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The ISO 9001 standard in brief 

An overview of the ISO 9001 version 2015 standard

Quality System or Quality Management System?

The main objective of quality management is to meet customer requirements and strive to exceed their expectations.

Every company develops in response to a market and a demand. The first goal of quality is therefore the correct positioning of the company with respect to this demand in order to ensure the company's sustainability.

Any company that meets the expectations of its customers has a "natural" quality system (even if it is not documented).

This quality system consists of:

  • Through company processes and procedures,
  • By the skills necessary to the realization of its services or products,
  • knowledge, patents held,
  • relations with its suppliers, customers and partners,
  • of its software
  • ...

This complex list is related to what is called the management system.

The ISO 9001 quality management standard specifies the objectives to be achieved by this organizational system.

The management principles of ISO 9001:2015

The ISO 9001 standard is based on management principles that are vectors of improvement for the company.

  • Customer orientation: an organization exists only because it has customers. It is by ensuring their satisfaction that it develops.
  • Leadership: management is the driving force behind the approach and listens to the operational staff. The organization stems from the management's will, the quality approach must be directed by the management.
  • Involvement of employees: taking into account the needs and expectations of employees is a driving force for the company's performance.
  • Process approach: develop a process vision of customer needs until their satisfaction, from one end of the company to the other.
  • Continuous improvement: building a culture of openness, transparency and mutual support to continuously improve the company's results.
  • Evidence-based decision making: updating the company's activities and processes allows the company to be properly oriented.
  • Management of relations with interested parties : pragmatic consideration of interested parties ensures better control of its environment for better performance.
  • Risk and opportunity approach: anticipation is used as a means to better control results. It is an approach to prioritize the risks to be treated and the opportunities to be seized.

Advantages and benefits of the 2015 version of the ISO 9001 standard

In 2015, a new version brought a more managerial and empowering approach to the business.

Benefits of the 2015 version

The 2015 version of the standard directs the organization to:

  • A simplified management system
  • A more empowering approach
  • Directing a client to the center of the system
  • A real progress approach
  • Move towards a more pragmatic approach to quality

The main changes in ISO 9001: 2015

  • Clarification of management responsibilities
  • Clarification of the exercise of responsibilities
  • The search for coherence between the strategy and the implementation of the objectives in the company
  • A stronger consideration of the company's context
  • The risk management approach
  • Reducing formalization requirements
  • Strengthening control over external service providers
  • The knowledge management approach

Risk analysis: a central requirement of ISO 9001

Quality risk analysis is a central requirement of the ISO 9001 standard. There is no prescribed method for performing this analysis. In the future, however, you must ensure that the analysis leads to improvement actions within your company's processes.

Risk analysis is a management tool to initiate preventive improvement actions.

Learn more by reading our article:

iso 9001 Guide : Meeting the requirements of iso 9001 chapter 6.1 - on risks

Identify issues and stakeholders

The company must demonstrate that it analyzes its environment (competitors, partners, innovations...) and its internal functioning in order to use it in the best possible way in a successful strategy. External and internal issues are those that have an impact on products and customers.

Management must be able to explain the relevant internal and external issues that affect its ability to achieve results.

Management should also monitor and review information on issues.

Learn more by reading our article on this chapter of the standard:

ISO 9001 Guide: Understanding the Requirements 4.1 - Understanding the organization and its context

What is the process for implementing ISO 9001?

A sound approach is one that starts from what exists without copying the organization's ready-made practices and that is built from this natural quality system.

The objective of certification (and of the iso 9001 standard) is to put in place a management system that provides the "just necessary and beneficial" for customers and for the organization that allows :

  • Resolve malfunctions identified by operational staff
  • Anticipate and take into account the context (risks / opportunities)
  • Clarify the expectations and contributions of suppliers and support functions in the process approach

The certifier himself does not hold the truth, the methods are to be adapted to the context; one should not hesitate to oppose the auditor with adequate arguments because the objective of an approach is not "more monitoring", "more methods, tools and procedures".