General

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One of the key requirements of ISO 9001:2015 is to ensure you have a process based management system. Globally companies are looking for new strategies that can give them a competitive advantage and adopting this approach is one of the most effective ways.



One of the great benefits offered by a process based management system is it can be implemented in a gradual way. It is possible to start with certain processes or projects which serve as a starting point to extend a quality management system to the entire organization gradually.

1. Identify and sequence processes
Firstly, identify all the different types of processes which occur within the organization. These processes may be strategic, operational or support based. Once the processes are identified the impact they have on the organizations needs to be determined so the processes with the most significant impact or organizational value can be prioritized.

The next step is to document the sequence of these processes in order to observe the input and output elements of each process and the interaction between them. The best way to visualize all this information is through a graphical representation, a process map.

2. Describe and document the processes
Describe the different processes by documenting the activities which make up the process, and the key characteristics of the process. By understanding the process clearly its management and future improvement can be facilitated. Process documentation can be presented in a written or graphical way, through flowcharts which outline the existing relationships. Process tabs can also be used where information necessary for the control of the processes is detailed.

3. Establish measures
Establish indicators and controls to determine how affective processes are. Monitor the indicators throughout the process and document the results

4. Improve the processes
Analyses the results achieved along with the process indicators to understand whether the process has in fact achieved its purposes and if it is possible to improve that process.



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If your organization implements multiple ISO Standards and Quality Systems, automating and integrating these systems with an Integrated Management System is critical for maximizing business efficacy and eliminating workload duplication.

When an organization does not utilize an Integrated Management System the following issues may arise:

  • No simple and automated system to raise a finding which results in:
    • Recurrence of non-conformities
    • Products and services losing quality and credibility to stakeholders
    • Management systems losing all their preventive and corrective efficacy
  • Delays in the management and consolidation of indicators leading to:
    • A loss in productivity
    • A loss of credibility of information reporting systems
    • Erroneous decision making through incorrect data
  • Workload duplication causing:
    • Management Coordinators spends too much time managing the system.
    • A reduction in time-oriented improvement
    • Low motivation due to excessively bureaucratic work
  • Limited communication of system changes which leads to:
    • A lack of control, disorganization, lack of communication
    • Non-conformity in the system produced by documentary errors.
    • Low credibility of our management system against employees, management, customers, suppliers and other stakeholders.
  • Little control of the information generated in the different locations resulting in:
    • Decrease in control by the manager of the management system.
    • Inability to integrate information
  • Excessive time to apply surveys to customers
  • Revenue loss due to reoccurrence of errors
  • Lack of exhaustive analysis of the records and information generated by the system

    Automating and integrating ISO management systems have extensive business benefits including:

    • Simplifies document management which facilitates the deletion of redundant information and prevents duplication of documents and tasks.
    • Facilitates unification of the methods defined by the organization both for internal and external communication,
    • Unification of Training Plan methodologies
    • Streamlines processes for assessments and certification
    • Strengthens the foundations of continuous improvement
    • Reduction of the time spent in conducting audits

    To find a consultant who can assist your business with the integration of multiple standards into an Integrated Management System visit the Consultants Listings page on ISO Update http://isoupdate.com/consultant-listing

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In many organizations (manufacturing or services) the processes present variability, this means they are not completely stable. The ISO 10017 standard seeks to help organizations in the identification of statistical techniques which can be useful in the development, implementation, maintenance and improvement of a quality management system, in compliance with the ISO 9001:2015 standard requirements.

Variability can be confirmed in those quantifiable characteristics of the products and processes, and can be observed at the exit of various stages in the total life cycle of the products.

The main benefit of the application of statistical techniques is they facilitate the measurement, description, analysis and interpretation of variability in the processes, even with a relatively limited amount of data. In fact, statistical analysis of this data can provide a greater understanding of the nature, extent, and causes of variability. This contributes to solve and even prevent problems that could result from such variability.

This is how statistical techniques become tools for the proper handling and use of data available for decision-making, which undoubtedly contributes to the continuous improvement of the quality of products and processes to achieve Customer Satisfaction. These techniques can be applied in various activities, such as market research, design, development, production, verification, installation and service.



ISO 10017: Guidance on statistical techniques for the ISO 9001 standard

The ISO 10017 standard is a technical report that aims to guide and assist any organization in the consideration and selection of statistical techniques appropriate to their needs. It should be noted that the criteria for determining the need for statistical techniques, and the appropriateness of the techniques selected, is a decision subject to each company. The aforementioned techniques can be useful in the development, implementation, maintenance and improvement of a quality management system in compliance with the ISO 9001 standard.

To this end, it is essential that the requirements of the ISO 9001 standard which involve the use of quantitative data are examined, and in this way, the statistical techniques that are useful in applying them to these data are identified and described.

The ISO 10017 standard clarifies that its content of statistical techniques is not complete or exhaustive, and does not exclude the use of any other technique which may be considered beneficial for the organization. It does not try to establish which techniques should be used, nor does it advise on how to implement them. Even this standard specifies that statistical techniques can be applied from qualitative data as long as they can be transformed into quantitative data.

Major statistical techniques that can be used by organizations

  • Descriptive statistics
  • Design of experiments
  • Hypothesis test
  • Measurement analysis
  • Process capacity analysis;
  • Regression analysis
  • Reliability analysis
  • Sampling
  • Simulation
  • Statistical process Control charts (CEP);
  • Fixation of statistical tolerances;
  • Time-series analysis.

From this group of techniques, descriptive techniques (including graphical methods) are an important aspect of many of these techniques.

Application of statistical techniques in accordance with ISO 9001:2015 standard

The chapters in which statistical techniques are required to be applied in accordance with ISO 9001:2015 are as follows:

Chapter 6: Planning, in number 6.1. Actions to address risks and opportunities

Chapter 7: Support, in the numeral 7.1.5. Monitoring and measuring resources

Chapter 9: Performance evaluation, in numeral 9.1. Monitoring, measurement, analysis and evaluation

Definitively, the use and application of statistical techniques is essential for organizations, because decision-making must be based on objective data.

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AS9100 applies to large aerospace suppliers only 

Although only intended to be used by aerospace companies, AS9100 is not meant for only the largest of organizations. Requirements have been determined in a descriptive way, but not by prescriptive means. The standard contains what must be done (requirements), but does not dictate how they must be accomplished by the organization (processes). Therefore, the requirements of AS9100 can be implemented in a way that works best for each individual organization, be they large or small. Using this particular method, the organization is provided with the best possible practices of what the QMS requires to be effective, regardless of the size of the aerospace organization.