The International Organization for Standardization published ISO 9000 in 1987 as a collection of standards for developing quality management systems. The family of standards outlines seven guidelines that businesses should adhere to in order to guarantee that their quality management system continually produces high-quality final goods or services and adds value for all stakeholders.
The five different standards that make up ISO 9000 are ISO 9001, which specifies the requirements that businesses must meet in order to receive ISO 9001 certification, and ISO 9000, which deals with the fundamental ideas that should guide a quality management process. The only standard in the group that has anything to do with certification is ISO 9001.
With over 1 million companies having obtained certification since its establishment, ISO 9000 is the most important set of quality management standards globally, applicable to businesses of all sizes and operating in nearly all industries.
What is a Quality Management System (QMS)?
A collection of procedures known as a quality management system is intended to guarantee that a service or product reaches an ideal or anticipated standard. Documentation created to institutionalise the procedures and roles necessary to fulfil these quality objectives should support the system.
A well-designed QMS should serve as a basis for fostering continuous improvement while also assisting in delivering results that are satisfying to customers and stakeholders. In order to produce high quality service or product outcomes, it should also be aware of limits, such as compliance requirements, financial realities, and cost changes.
What’s involved in creating an ISO 9001-certified Quality Management System?
After going over some of the basic terminology, let's look at the suggested method for developing a reliable QMS and the qualities it needs to have in order to be certified according to ISO 9001.
Before outlining the certification requirements, ISO 9001 advocates a number of ideas that are helpful for creating a QMS that accomplishes its goals. These consist of:
The Process Approach
Organizations are urged to map out their processes in a way that takes into account the steps and inputs that are essential for each of them, as well as the dependencies and interactions that take place between various processes. The purpose of this exercise is to highlight the procedures, factors, and actions that are essential for producing the intended result.
This idea urges firms to think about the risks each process entails, assess whether each situation allows for risk reduction, and decide whether the risk-to-reward ratio justifies each procedure. The implementation of a thoroughly documented risk management process that tracks all discernible risks and the management strategies in place to address them is a requirement for ISO 9001 certification.
The PDCA Cycle
The 'plan, do, check, act' cycle is a procedural model created to help with implementing ongoing changes. 'Plan' focuses on the goals, the parties involved, and any constraints; 'do' entails putting the changes into action; 'check' entails assessing how well the changes have worked; and 'act' denotes taking any corrective action required to produce the desired results. It's important to note that each of the seven certification criterion clauses can be allocated a place on the PDCA cycle before we study them.
What are the criteria for ISO 9001 certification?
Seven of the ten clauses in ISO 9001:2015 are related to the qualities a QMS must possess to be certified. For the sake of this article, we will omit the first three clauses because they provide information rather than instruction.
Clause 4: Context of the Organisation
Clause 4 mandates that the QMS take into account all relevant parties (both internal and external) and influential factors (both internal and external) that may have an impact on the processes depicted. In addition to what ISO describes as 'interested parties' - customers, vendors, suppliers, and stakeholders - it mandates that consideration be given to internal context (employees, regulations, and contractual commitments), external context (economic pressures, competition, and legal limits), and both at the same time. To ensure that the quality management process can accommodate all the parties and limiting variables that have any influence on quality results, this clause calls on the QMS to describe business activities in the broadest perspective possible.
Clause 5: Leadership
The duties of decision-makers and managers are outlined in this clause with regard to developing and carrying out the quality management system. It needs leaders to create a quality policy statement, allocate resources to meet quality goals, set objectives, and determine who is in charge of each component of the quality management process.
Clause 6: Planning
This provision encourages the use of risk management practises that don't limit opportunities and advises firms to pursue rewards while taking into account the risks involved. Additionally, it provides guidelines for formulating "quality objectives," which are intended to support the quality policy document's aims. In order to achieve these quality goals, the clause stresses the significance of allocating resources, delegating responsibility, establishing deadlines, and evaluating outcomes.
Clause 7: Support and Resources
Assuring that sufficient resources are offered to support the quality management process is the focus of this clause. To meet the quality management objectives, management must make sure that the necessary facilities, employees, equipment, and training are available. The clause also stresses how crucial it is to create efficient communication plans and channels.
Clause 8: Operations Control
One of the essential elements of the requirements for ISO 9001 certification is Clause 8. It stands for the 'Do' phase of the PDCA cycle and entails putting the plans created in the previous four clauses into action.
The clause places a lot of emphasis on the idea of "process control," which describes actions that guide ongoing processes towards the desired result (a high-quality final good or service). When third-party inputs have an impact on how your product or service is delivered, the clause mandates that preparations be taken to ensure the quality of both internal production processes and the services and goods offered by outside contractors and suppliers.
Clause 9: Performance Evaluation and internal audit
The 'check' phase of the PDCA cycle is represented by this clause, which mandates that organisations evaluate and compare process results to the defined quality targets. This requirement's goal is to evaluate how well the quality management system promotes ongoing improvement. Additionally, the paragraph mandates the use of internal audits to evaluate the QMS's capacity to meet both internal standards and the certification requirements outlined by ISO 9001.
Clause 10: Corrective Actions
Clause 10 asks that corrective action be done to address process non-conformities and inadequacies noted in performance evaluations, which corresponds to the 'act' component of the PDCA cycle. The effectiveness of these corrective measures should be determined by further analysis, which should try to address the root of the issue.
We hope that this article has given you a better understanding of the fundamentals of the ISO 9000 standards family as well as the procedures needed to create a Quality Management System that has received ISO 9001 certification. In our upcoming post, we'll look at some of the advantages that ISO 9001 certification may have for businesses and discuss how your IT system can help you achieve your quality management goals.
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