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ISO 9001

Next Steps in the ISO 9001:2015 Revision Process

Next Steps in the ISO 9001:2015 Revision Process

The DIS phase (Draft International Standard) is the first major step in the ISO publication process. The DIS ISO 9001 revision 2015 was officially issued for public comment in early May 2014. The next steps will be the review and discussion of changes before the issuance of the FDIS (Final Draft International Standard), expected in November 2014, and the publication of ISO 9001:2015 in September 2015.

The transition period for introducing and adopting the new requirements for organizations with ISO 9001 certification will start after the new version’s publication in September 2015 and organizations will have three years to implement these into their management systems.

While the DIS is not the final release, it does reflect changes to existing requirements. As the revision process goes forward, the later FDIS will likely have minor amendments included before the final revision is issued. Quality Resource Center recommends that all organizations start familiarizing themselves now with the actual requirements of the DIS version.

What are the main expected changes to ISO 9001?

ISO 9001:2015 will have a modernized approach to quality management, characterized by the following:

  • An increased emphasis on achieving value for organizations and customers. The new version will be more results- and improvement-oriented
  • The new version will also have a distinct emphasis on risk management and risk-based thinking
  • Increased requirements for feedback from all involved stakeholders and processes (not only from clients)
  • Greater emphasis on involvement of top management
  • A revised structure to align with all other ISO management system standards and facilitate integration with other management systems
  • The standard will be more readily applicable by service industries and organizations
  • More flexibility on the type and use of documentation; simplified requirements for documented procedures (no longer a “quality manual”)
  • What has not changed is that the customer remains the primary focus

Quality Resource Center will publish information on new developments on a regular basis. Our team is available to support you with this transition and can provide further information and assistance on this new draft standard.

Selecting ISO 9001 Consultants

Selecting ISO 9001 Consultants and What They Can Do For Your Organization

Utilizing a proven, successful ISO 9001 Consultant will maximize your odds of achieving success in designing and deploying an effective Quality Management system that delivers real value to your organization.

Selecting the ISO 9001 Consultant

You want someone who you are comfortable with.

  • Do they have experience? Look for companies that have a long history of success with multiple types of clients.
  • Can you work with them? Organizational chemistry is an important component of success in working with a consultant organization. Make sure you mesh with the vendor you choose.
  • Are they an individual or do they represent a firm? Check out the team you’re offered.
  • Are they “Virtual” or do they have a real brick and mortar presence? This is another way of establishing their longevity and stability as an organization.
  • Are they a “one trick pony” or do they provide the variety of complementary services that will ensure the healthy growth of your systems as your company grows? – look for vendors that can support and train your company in all the major ISO 9001 based Quality Management Systems

Implementing ISO 9001:2008 enables continual improvement of your organization’s processes and quality management systems (QMS), and improves the ability of your operations to meet customer requirements and expectations.

Demonstrating real commitment to product and service quality can transform your corporate culture because, as a result, employees understand the requirement for ongoing improvement and that will help your bottomline.

ISO 9001 Consultants will help your organization understand the essentials of ISO 9001:2008

  • Understand the benefits of a QMS
  • Know the purpose of ISO 9001:2008 and the ISO 9000 series of standards
  • Gain familiarity with the eight quality management principles
  • Know the factors that make an effective QMS
  • Understand requirements for key clauses of ISO 9001:2008 

Experienced ISO 9001 Consultants will help you understand essentials of the Quality Management Systems Auditing Process

  • Understand fundamentals of quality management systems
  • How to maximize the effectiveness of the Auditing Process
  • How to uncover and realize the value
  • How to couple Internal Auditing with Continual Improvement
  • Understand management systems
  • Gain familiarity with basic skills of the auditing process

Who Should Work With an ISO 9001 Consultant?

  • Management professionals and employees involved with the implementation of a quality management system
  • Professionals seeking to enhance their basic knowledge base, or looking   for a refresher
  • Quality Managers and Management Representatives seeking to implement ISO 9001 Quality Management Systems

What can working with the ISO 9001 Consultant help you learn and understanding ISO 9001:2008?

An experienced ISO 9001 Consultant will explain the clauses of ISO 9001:2008 in detail, and provide a foundation for understanding Quality Management Understand quality management definitions, concepts, and guidelines

  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 9001:2008 standard
  • Understand the eight Quality Management Principles
  • Understand the process approach
  • Supervisors
  • Recognize the role of management
  • Recognize the benefits of a quality management system
  • Understand how to register a quality management system
  • Laboratory quality professionals

What can working with the ISO 9001 Consultant give to the Executive Team?

Outline and demonstrate how management can support and optimize an ISO 9001 process-based quality management system, as well as the role of, and benefits to, top management members; A clear understanding of the five clauses of ISO 9001 with an emphasis on clause 5, “Management Responsibility.”

How does the ISO 9001 Consultant Assist in Implementing ISO 9001:2008

Developing the concepts needed to understand, deploy, and implement a quality management system.

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 9001:2008 standard
  • Build an efficient and effective quality management system
  • Learn best practice processes to implement each clause of ISO 9001:2008
  • Learn tips for winning employee and management support
  • Prepare for an audit
  • Plan for registration

What else can my ISO 9001 Consultant do for me?

They can help you and your Organization understand why Quality Management Systems are Important as well demonstrate your organization’s commitment to quality. And you’ll discover how regular assessments ensure your organization continually uses, monitors and improves processes. You will understand how Certification has proven its potential to help boost business performance, reduce uncertainty, and increase market opportunities and profitability.

How can my ISO 9001 Consultant Help Me Build a Foundation for Effective Management, Continual Improvement and Financial Return?

Formal, internationally-accepted management system standards are critical to the profitability of many organizations.

Organizations who adopt ISO 9001 realize faster sales and employment growth, and are more likely to survive than non-adopters.

ISO 9001 is a foundation for effective management, continual improvement and financial return. As a management representative or quality manager, it is up to you to make a business case for adopting ISO 9001. Any concerns about the ROI should be dispelled when it is over. However –

If you are certified to ISO 9001 and not recognizing a ROI, an ISO 9001 Consultant can show you why – Reviewing and re-evaluating your quality management system, metrics and continual improvement process should help you realize the advantages being realized through your ISO 9001 process, and how implementing ISO 9001 solutions can improve operations, compliance and ultimately the bottom line.

Establishing a Foundation for Effective Management, Continual Improvement and Financial Return.

An ISO 9001 Consultant can help you understand PDCA –

Plan–Do–Check–Act or plan–do–check–adjust (PDCA) is an iterative four-step management method used for the control and continuous improvement of processes and products across many industries.

One of the key concepts of any Quality Management System it is addressed in Section 4 of ISO 9001. The ISO 9001 standard is based in the PDCA cycle, which is adopted by all ISO quality and environmental standards. Plan, Do, Check, Act.

Just remember to make sure you select a consultant organization that is experienced, has good synergies with your company, and can support all of your ISO certification needs.

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Considering ISO 9001:2008 or ISO 9001:2015 Certification? we invite you to contact Quality Resource Center for a complimentary consultation Toll Free at (800) 244-5409 or Email Us.

Latest Developments in the ISO 9001 Revision Process

Latest Developments in the ISO 9001 Revision Process

June 27, 2014 – The latest developments in the ISO 9001 revision process arrived with the issue of ISO/DIS 9001. While the formal draft describes the requirements outlined in the revised version of ISO 9001 it is not the final version. However, it does give an indication on what might be included. Caution – further changes are likely before final publication of ISO 9001:2015 which is currently scheduled to be released in Q4 2015.

As previously noted – the main areas of changes proposed in ISO/DIS 9001 are:

  1. Structure and terminology, including incorporation of  Annex SL framework;
  2. The wider internal and external context of an organization’s Quality Management Systems (QMS) (Clauses 4 and 6);
  3. Detailed Quality Management System (QMS) requirements’ (broadly clauses 5 & 7 – 10)

1. Structure and Terminology: DIS adopts Annex SL, notable changes in terminology

ISO/DIS 9001 adopts the new clause structure specified in Annex SL which is now the required framework for all new and revised ISO Standards. This is to ensure that the final version of ISO 9001 is aligned and harmonized with other management systems standards. Following Annex SL structure presents QMS requirements in a more consistent, rational manner and not simply a template for elements of an organization’s QMS.

ISO/DIS 9001 contains some notable changes in the terminology used in ISO 9001:2008:

ISO 9001:2008 ISO 9001:2015 (DIS version)
‘Products’  ‘Products and services’
‘Documentation’ ‘Records’  ‘Documented information’
‘Work environment’ ‘Environment for the operation of processes’
‘Purchased product’ ‘Externally provided products and services’
‘Supplier’ ‘External provider’

In addition, there would no longer be any requirement to identify any ‘Exclusions’, i.e. QMS requirements that could not be applied due to the nature of the organizations business (clause 1.2 in ISO 9001: 2008).

2. Organizational Context: Quality Management Systems to be more externally oriented

ISO/DIS 9001 requires organizations establishing a QMS to

A.    determine relevant internal and external issues,

B.    understand the needs and expectations of interested parties,

C.    specify the scope of applicability of the Quality System

D.    consider these aspects together in order to properly understand the risks and opportunities and they present

The proposed changes in methodology require a move away from a purely inward-focusing approach to QMS development and implementation to one where external or ‘outside’ factors have a greater influence on the way in which the QMS is focused and prioritized; to be as effective as possible in meeting key internal and external objectives. An organization seeking to implement a QMS needs to determine the interested parties relevant to its QMS and their requirements.

Another important change is the adoption of a risk-based approach when developing and implementing its QMS. Organizations must identify the risks and opportunities that need to be addressed to ensure that the QMS can achieve its intended outcome(s) including those relevant to or determined by its organizational context. Organizations must plan actions to address these risks and opportunities, integrate and implement them into its QMS processes and evaluate their effectiveness.

3. Numerous changes to QMS Requirements

In addition to the adoption of a risk-based approach, there are several other new requirements:

A.    Organizations implementing a QMS must identify the necessary competence for personnel doing work that affects its quality performance, and ensure that they are competent to do so.

B.    A requirement to identify and maintain the knowledge needed to ensure the Organization achieves conformity of products and services.

C.    While ‘Preventive action’ is no longer a specific clause in ISO/DIS 9001, it is now the primary objective of a risk based QMS.

ISO/ DIS 9001 fully expects organizations to apply a process approach when planning, implementing and developing their QMS. It specifies requirements identifying the quintessential elements of such an approach, as well as the key aspects of their interaction(s).

How can Quality Resource Center HELP?

Quality Resource Center provides training to assist our clients in understanding the requirements of ISO/ DIS 9001. Quality Resource Center offers ISO 9001 Consultants and ISO Consulting Services. Quality Resource Center offers a broad array of training and certification services, as well as Internal Auditor and Auditing expertise.


A copy of the ISO/DIS 9001 standard can be purchased.

The official ISO 9001:2015 working group (ISO/TC 176/SC 2) responsible for the development and publishing of the ISO 9001:2015 standard will develop a matrix showing a correlation between the clauses of ISO 9001:2008 and ISO/DIS 9001:2015.

ISO 9001:2015 – Where Are We?

ISO 9001 is currently undergoing its’ first major revision in nearly 15 years. It’s an exciting time in the Quality world.

According to the draft design specification, the revised ISO 9001:2015 standard should (among other things):

  • Provide a stable core set of requirements for the next 10 years or more
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

The revised Standard has significantly upgraded the clause structure as follows:

  • Clause 1 – Scope
  • Clause 2 – Normative references
  • Clause 3 – Terms and definitions
  • Clause 4 – Context of the organization
  • Clause 5 – Leadership
  • Clause 6 – Planning
  • Clause 7 – Support
  • Clause 8 – Operation
  • Clause 9 – Performance evaluation
  • Clause 10 – Improvement




Per Nigel H. Croft – Chair – ISO/TC 176/SC 2, Quality systems


Significant Changes in ISO 9001 Revision 2015 Committee Draft

1. The term “product” has been replaced by “goods and services”.

2. Two new clauses related to the context of the organization:

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties.

3. The requirement to use the process approach has been more explicit by adding a new clause.

4.4.2 Process approach

4. The standard does not include a specific clause for “Preventive Actions”.

5. The terms “document” and “records” have been replaced with the term “documented information”.

6. Control of external provision of goods and services address all forms of external provisions.

7. The term “continual improvement” has been replaced with “improvement”.


That is quite significant.


More to come in our next BLOG…