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Understanding the Requirements of ISO 9001:2015Changes and Opportunities for Your Organization

MARKET UPDATE: REVISED 2016

ISO 9001:2015 CHANGES YIELD IMPROVEMENT OPPORTUNITIES

Change: A Unified FrameworkThe revised version of ISO 9001 features a unified framework — the clause structure — for a generic management system.

This framework, presented in the ISO document Annex SL, is intended to:

» Ensure that all industry-specific management system standards (e.g., quality, environmental, and information technology) have the same look and feel.

» Provide a standard template for professionals engaged in writing or revising standards.

» Provide uniform “shall” requirements that apply across all standards, freeing standard writers to focus on industry-specific requirements.

» Eliminate conflicts, ambiguities, and redundancies arising from different requirements across the various standards.

» Facilitate the integration of various management systems. This is a huge benefit for organizations that must conform to multiple standards.

Opportunity: An Integrated Approach to the Management SystemIndustry-specific standards (e.g., ISO/TS 16949 and AS9100) are expected to migrate to this unified framework at the time of their next revision. This standardization offers organizations the opportunity to improve cycle times and reduce the costs associated with establishing, documenting, maintaining, and improving their management systems.

Change: A New Clause Structure with New RequirementsThe new clause structure begins with the scope (clause 1), which is followed by normative references (clause 2) and terms and definitions (clause 3).

ISO 9001 is the framework for quality management systems at organizations around the world. In use for more than 25 years, it has served as the foundation for many sector-specific standards, such as ISO 13485 for medical devices and AS9100 for aerospace.

Changes to ISO 9001 create significant ripple effects across many industries, and the 2015 issue is no exception. It is expected to have an even greater impact than the 2000 issue, which brought major changes for certified organizations, certification bodies, consultants, and training providers.

Based on the final, published version of ISO 9001:2015, this Market Update explains:

− Major changes in the revised standard

− The opportunity to use these changes to make your quality management system a strategic driver of performance and sustainability

− The transition period for currently certified organizations


CLAUSE 4: CONTEXT OF THE ORGANIZATION

Clause 4 sets the stage for the management system. The organization will use its vision and mission to help define and establish the scope of the management system, as well as determine which (if any) requirements cannot be applied. ISO 9001:2015 preserves most of the requirements in the “anchor” clause 4.1 from ISO 9001:2008.

OPPORTUNITY: This emphasis on context offers top management the opportunity to examine components — such as vision (i.e., desired future) and mission (i.e., why the organization exists) — and link them with the needs and expectations of interested parties who are relevant to the quality management system.

CLAUSE 5: LEADERSHIP

Under this clause, the standard raises the bar for top manage-ment’s engagement with — and commitment to — the QMS. It states specific expectations for top management.

OPPORTUNITY: The revised requirements offer the opportunity for top management to link the QMS with strategy and business results. Too often, organizations “work for ISO.” They work hard to maintain certification, without adding value to the business. The revised standard makes it easier to have “ISO work for the organization,” particularly for those companies that must conform to multiple standards.

CLAUSE 6: PLANNING

This clause includes actions to address risks and opportunities. For instance, based on the organization’s context, leaders may decide to avoid risks, take risks to pursue business opportunities, or share risks with customers and providers. For example, a food sector organization will consider customers, consumers, external providers, regulatory agencies, employees, and the entire supply chain. An example of risk would be the potential deterioration of products during transportation — the organization must decide how to protect the products.

OPPORTUNITY: This clause prompts organizations to consider both business risks and opportunities. An example of a potential business opportunity for a food sector company would be expanding its business in the natural-food channel, which appears to have growth potential.

PLAN

4. Context of the organization5. Leadership6. Planning7. Support

DO

8. Operation

CHECK

9. Performance evaluation

ACT

10. Improvement

The graphic above provides an overview of the remaining clauses that broadly follow the Plan-Do-Check-Act methodology known as PDCA.

PDCA [Plan-Do-Check-Act]


CLAUSE 7: SUPPORT

This clause retains most of the requirements of clause 6 from the 2008 issue. It expands on the original to cover resources from a broader perspective, such as the use of measuring resources. The most interesting additions include:

Changes to terminology » Work environment becomes an environment necessary for the

operation of processes and to achieve conformity of products and services. It includes the physical, social, and psychological environment along with other factors, such as humidity, temperature, ergonomics, and cleanliness.

» The term resources is used in regard to measuring. This is different from the 2008 version, which used the term equipment to apply to monitoring and measuring. This change recognizes that many processes are people dependent, such as the process of flying an airplane or providing health care.

Resource requirements » The clause addresses the need for external resources beyond

internal resources (e.g., external providers).

Communication requirements » There are more prescriptive requirements related to

communication. Organizations must determine what, when, with whom, and how they will communicate regarding the QMS.

Knowledge and document management » There is a new requirement related to capturing and

preserving the knowledge necessary for the operation of processes. This broad new requirement shows a concern with the need to preserve and share knowledge in a way that is commensurate with the business environment.

» The control of both documents and records “collapse” into a single clause (7.5) titled “documented information.” It appears, at first glance, to be less prescriptive with the removal of the requirement for “documented procedures.” What it really does, however, is give the organization more flexibility to decide the most suitable documentation needed based on the context and business environment.

OPPORTUNITY: The changes to this clause give your organization the opportunity to reassess and improve the architecture of the entire documentation structure by considering other, creative ways to communicate (e.g., videos, pictures, models, slideshows) and to improve the enabling processes that impact your operations and products.

CLAUSE 8: OPERATION

The structure of this clause is similar to that of clause 7 in the 2008 issue. The term operation replaces product realization. Accordingly, operational planning and control replaces planning of product realization.

There are two significant additions in areas related to:

1. The control of externally provided processes, products and services (clause 8.4)The changes include more explicit requirements for controls based on whether products or services from external providers are incorporated into the organization’s own products and services, provided directly to the customer, or impacted by a process that is outsourced (e.g., heat treatment, sterilization). In addition to establishing criteria for selection, evaluation, and reevaluation of suppliers, organizations must look at results and performance, which means adding more documented infor-mation in this area.

2. Post-delivery activities (clause 8.5.5)Here, the organization is supposed to determine the post-delivery activities associated with the products or services it provides. The organization must consider factors such as risk, nature, use, and intended lifetime of the products and services. The organization must also consider customer feedback and regulatory requirements. This clause will be of special concern to organi-zations engaged in high-risk or regulated business environments, such as health care or medical device manufacturers.

OPPORTUNITY: The more explicit requirements in this clause present an opportunity to craft more effective supplier management programs and post-delivery activities.

CLAUSE 9: PERFORMANCE EVALUATION

This clause addresses the evaluation of an organization’s processes, as well as the performance of external providers.

Key requirements include:

» An evaluation that goes beyond the “analysis” in the 2008 standard. This type of evaluation uses data and information obtained internally and externally (from external providers).

» The use of data and information to determine process effectiveness. This clause also includes internal audits and management review as performance evaluation tools. While there are no significant changes to auditing requirements, the management review process adds strategic items related to


the context of the organization, risks, and opportunities. Further, “trends” must be used to monitor specific performance indicators. The standard upgrades the management review process, connecting the QMS and overall business performance.

OPPORTUNITY: One consideration for quality professionals and auditors is that conducting data analysis and evaluation may require knowledge of statistical procedures such as statistical process control (to verify process stability) and process capa-bility analysis (to verify process capability of meeting specified requirements). This need is an opportunity to empower your employees with the statistical knowledge and skills to meet these requirements and improve your organization’s overall performance.

CLAUSE 10: IMPROVEMENT

This clause gives improvement a broader context. It includes reactive improvement through corrective action, incremental (continual) improvement, innovation, and transformation via reorganization. It brings nonconformity and corrective action into a single subclause (10.2.1). With the introduction of the risk-based approach to the QMS, this version drops the clause on preventive action. The standard keeps a clause for continual improvement (10.3). However, the 2015 version replaces the use of the quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action, and management review — organizations instead will identify opportunities for improvement by examining the outputs of the performance evaluation required in clause 9.

OPPORTUNITY: As in clause 9 above, these requirements present an opportunity for your employees to acquire enhanced knowledge and skills. Training your staff to use the necessary quality and statistical tools will enhance their skills as they work toward meeting the revised standard’s requirements and improve your organization’s performance.

TIMELINE OF TRANSITION

The International Accreditation Forum (IAF, which monitors certifications/accreditations on a global basis) and the ISO Committee on Conformity Assessment (CASCO) have agreed on a three-year transition period from the date of publication of ISO 9001:2015.

This transition began in September 2015 and will end in September 2018. Organizations currently holding certifications to ISO 9001:2008 will see their certifications expire in September 2018.

All new certifications will be to ISO 9001:2015 from March 2017 forward. Certification bodies will have less than two years (September 2015 to March 2017) to transition their accreditation in order to carry out recertifications or new certifications.

WHAT NEXT? THE PATH FORWARD

With the release of the revised standard, it is time for organi-zations to start planning their transition to ISO 9001:2015.

This transition can take one of two paths: Merely meeting the requirements of the revised standard, or embracing the opportunities created by the required changes and transforming your quality management system into a strategic driver of performance.

WE CAN HELP YOU “EMBRACE THE OPPORTUNITY”

Oriel STAT A MATRIX’s consulting team can help you develop and implement an action plan to turn transitioning to the revised standard into an opportunity to transform your QMS into a performance driver. In addition, we are currently offering two courses dedicated to the revised standard.

Get more information about our training courses by visiting orielstat.com/training, or contact us to learn more about how we can help your organization maximize the opportunity presented by ISO 9001:2015.

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