Well, you are not alone when faced with this problem. This general guide can help you understand why ISO 9001 Certification benefits your entire organization, find out what the requirements of ISO 9001 Certification are, as well as clarify the practical procedures to follow to become certified.
A clear introduction to the fundamentals of ISO 9001 Certification
ISO 9001 Certification is the international standard for Quality Management Systems (QMS), published by ISO (International Organization for Standardization). The standard, known as ISO 9001:2015, underwent its most recent upgrade in 2015. To become an accepted worldwide standard, ISO 9001 required the support of the majority of member nations before it could be published and revised and therefore accepted in the majority of countries in the world.
A survey on ISO 9001 certification at the end of 2017 shows that, despite the global recession. The number of companies that have implemented the ISO 9001 quality management standard remains stable worldwide.
Understand the true importance of ISO 9001
It is designed to be used by organizations of any size or industry, as well as any business. As an international standard, it is recognized as the basis for creating a system that ensures customer satisfaction and improvement in any company, and, therefore, many companies have it as a minimum requirement for their suppliers.
It is for this reason that ISO 9001 Certification has become a necessity for many companies to be competitive in the market. Additionally, your customers will be reassured that you have implemented a Quality Management System based on the seven quality management principles of ISO 9001 Certification.
ISO 9001 Certification is such a fundamental and influential standard that it is considered the basis when particular sectors wish to introduce specific requirements to create their industrial reference standards, as in the case of AS9100 for the aerospace industry, ISO 13485 for the medical devices, and IATF 16949 for automotive.
How is ISO 9001 made?
There are ten sections in the ISO 9001 structure. The first three are introductory, while the last seven contain the requirements relating to the Quality Management System. Below is a summary of the five main sections:
Organizational Context – This section talks about the requirements for understanding your organization to implement a QMS. It includes requirements to identify internal and external problems, identify stakeholders and their expectations, define the purpose of the QMS, and identify processes and how they interact.
Leadership – Leadership requirements address the need for senior management to be instrumental in implementing the QMS. Top Management must demonstrate commitment to the QMS by ensuring customer focus, defining and communicating the quality policy, and assigning roles and responsibilities within the organization.
Operation – Operational requirements cover all aspects of planning and creating the product or service. This section contains requirements related to planning, review of product requirements, design, control of external suppliers, creation and distribution of the product or service, and control of non-conforming process results.
Performance Evaluation – This section includes the requirements necessary to ensure that you can monitor the correct functioning of your QMS. These requirements include process monitoring and measurement, customer satisfaction assessment, internal audits, and management review of the QMS.
Improvement – This last section includes the requirements needed to improve your QMS over time. This includes the need to evaluate process nonconformities and take process-related corrective actions.
These sections are based on a PDCA (Plan-Do-Check-Act) cycle. Which uses these elements to implement change within the organization’s processes, to stimulate and maintain improvements within the processes.
Why is ISO 9001 an advantage for your organization?
It is impossible to overstate the benefits of ISO 9001:
companies large and small have used this standard to great effect, discovering and realizing incredible savings in terms of costs and efficiency.
Below, let’s look at some of those benefits:
Improve your image and credibility – When customers see that you are certified by an authoritative body, they understand that you have implemented a system focused on meeting customer requirements and improving.
Improve customer satisfaction – One of the key principles of the ISO 9001 QMS is to focus on improving customer satisfaction by identifying and satisfying their requirements and needs. By improving satisfaction, you increase customer loyalty.
Complete process integration – By using the process approach of ISO 9001. You not only take into account the individual processes in your organization but also the interactions of those processes.
Using fact-based decisions – Ensuring you make decisions based on real facts is a key to success for an ISO 9001 QMS. This way, you can better target resources to correct problems and improve your organizational efficiency and effectiveness.
Establish a culture of continuous improvement – With continuous improvement as the QMS’s major output. You may save more time, money, and resources while achieving ever-greater outcomes. By introducing this culture into your company. You can focus your workforce on improving the processes for which they are directly responsible.
Involve people – Who better than the people working within a process to find the most effective solutions to improve that process? By focusing your workforce’s efforts not only on maintaining. But also on improving processes, your staff will be more invested in the organization’s results.
What is ISO 9001 certification?
There are two types of certification:
The certification of a company’s Quality Management System against the requirements of ISO 9001 and the certification of individuals to be able to carry out checks against the requirements of ISO 9001. This section illustrates the phases of the procedure that a company must implement an ISO 9001 Quality Management System and have it certified.
ISO 9001 certification of your company involves the implementation of a QMS based on the requirements of ISO 9001; therefore, you will need to engage a recognized certification body to verify and approve your QMS as compliant with the requirements of ISO 9001.
Quality Management System
Starting from support in managing and identifying the customer’s requirements for the QMS. It will be necessary to start defining the quality policy and quality objectives. Which together define the overall purpose and implementation of the Quality Management System. Along with them, you will need to prepare the mandatory. As well as additional, processes and procedures your organization needs to build and deliver its product or service. Six mandatory documents must be present. While others can be added if the company deems it necessary. The preparation of these documents can be done internally. By your company, you can get help by hiring a consultant or purchasing documentation templates.
Once all processes and procedures are in place, you will need to use the QMS for a period. By doing so, you will be able to collect the records needed to move on to the next steps: verifying and reviewing your system and obtaining certification.
Mandatory steps to complete implementation and certify your company
After completing all your documentation and implementing it, your organization must also complete the following steps to achieve certification:
Internal audit – The internal audit serves to allow you to verify your QMS processes. Aiming to ensure that records are made. Confirming process compliance and identifying issues and weaknesses that would otherwise remain hidden.
Management review – An official review by management to evaluate significant data about management system processes to make appropriate decisions and allocate resources.
The business is split into two stages for the certification procedure:
Step one (documentation review) – Inspectors from your chosen certification body will verify that your documentation meets the requirements of ISO 9001.
Phase Two (Main Audit) – Here, the certification body inspectors will check that your operations are compliant with both ISO 9001 and your documentation by examining documents, records, and business practices.
What ISO 9001 training courses and certifications are there for people?
There are many training courses on ISO 9001 concepts, including a range of possibilities aimed at individuals, rather than companies. Among those that we will see below, only the first enables. The carrying out audits for a certification body. While the others can be very useful for those who intend to use this knowledge within their own company:
ISO 9001 Lead Auditor Course – This is a course lasting four or five days. Focused on understanding the ISO 9001 quality standard and the ability to use it for the audit of management systems concerning these requirements. The course includes a final exam to test knowledge and competence and only an accredited course can qualify a person to become an authorized auditor for a certification body.
ISO 9001 Internal Auditor Course – This is usually a two or three-day course. The content is based on the lead auditor course above. However it does not include a skills test, so is useful for those starting in audits internally within a company.
ISO 9001 Awareness and Implementation Course – Various courses provide an understanding of ISO 9001 and how to implement it. These can be one- or two-day courses, which can also include online distance learning sessions among the teaching methods. These courses are ideal for those needing an overview of ISO 9001 or those involved with its implementation. Within a company, many are cheaper than the costs of a lead auditor course for people involved at these levels.
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