDIS 9001 Annex A, clause A.8 indicates that “External Providers” includes Outside suppliers, Associate companies, and Outsourcing.

E. Elimination of Required Content

  1. ISO 9001:2015 does not specifically require any of the following:
    a) Quality Manual
    b) Procedures Manual
    c) Work Instructions

Theoretically, an organization can achieve certification without these documents. Auditors will still be required to verify consistency with applicable requirements. Thus, the organization must be prepared to show effectiveness of processes in whatever activity is being reviewed. If this can be demonstrated without a procedure/quality manual, then it is acceptable.

F. Elimination of the Management Representative

  1. “Management Representative” does not appear within the ISO 9001:2015 standard.
  2. The implication is that while this terminology has been eliminated, many of this party’s key functions should now fall to top management itself.
  3. Organizations are encouraged to appoint a “key” person (arrangements for audits, key contact for corrective actions, etc.).

Elimination of Permissible Exclusions

  1. ISO 9001:2015 has removed all verbiage related to “Permissible Exclusions.”
  2. Organizations can now claim any item from ISO 9001:2015 under a “Non-Applicable” designation.
  3. No difference from ISO 9001:2008, other than the scope of what can be claimed for exemption now encompasses the entire standard

Interested Parties

  1. ISO 9001:2015 includes a new term, “Interested Parties”, intended to be applied to all Annex SL based standard.
  2. Definition –
    “Person or organization that can affect, be affect by, or perceive themselves to be affected by a decision or activity.” Examples given include customers, staff, the organization, suppliers, bankers, unions, partners, and even competitors.
  3. Clause 4.2 requires that organization determine who their interested parties are, but emphasizes those “relevant to the quality management system.”

IV. Annex SL

A. Annex SL was first published in 2012, the output of a special committee of the ISO – The Joint Technical Coordination Group (JTCG.)

B. The Annex is a 10 section “blueprint” for authoring all of the ISO family of standards.

C. Annex SL promotes (among other things) utilization of common terms and core definitions.

D. Eventual plan calls for full transition of all ISO standards to Annex SL structure by 2016 or 2017

    Annex SL

    1 Scope

    2 Normative references

    3 Terms and definitions

    4 Context of the organization

    1. understanding the organization and its context
    2. understanding the needs and expectations of interested parties
    3. determining the scope of the quality management system
    4. quality management system and its processes

    5 Leadership and Commitment

    1. general
    2. customer focus
    3. policy
    4. organizational roles, responsibility and authority

    6 Planning

    1. actions to address risks and opportunities
    2. quality objectives and planning to achieve them
    3. planning of changes

    7 Support

    1. resources
    2. competence
    3. awareness
    4. communication
    5. documented information

    8 Operation

    1. operational planning and control
    2. requirements for products and services
    3. design and development of products and services
    4. control of externally provided processes, products, and services
    5. production and service provision
    6. release of products and services
    7. control of nonconforming outputs

    9 Performance evaluation

    1. monitoring, measurement, analysis and evaluation
    2. internal audit
    3. management review

    10 Improvement

    1. general
    2. non-conformity and corrective action
    3. continual improvement

V.RISK

A. The term “risk” is used 16 times in the auditable language of the FDIS 9001;

B. A formal/documented Risk Management Process is NOT specifically required

C. Expands the notion of Risk aversion to one that affects all of the various areas of the Quality Management System.

D. Clause 6.1.1 of the FDIS 9001 standard states:

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

    a) give assurance that the quality management system can achieve its intended result(s)
    b) enhance desirable effects
    c) prevent, or reduce, undesired effects
    d) achieve improvement

E. Clause 6.1.2 of the FDIS 9001 standard states:

The Organization shall plan:

    a) actions to address these risks and opportunities
    b) how to

      integrate & implement the actions into its quality management system processes (see 4.4)
      evaluate the effectiveness of these actions

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1 – Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 – Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

F. What ISO 9001:2008 requirements most directly correlate to Risk Management?

There are a number of activities that are required under ISO 9001:2008 standard that will help demonstrate compliance to Risk Management. These include:

  1. 6 Management Review (an assessment of your overall quality system leading to targeted improvement efforts),
  2. 2.2 Training (an assessment of competency needs with steps taken to ensure that personnel are fully qualified and competent.)
  3. 2.2 Review of Requirements related to the Product (an assessment of customer expectations against your current capabilities with steps taken to resolve discrepancies),
  4. 5.3 Preventive Action (an assessment of potential problems with actions taken to avoid those issues in the first place)

SECTION BY SECTION ANALYSIS

INTRODUCTION SECTION

0.1 – General

Provides an overview statement, intentions on whom the standard benefits, introduces the ideas of Risk Based Thinking, PDCA, and explains four key terms (of which three are formally defined for the first time):

    a) Shall – mandatory requirement (numerous instances);
    b) Should – recommendation (no uses within the auditable content);
    c) May – permission (this term appears once in the auditable content); and
    d) Can – possibility or capability – numerous instances.

0.2 – Seven Quality Management Principles – reference to the ISO 9000 standard is given:

    a) Customer Focus;
    b) Leadership;
    c) Engagement of People;
    d) Process Approach;
    e) Improvement;
    f) Evidence-Based Decision Making; and
    g) Relationship Management.

0.3 – Process Approach

    a) Reinforce the process approach an improved graphic therein.
    b) Reinforces of Plan-Do-Check-Act (PDCA)

0.3.3 – Risk Based Thinking – definition and explanation of importance

0.4 – Relationship with other management system standards (ISO 9000 and ISO 9004)

Sections 1-3 – Not specifically auditable (as before)

Section 4 – Context of the Organization

Similar to ISO 9001:2008 Clause 4.0 – Quality Management System

Key new questions:

    A. What purpose does the organization serve?
    B. Who does it exist for?
    C. Who are the interested parties?
    D. Does any part(s) of the ISO 9001:2015 standard qualify for a “non-applicable” designation?

Section 5 – Leadership

Key new questions:

    A. Is a Leadership structure evident?
    B. Is Leadership accountable for the effectiveness (or lack thereof) of the QMS?
    C. Has Leadership ensured that the Quality Policy/Objectives are consistent with the strategic direction of the company?
    E.Is the QMS integrated into the business processes?

Section 6 – Planning for the quality management system

Key new questions:

    A. Have all risks (and opportunities) been considered?
    B. Have actions been taken or planned for said risks?
    C. With regards to Quality Objectives –
    D. Who will be responsible?
    E. What is the target date?
    F. What is to be accomplished?

Section 7 – Support

    A.Similar to ISO 9001:2008 Section 6.0 – Resource Management
    B. One very slightly new area of content is provided in clause 7.1.6 that asks the following

key new question:

    a.“Has the organization considered changing needs and trends versus its current competency base and determined what is needed for the future?”

Section 8 – Operation

    A. Very similar to ISO 9001:2008 Section 7.0 – Product Realization, and parts of Section 8.0

Section 9 – Monitoring, Measurement, Analysis, and Evaluation

    A. Similar to ISO 9001:2008 Section 8.0 – Measurement, Analysis, and Improvement, includes content from Section 5.0 – this is now where Management Review (5.6) is found

Section 10 – Improvement

    A. Similar to ISO 9001:2008 Sections 8.5.1-8.5.2– Continual Improvement and Corrective Action.

VII. WHAT ABOUT THE OTHER STANDARDS?

    A. Most of the major sector specific standards, including IATF 16949 (automotive), AS9100 (aerospace), and TL9000 (telecommunications) have indicated intentions to transition and continue alignment with ISO 9001. (ISO 14001 will also follow suit, and is being rolled out at the time of this report).
    B. Precise timelines for these other standard updates are to be announced, but a 2016 publication date seems likely for all three.
    C. At present the only major standard not planning to continue alignment to ISO 9001 is ISO 13485 (medical devices,) currently in the midst of its own update with a targeted publication of early 2016

VIII. WHAT SHOULD BE DONE NOW?

    A. Companies at various stages of implementing new quality management systems in accordance with ISO 9001:2008 may question if there is still value in registering to ISO 9001:2008.

    1. Important to note that ISO 9001:2008 still has at least 3 years of usability left in it.
    2. Equally important to note that the very first audits later this year to ISO 9001:2015 may be somewhat challenging for both auditee and auditor.

    B. Companies currently holding ISO 9001:2008 registrations seeking to transition – International Accreditation Forum (IAF) has published an Informative Document (ID 9) which recommends the following steps be taken in a transition to ISO 9001:2015.

    1. Top down Gap Analysis of the ISO 9001:2015 standard to identify the gaps that need to be addressed.
    2. Development of an implementation plan with assigned responsibilities, and milestones.
    3. Review and update of all quality management system documents (including the quality and procedures manual new or revised processes.
    4. Awareness and transition training.
    5. Full system internal audit followed by a Management Review.
    6. Full round of Corrective and Preventive Actions.
    7. Management Review and closure of any open findings should be in process or complete.
    8. Coordination with Registrar for planning transition logistics.

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Glossary of Quality Terms