What is ISO 9001 Certification (QUALITY MANAGEMENT SYSTEMS)?
ISO 9001 Certification is a set of standards published by ISO (the International Organization for Standardization). Its purpose is to enable the organization in implementing the Quality Management Systems (QMS). The standard was last upgraded in 2015; hence it is referred as ISO 9001:2015 Certification. ISO 9001 is agreed-upon by a majority of member nations, making it a universally accepted Standard.
Who should use the ISO 9001:2015 Certification?
ISO 9001 Certification is suitable for any type of organization, regardless of scale or sector. More than one million organizations from more than 165 countries have applied for the ISO 9001:2015 standard requirements into their QMS.
Using the ISO 9001:2015 Certification Supports the organizations in the following ways:
- Organize measures
- Continual improvement
- Improve the effectiveness of PDCA cycle
What topics do ISO 9001:2015 Certification cover?
ISO 9001 Certification (QMS) is based on the plan-do-check-act (PDCA)methodology and gives a cycle-oriented way to deal with archiving and looking into the structure, duties/responsibilities, and strategies needed to accomplish successful quality management in an association. Explicit segments of the standard contain data on numerous themes. For example,
Requirements for a quality management system, including documented-information, arranging and determining process interactions.
Responsibilities of the management.
Management of assets, including human resources (HR) and workplace conditions.
Product acknowledgment, including planning and conveying to the employees at every level.
Measurement, investigation, and improvement of the QMS through exercises like internal-audits and structuring preventive and remedial activities.
What is the advantages of ISO 9001 Certification?
ISO 9001 Certification aims to deliver a practical and functional Quality Management System for improving and observing your business holistically.
Some of the main advantages of ISO 9001 certification include:
Suitable for both small and large association.
Improved customer satisfaction.
Consistent outcomes though measurement & monitoring.
Internationally recognized ISO standard.
Provides best methodology for internal management.
Helps in reducing wastage.
Helps in increasing efficiency, productivity & profit.
Compatibility with other ISO standards.
ISO 9001 certification maps-out the significance of high-quality goods and services. Also, in the highly competitive market rate the organizations struggle being differentiated. Hereby ISO 9001:2015 Certification is an eminent tool for sustaining and nurturing in the market.
Certify your organization to revamp your functioning system. The ISO 9001 certification aids to structure and align your business credibility and authority resulting into overall efficiency of the business.
We at SIS Certifications look forward to support you in all the possible ways. We are always happy to support you, Starting from the Guidance to understand and choose the relevant standard for your organization till getting certified. Our world class experts and our executive sales team would love to contact you anytime.
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Management system standards such as ISO 9001 is one of the Standard which is also know as the mother of all standards needs to be understood. We at SIS Certifications are well equipped with the experts and trainers who can train you and get you to another level of understanding of the requirements of the standard.
There are various types of ISO 9001 training which you can undergo based on your requirement of level of understanding and need of the standard.
The training can be categorized in to Awareness training, Internal auditor training, lead auditor training and Implementation training.
What is ISO 9001 Certification?
ISO 9001 is the most recognized standard in the world.
ISO 9001 Certification aims to meet the expectations and requirements of the clients and stakeholders more effectively. It is done by building a framework that would ensure a consistent quality of good and/or services to the customers.
What is the quality management system (QMS)?
The standards present in ISO 9001 Certification helps in designing or improving the QMS for a company by enabling it to create all the policies, processes, and procedures necessary to produce goods and services that meet the requirements of customers and regulatory bodies. Quality management systems are the foundation of quality assurance.
Quality is not an act, it’s a habit
ISO 9001 Certification is one of the most recognized international standard strengthening Quality Management System of the organization. The standard accommodates the organizations with set of statutory, regulatory and quality related norms to meet changing expectations of customers and the interested parties. The set principles and approaches by ISO 9001 Certification , empowers consistency in the organizations around the globe which inculcates effectiveness in their quality management system.
Why is ISO 9001 Certification important?
As stated above, ISO 9001:2015 Certification is an internationally recognized standard for creating, implementing, and maintaining a Quality Management System for a company.
Enhances customer satisfaction.
Many organizations require ISO 9001 certification from their suppliers too.
It can be used by an organization as a reference to create quality management system of their own. For example, ISO 13485 Certification for medical devices industry, AS9100 for aerospace industry, and IATF 16949 for the automotive industry.
A recent study showed that in spite of global recession, companies that had ISO 9001 certification did not get affected.
What does the current ISO 9001 standard include?
ISO 9001:2015 Certification is the latest revision in ISO 9001 Certification. It was released in 2015. The new version focusses on risk assessment and understanding the “context of the organization”. There are major differences between the 2008 version and the 2015 version in terms of major clauses of the standard.
History of ISO 9001 Certification -
ISO 9001:2008 is the old version of ISO 9001 that was withdrawn in 2015.
ISO 9001:2008 Certification has been replaced by ISO 9001:2015 Certification, with some minor additions.
Now, what exactly is ISO 9001:2000 Certification?
ISO 9001:2000 Certification was the first revision of the ISO 9001 standard to be based on the seven quality management principles. It laid down the requirements for maintaining quality products and services. Earlier revisions of ISO 9001 (ISO 9001:1987 & ISO 9001 1994) were based more on writing and following 20 specific procedures, rather than understanding the context and processes of the organization.
How is ISO 9001 Certification Structured?
The High-Level Structure (HLS) is a set of 10 clauses that all ISO management system standards are required to use in the future. This is so that all management system standards will have the same look and feel, and will enable greater integration between systems of different disciplines. These are called clauses. The first three are introductory, while the last seven contain the requirements for the Quality Management System against which a company can be certified. Let us understand in detail about these Seven clauses.
Clause 4: Context of the organization – It refers to understanding the organization’s requirements for implementing QMS. It includes understanding the internal and external issues and the requirements accordingly, identifying the interested parties and their expectations, defining the scope of the QMS, analyzing your current processes and the interaction between them. Legal and regulatory requirements are covered under “expectations of interested parties”.
Clause 5: Leadership – The leadership requirements cover the need for top management to be instrumental in the implementation of the QMS. Top management should ensure customer focus, assignment of roles and responsibilities throughout the organization, and communicate the policies with the entire workforce.
Clause 6: Planning – The onus of planning out an effective QMS lies with the Top management. With the assessment of risks and opportunities of the QMS, quality objectives can be designed for improvement and effective planning can be done to accomplish these objectives.
Clause 7: Support – It deals with management of resources for QMS, including infrastructural resources, human resources, the working environment, monitoring and measurement resources, and the knowledge about the organization. This section also includes requirements around competence, awareness, communication, and controlling documented information (the documents and records required for your processes).
Clause 8: Operation – All the aspects of planning and creation of products and services are dealt under the section of operation. It includes planning, reviewing the requirements of the product, its design, controlling external providers, creating and releasing the product or service, and controlling nonconforming process outputs.
Clause 9: Performance evaluation – This section includes the requirements that would ensure if your current processes of QMS are effective. It includes the method of monitoring and measurement, assessing customer satisfaction, internal audits, and reviewing the management of QMS constantly.
Clause 10: Improvement – This section includes the guidelines and requirements for making your QMS better over time. This includes the need for assessment of process non-conformity and taking corrective actions for the processes.
These sections are based on the management principle of Plan-Do-Check-Act cycle. By using these elements, changes can be implemented within the organization, and processes can be improved from time to time.
What is a quality management system?
The Quality Management System, which is often referred to as QMS, is a collection of policies, processes, documented procedures, and records.
The documentation defines rules for company to deliver standard product and services to the customers.
A QMS should be tailor-made according to the requirements of your organization. ISO 9001 Certification acts as a reference for creating a world-class QMS for your organization.
How is ISO 9001 Certification Implemented?
Your organization needs to define quality policy and quality objectives on the basis of the requirements of your organization. It requires the support from the management and understanding the customer requirements. These will define the scope of your QMS. In addition, you will need to create some mandatory processes necessary for your organization to create and deliver quality goods and services. There are six mandatory documents for implementation of QMS. Other documents can also be added as per the requirements of the organization.
Once all the processes are in place, the QMS should be operated for a period of time. This is necessary to collect records for proceeding towards next steps, i.e., auditing and reviewing your system for the purpose of certification.
How much does it cost to get ISO 9001 certification?
The cost of ISO 9001 certification varies from organization to organization. The requirements of different organizations are different; for example, some include the design and development process and some don’t, the amount of efforts required for the implementation of the process and the cost associated with it also varies. Depending upon the complexity of your processes, the cost of auditors for the certification also varies. Some of the major areas that render costs are, learning about ISO 9001 , external help, cost of employee’s time, cost of certification, and the cost of maintaining your QMS.
Since, cost of the certification is a major expenditure, contacting several certification bodies to obtain the best quote is advisable. The certification body may also provide assistance in identifying the requirements that are not yet met and gaps in the system. The cost of implementation of QMS can be identified on the basis of gap analysis and modification of the system on its basis.
Steps for a company to get ISO 9001 certified-
For your organization’s QMS to be certified, you are required to complete its implementation. Once the documentation is complete, and the process is implemented, the following steps should be performed by your organization for a successful certification:
Gap Analysis – Auditor/Expert visited work place to review and document our current-processes & procedures, then highlighted any areas that did not meet the requirements of the ISO 9001 standard.
Training – A gap analysis is a review of existing documentation and management processes to help you assess how much work is needed to get you up to scratch with your ISO standard, as well as help you plan your project.
Document Support – Any-changes needed to existing-processes & procedures were made.
Implementation – An auditor/Expert visits work place on an annual-basis to check that all of the documented-processes are being following & once they are satisfied a New ISO certificate is issued
Internal audit – Here, the records are checked for their compliance with the requirements of ISO 9001 Certification. The weaknesses in the system is identified and corrected at this stage.
Management review – At this stage, a formal review by the management is done to check the effectiveness of the processes, and make appropriate decisions by assigning resources.
Corrective actions – After the internal audit and management review, the root cause of the problem is identified and corrective actions are taken. These actions are needed to be documented.
The certification process can be divided into two stages:
Stage One (documentation review) – The auditors from the certification body that you have chosen will review your documentation to ensure whether they meet the requirements of ISO 9001.
Stage Two (main audit) – Here, the auditors of the certification body of your choice will verify whether your actual activities are compliant with both ISO 9001 standards and your own documentation by reviewing documents, records and company practices.
Key benefits of ISO 9001:2015 Certification -
Improved customer satisfaction
Higher operating efficiency
Better employee engagement
Better process integration
A continual improvement culture
Better supplier relationships
Principles of ISO 9001 Certification :
Roadmap to accomplish ISO 9001 Standard:
The initial assessment determines if the mandatory documentations as per the requirements of the ISO 9001 standard are being met and if quality management system is capable of proceeding to Stage 2.
The second stage determines the effectiveness of the system as per the requirement of ISO 9001 and seeks to confirm that the management system is implemented and operational.
Recommendation for Certification
At this specific stage, review is conducted for corrective actions taken to examine the findings from Stage 1 and 2 and further recommended by the auditors for ISO 9001 Certification.
Certification review and Decision
The impartial panel reviews the organization’s files and decision for the issuance of ISO 9001 Certification to the organization is taken.
Issuance of Certification
Successfully ISO 9001 certification is achieved and the certificate is issued to the client.
As per the requirements of ISO/IEC 17011, ISO/IEC 17021, the organization has to go through the regular surveillance audits for the continuation of the certifications. ISO 9001 Surveillance audits normally takes place yearly, ie; 2 surveillance audits in one certification cycle of 3 years.