Iso 9001 2015 Understanding

  • View

  • Download

Embed Size (px)

Text of Iso 9001 2015 Understanding


    Eng. Akram Malkawi

    Abstract ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. This Document helps you to understand the new standard and ease transition.

  • ISO 9001:2015


    A. Understanding ISO 9001:2015 ISO 9001 is the international standard that specifies requirements for a quality management system

    (QMS). Organizations use the standard to demonstrate the ability to consistently provide products

    and services that meet customer and regulatory requirements. It is the most popular standard in the

    ISO 9000 series and the only standard in the series to which organizations can certify. Successful

    businesses understand the value of an effective Quality Management System that ensures the

    organization is focused on meeting customer requirements and they are satisfied with the

    products and services that they receive. ISO 9001 is the worlds most recognized management

    system standard and is used by over a million organizations across the world. The new version has

    been written to maintain its relevance in todays marketplace and to continue to offer organizations

    improved performance and business benefits.

    ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an

    international agency composed of the national standards bodies of more than 160 countries. The

    current version of ISO 9001 was released in September 2015. ISO 9001:2015 applies to any

    organization, regardless of size or industry. More than one million organizations from more than 160

    countries have applied the ISO 9001 standard requirements to their quality management

    systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them

    organize processes, improve the efficiency of processes and continually improve. With the 2015

    version of ISO 9001 you can have an integrated approach with other management system

    standards. Bring quality and continual improvement into the heart of the organization. Increase

    involvement of the leadership team. Introduce risk and opportunity management. Its much less

    prescriptive than the 2008 version and can be used as a more agile business improvement tool. This

    means that you can make it relevant to the requirements of your own organization to

    gain sustainable business improvements. One of the major changes to ISO 9001 is that it brings

    quality management and continual improvement into the heart of an organization. This means that

    the new standard is an opportunity for organizations to align their strategic direction with their

    quality management system. The starting point of the new version of ISO 9001 is to identify internal

    and external parties who support the QMS. This means that it can be used to help enhance and

    monitor the performance of an organization. The new standard will help you become a more

    consistent competitor in the marketplace. It will provide better quality management that helps you

    to meet present and identify future customer needs. It increases efficiency that will save you time,

    money and resources. It improves operational performance that will cut errors and improves profits.

    It will motivate, engage and involve staff with more efficient internal processes. It will help you win

    more high value customers, and achieve improved customer retention with better customer service.

    It will broaden business opportunities by demonstrating compliance

  • ISO 9001:2015


    All ISO management system standards are subject to a regular review under the rules by which they

    are written. Following a substantial user survey the committee decided that a review was

    appropriate and created the following objectives to maintain its relevance in todays marketplace:

    Integrate with other management systems

    Provide an integrated approach to organizational management

    Provide a consistent foundation for the next 10 years

    Reflect the increasingly complex environments in which organizations operate

    Ensure the new standard reflects the needs of all potential user groups

    Enhance an organizations ability to satisfy its customers

    1. Structure and terminology

    The most significant change we will see in ISO 9001:2015 is the new structure. ISO 9001:2015 is

    based on Annex SL the new high level structure. This is a common framework for all

    ISO management systems. This helps to keep consistency, align different management system

    standards, offer matching sub-clauses against the top level structure and apply common language

    across all standards. It will be

    easier for organizations to incorporate their QMS into core business processes and get more

    involvement from senior management. The Plan-Do-Check-Act (PDCA) cycle can be applied to all

    processes and to the quality management system as a whole. The reason for the change is to adopt

    the common approach outlined in Annex SL, the new document that all ISO management system

    standards, including ISO 9001, ISO 14001 and the recently released ISO 27001, must follow.

    Currently, ISO 9001 contains 8 sections, of which four attempt to approximate Plan, Do, Check, And

    Act. The new structure, based on Annex SL, has 10 sections four of which also approximate to plan,

    do, check, and act. All new management system standards will have this common structure.

  • ISO 9001:2015


    New structure:

    1. Scope

    This section describes the scope of the management system standard and will be unique to the

    individual standard. Clause 1 details the scope of the standard and there has been very little

    change to this clause from ISO 9001:2008.

    2. Normative References

    This section references other relevant standards, which are indispensable for the application of

    the document and will also be unique. ISO 9000, Quality Management System Fundamental

    and vocabulary is referenced and provides valuable guidance.

    3. Terms and Definitions

    Section three contains definitions, and while some of these are common terms related to Annex

    SL, other definitions will be unique to the management system standard. All the terms and

    definitions are contained in ISO 9000:2015 Quality Management Fundamentals and


    4. Context of the Organization

    This part is about understanding the organizations purpose, the management system and who

    the stakeholders are. It describes how to set up the management system and is similar in some

    respects to the old section 4 except that it explicitly requires a broader understanding of the

    situation and needs of the business. This is a new clause that establishes the context of the QMS

    and how the business strategy supports this. The context of the organization is the clause that

    underpins the rest of the new standard. It gives an organization the opportunity to identify and

  • ISO 9001:2015

    4 understand the factors and parties in their environment that support the quality management

    system. Firstly, the organization will need to determine external and internal issues that are

    relevant to its purpose, i.e. what are the relevant issues, both inside and out, that have an impact

    on what the organization does, or that would affect its ability to achieve the intended outcome(s)

    of its management system. It should be noted that the term issue covers not only

    problems which would have been the subject of preventive action in previous standards, but also

    important topics for the management system to address, such as any market assurance and

    governance goals that the organization might set. Secondly an organization will also need to

    identify the interested parties that are relevant to their QMS. These groups could

    include shareholders, employees, customers, suppliers, and even pressure groups and regulatory

    bodies. Each organization will identify their own unique set of interested parties and over time

    these may change in line with the strategic direction of the organization. Next the scope of the

    QMS must be determined. This could include the whole of the organization or specific identified

    functions. Any outsourced functions or processes will also need to be considered in the

    organizations scope if they are relevant to the QMS. The final requirement of Clause 4 is to

    establish, implement, maintain and continually improve the QMS in accordance with

    the requirements of the standard. This requires the adoption of a process approach and although

    every organization will be different, documented information such as process diagrams or

    written procedures could be used to support this

    4.1 Understanding the organization and its context.

    A new requirement; one of several that might suggest a greater union between the QMS and

    wider business planning activities. Requires organizations to ascertain, monitor and review both

    internal and external issues that are relevant to its purpose and strategic direction, and hav