ISO 9001:2015
Quality Management System

ISO 9001

Background and
overview to the
ISO 9001:2015

Quality management system is defined as a set of interrelated or interacting elements to establish policies, objectives, and processes to achieve those objectives with regard to quality.
ISO 9001 applies to all types and sizes of organizations that wish to:
  • Establish, implement, maintain and improve a QMS
  • Assure conformity with the organization’s stated quality policy
  • Demonstrate conformity to others
  • Seek certification/registration of its QMS by an accredited third party certification body; or
  • Make a self-determination and self-declaration of conformity with this International Standard

Quality management standardization evolves with ISO 9001:2015 by adding

  • Greater emphasis on process approach, risk management, monitoring performance and metrics;
  • Better focus on interested parties
  • More careful analysis of the context of the organization needed for ensuring quality improvement

ISO 9001:2015 is the first quality management standard to be fully compliant with the new guidelines from Annex SL (“High level structure and identical text for management system standards and common core management system terms and definitions”). It has been developed in response to standards users’ critics that, while current standards have many common components, they are not sufficiently aligned, making it difficult for organizations to rationalize their systems and to interface and integrate them. This means that ISO 9001 is integrated to the high-level structure and common text that will make it totally aligned with all other management systems once the related standards have also adopted the Annex SL guidelines.


New ISO 9001:2015 Standard

What does the new ISO 9001 look like?

Clause 4

In Clause 4 the organization is required to determine the risks which can affect its ability to meet the system objectives. It recognizes that the consequences of risk are not the same for all organizations. For some, the consequences of delivering a non-conforming product are minor; for others the consequence can be fatal. So risk-based thinking means considering risk quantitatively as well as qualitatively, depending on the business context.

Clause 5

In Clause 5 top management is required to demonstrate leadership and commit to ensuring that risks and opportunities that can affect the conformity of a product or service are determined and addressed.

Clause 6

In Clause 6 the organization is required to take action to identify risks and opportunities, and plan how to address the identified risks and opportunities

Clause 8

In Clause 8 looks at operational planning and control. The organization is required to plan, implement and control its processes to address the actions identified in Clause 6.

Clause 9

In Clause 9 the organization is required to monitor, measure, analyze and evaluate the risks and opportunities.

Clause 10

In Clause 10 the organization is required to improve by responding to changes in risk.


ISO 9001: 2015


Gain leadership commitment. Identify and assess risks. Create plan to address risks and opportunities


Implement your plan to mitigate risks., through communication, training and controls


Implement changes to your approach and continually review opportunities for improvement


Monitor your plans through measurents, internal audit and reporting

ISO 9001

Integration with
other management systems

Link between ISO 9001:2015 and other standards

Various standards such as ISO 9004 and ISO 9000 are used to complement ISO 9001:2015. ISO 9004 provides guidance to organizations to support the achievement of sustained success by a quality manage - ment approach. ISO 9004 standard provides additional guidelines on customer focus, defect prevention, cost control, process approach, documentation, purchasing, informed decision-making, training and em - ployee motivation. In addition, ISO 9000 discusses definitions and terminology and is used to clarify the concepts used by the ISO 9001 and ISO 9004 standards.

Other standards that are closely linked to ISO 9001:2015 are sector specific standards. These standards are meant to complement quality management system in defining best practice within certain sectors, and tackle the issues which ISO 9001 does not cover. Sector specific quality management standards include ISO 16949 (automotive industry), AS 9100 (aerospace industry), TL 9000 (telecommunications industry), ISO 13485 (medical devices), ISO 29001 (oil and gas industry), and so on.


ISO 9001
What are the benefits?

Quality Management – The Business Benefits

The adoption of an effective quality management process within an organization will have benefits in a number of areas, examples of which include:


  • Improved organizational effectiveness and efficiency
  • Improved understanding of the business as gained through risk identification and analysis
  • Operational resilience which results from implementing risk reduction
  • Downtime reduction due to the identification of alternative processes and workarounds
  • Protection of stakeholder value
  • Increase customer and employee satisfaction
  • Increased market share and profit
  • Improved organizational culture
  • Enhanced continuous improvement
  • Process improvement; and
  • Avoidance of liability actions.

ISO 9001


Certification of Organizations

The usual path for an organization that wishes to be certified against ISO 9001 is the following:

1. Implementation of the management system:

Before being audited, a management system must be in operation for some time. Usually, the minimum time required by the certification bodies is 3 months.

2. Internal audit and review by top management:

Before a management system can be certified, it must have had at least one internal audit report and one management review.

3. Selection of the certification body (registrar):

Each organization can select the certification body (registrar) of its choice

4. Pre-assessment audit (optional):

An organization can choose to perform a pre-audit to identify any possible gap between its current management system and the requirements of the standard

5. Stage 1 audit:

A conformity review of the design of the management system. The main objective is to verify that the management system is designed to meet the requirements of the standard(s) and the objectives of the organization. It is recommended that at least some portion of the Stage 1 audit should be performed on-site at the organization’s premises.

6. Stage 2 audit (On-site visit):

The Stage 2 audit objective is to evaluate whether the declared manage - ment system conforms to all requirements of the standard, is actually being implemented in the organi - zation and can support the organization in achieving its objectives. Stage 2 takes place at the site(s) of the organization’s sites(s) where the management system is implemented.

7. Follow-up audit (optional):

If the auditee has non-conformities that require additional audit before be - ing certified, the auditor will perform a follow-up visit to validate only the action plans linked to the non- conformities (usually one day).

8. Confirmation of registration:

If the organization is compliant with the conditions of the standard, the Registrar confirms the registration and publishes the certificate.

9. Continual improvement and surveillance audits:

Once an organization is registered, surveillance activi - ties are conducted by the Certification Body to ensure that the management system still complies with the standard. The surveillance activities must include on-site visits (at least 1 per year) that allow veri - fying the conformity of the certified client’s management system and can also include: investigations following a complaint, review of a website, a written request for follow-up, etc



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ISO 9001:2015 Quality Management System