What is the HLS High Level Structure of ISO 9001?
Here you can find out everything about the HLS High Level Structure for management systems, such as the QM standard ISO 9001. There are numerous standards for management systems – ISO 9001 in quality management, ISO 14001 in environmental management, ISO 45001 in occupational safety An ever increasing number of sector-specific standards resulted in a certain proliferation of concepts and definitions, which also made the contradictions and redundancies between the individual standards more and more obvious.
If companies have introduced more than just one of the standards, acceptance – understandably – was not necessarily given. The ISO, the International Organization for Standardization, has recognized this problem and founded a working group in 2006 to ensure standardization. This published Annex SL in the “ISO / IEC Directives” in 2012 and thus introduces the new high-level structure.
What are the goals of the new High Level Structure HLS?
The introduction of the High Level Structure not only created a uniform basic structure for all ISO standards. Identical requirements and text modules as well as common terms and definitions will also make work easier in the future. All new ISO management system standards now have a coherent core in common. A common structure was created for the table of contents with identical chapters (numbers and titles), articles or clauses, etc. introductory texts for identical articles. The “wording” for identical requirements was coordinated and common provisions and core statements were introduced. In this way, the ISO can guarantee that the different standards do not contain an excessive number of redundant regulations.
Which sections does the high level structure have in the quality management standard ISO 9001?
As the first management system standard, ISO 9001 benefited from the 2015 revision from the new structural structure in accordance with HLS. This structure of the HLS is compatible with the process-oriented approach as well as with the PDCA cycle (Plan-Do-Check-Act). Section 0.3.2 of ISO 9001 illustrates in Figure 2 how sections 4 to 10 are integrated into the PDCA cycle. Section 5 plays a central role in the PDCA cycle, as the top management must show commitment with regard to the entire QM system. The further description of the new high level structure as well as the identical text modules, common terms and definitions for all management system standards can be found in the ISO / IEC directive, part 1, appendix SL, normative annex 2.
- Section 1: Scope
- Section 2: Normative references
- Section 3: Terms
- Section 4: Context of the organization
- Section 5: Leadership
- Section 6: Planning
- Section 7: Support
- Section 8: Operation
- Section 9: Assessment of performance
- Section 10 improvement
Section 4 of the High Level Structure ISO 9001 – Context of the Organization
Section 4 of the new HLS deals with the context of the organization. The aim of the requirements of this section is to understand the purpose of the activities of an organization. With these ISO 9001 requirements, companies have to think outside the box. The framework conditions relevant to the activity of an organization in the area of application of the quality management system are to be determined here by determining the internal and external factors and requirements that have an impact on the planning of the quality management system. In addition, the interested parties with their requirements and expectations must be identified. The context of the organization thus becomes an important consideration when designing and adapting the management system to the requirements of the respective company.
4.1 Understanding the organization and its context
Recognition of the environment in which the organization operates. To this end, internal and external issues that are relevant to the strategy and the QM system must be determined and monitored. Examples: economic, legal, technical, competitive or social issues, etc.
4.2 Understand the needs and expectations of interested parties
Identification of interested parties who are relevant for the QM system and determination of the possible influences of these parties on the products and services of the organization. Examples: customers, employees, suppliers, cooperation partners, authorities, etc.
4.3 Definition of the scope of the quality management system
Determine system limits and applicability of the standard requirements. In doing so, the internal and external issues, the relevant interested parties and the products and services of the organization must be taken into account. The inapplicability of standard requirements must be justified.
4.4 Quality management system and its processes
Build, implement, maintain and improve the QM system with the required processes – taking into account their interactions. The application of the processes within the organization is to be determined on the basis of criteria defined by the standard.
Section 5 High Level Structure in Quality Management ISO 9001 – Leadership
With the current edition of ISO 9001, the top management is made even more responsible than before. The HLS also dedicates a whole chapter to the top one with Section 5 “Leadership”. The top management should form the mindset for quality management according to ISO 9001 and show the way. If quality management is introduced in the company, the company management has a control instrument at hand. It is therefore a clear management task to maintain a QM system and strategically develop it.
The top management must take action itself and align the system to the company’s purpose in general (such as shared values, mission statement, ethics) and to the respective short, medium and long-term goals in detail. Top management should be actively accountable for everything.
This QM principle promotes the culture of trust and mutual commitment. Since everyone involved can focus their actions on the given direction, the company’s goals are achieved more effectively and efficiently. The prerequisite is that the employees are equipped with the necessary resources, the competence and the necessary authorizations. The associated ability to act contributes to higher employee motivation. Furthermore, the role model function of managers at all levels is a decisive factor for success. The ISO 9001 requirements from section 5 include:
5.1 Leadership and commitment
The top management must show commitment to the QM system by assuming accountability and other proactive activities that support the QM system. Example: Communicating quality policy, promoting risk and process orientation, providing resources, communicating the importance of quality management, monitoring the results of the QM system, instructing people and supporting managers, promoting improvement.? The priority of customer orientation and the importance of fulfilling the Customer requirements as well as legal and official requirements must be conveyed and understood in the organization.
Formulation of an organization-specific quality policy – appropriate to the context – with the obligation to continuously improve and publicize it in the organization.
5.3 Roles, responsibilities and authorities in the organization
Allocation and disclosure of which persons have which roles and which responsibilities / authorities (also from the perspective of the standard) are associated with the roles, so that this is understood in the organization.
Section 6 of the High Level Structure in Quality Management ISO 9001 – Planning
With the 6th section “Planning”, the high level structure pursues the goal of companies creating the framework for their QM system with foresight and thus providing orientation. The so-called risk-based approach has a special position in the current QM standard ISO 9001. It is now necessary for companies to identify the risks and opportunities that have an influence on the quality management system being able to achieve the desired results. Risk-based thinking should consider risks and opportunities right from the start and throughout the entire process chain.
6.1 Measures for dealing with risks and opportunities
As part of the planning of the QM system, the organization must follow the steps in 4.1 and 4.2. consider the mentioned topics in order to reduce dangers and to use possibilities so that the desired results can be achieved and the quality management system is continuously improved. The measures must be proportional to the possible impact on the conformity of the products or services.
6.2 Quality goals and planning to achieve them
Measurable quality goals in accordance with the quality policy are to be defined for the relevant functions, levels and processes and measures are to be planned in order to achieve the defined goals. The Q objectives are to be monitored, communicated and updated if necessary.
6.3 Planning of changes
Any necessary changes to the QM system must be carried out in a systematic and planned manner. In the event of changes, the purpose and consequences, the integrity of the QM system, the availability of resources and the responsibilities must be taken into account.
Section 7 of the High-Level Structure in Quality Management ISO 9001 – Support
In section 7 “Support”, the HLS takes the perspective of the support processes into account. As part of the quality management system, a distinction is made between the 3 types of process management, core and support processes. Supporting processes are characterized by the fact that they do not contribute directly to value creation, but are absolutely necessary for value creation. This section of the High Level Structure therefore aims to provide a suitable framework for the core processes. The ISO 9001 requirements from the Support section include the following points:
Determination and provision of personnel, suitable infrastructure, the necessary environment for the processes, resources for monitoring and measurement and the knowledge required to carry out the processes.
Ensuring the competence of the staff. The required competence is to be determined and ensured; if necessary, measures are to be initiated and their effectiveness assessed.
Create the necessary mentality in the staff working for the organization (quality policy, goals, own contribution to QM as well as consequences of errors).
Regulate internal and external communication on the aspects of the QM system. Determination of what, when, with whom, how, by whom is communicated.
7.5 Documented information
The documented information required by the standard must be controlled. ? For this purpose, this must be available (= maintenance of specification documents)? And kept (= verification documents).
Section 8 of the High-Level Structure in Quality Management ISO 9001 – Operation
The requirements of the high-level structure from Section 8 “Operation” are intended to ensure that the product or services are provided in accordance with customer requirements and the specifications of the company. For this, companies have to set up, implement and maintain processes so that the requirements for the quality management system are met. The quality management standard ISO 9001 pays special attention to the special circumstances of a service, ie the presence or cooperation of the customer or his object of disposal. People are no longer just talking about products, but about products and services. This is to take into account the special importance of the service sector:
8.1 Operational planning and control
Planning and control of the processes for the provision of products and services.
8.2 Requirements for products and services
Regulated communication with the customer as well as determination, review of feasibility and, if necessary, changes to the requirements for products and services.
8.3 Development of products and services
Elaboration and implementation of a development process with control, inputs and outputs, which enables the subsequent production / service provision.
8.4 Control of externally provided processes, products and services
Control and information from external providers so that the requirements for externally provided products, processes and services are met.
8.5 Production and service provision
Execution of production and service as well as activities after delivery under controlled conditions, especially labeling / traceability, property of customers / suppliers, preservation, change monitoring.
8.6 Approval of Products and Services
Verification of the fulfillment of requirements for products and services before release.
8.7 Control of Non-Compliant Results
Prevention of unintentional use / delivery of incorrect results.
Section 9 of ISO 9001 High Level Structure – Performance Evaluation
Regardless of whether you have introduced a quality management system in accordance with ISO 9001 or another management system in the company – the goal must be that the system is effective and the specified quality goals are achieved. HLS pays particular attention to this point with Section 9 “Evaluation of Performance”. The requirements of this section of ISO 9001 are intended to provide information about the results of the QM system and any need for action.
9.1 Monitoring, measurement, analysis and evaluation
Monitoring and measurement of the organization of certain criteria based on defined criteria, methods and times. The customer’s perception is to be monitored with regard to the fulfillment of customer requirements. The analysis results of the data as well as information are to be assessed in relation to the conformity of the products and services, customer satisfaction, quality performance, the effectiveness of planning and the measures taken, the performance of external providers and the existing need for improvement.
9.2 Internal audit
Review of the QM system by the organization itself in order to determine whether the system complies with the requirements of the standard, meets the organization’s own requirements and has been effectively implemented and maintained.
9.3 Management review
Evaluation of the quality management system at planned intervals by top management in order to determine its suitability, appropriateness and effectiveness and, if necessary, to adjust it to the strategic orientation.
Section 10 of the High-Level Structure in Quality Management ISO 9001 – Improvement
Constant improvement is the prerequisite for sustainable corporate development. Because if organizations want to be successful, they have to focus on continuous improvement. Successful companies perceive changes in internal and external framework conditions as an opportunity and then improve their processes, which consequently leads to better products and / or services. Maintaining an existing level of performance by responding to changing conditions requires harnessing opportunity through improvement. Once processes have been implemented, you should regularly question them and align them with changing customer requirements. Needs for improvement can also arise from the experience and detailed knowledge of the employees, which, for example, indicate the risk of errors. With consistent implementation of the principle of improvement, you can ultimately significantly increase the performance potential of a company.
Determination and selection of opportunities to improve products and services and initiation of necessary measures to meet customer requirements and increase customer satisfaction and prevent, reduce or correct undesirable effects.
10.2 Non-Conformity and Corrective Actions
Responding to nonconformities – including complaints – with actions to address the consequences, determine the root causes of the problem, and take effective corrective actions to prevent the same problem from occurring again. The measures must be appropriate to the impact of the problem.
10.3 Continuous improvement
Continuous improvement of the suitability, appropriateness and effectiveness of the QM system through the use of opportunities that were recognized in the context of the analyzes and evaluations.