Frustrated with ISO Certification Process?
ISO 9001 Certification - How to get ISO Certification?
ISO 9001 certification is a powerful indicator of a company's adherence to the ISO 9001 standard, which outlines the requirements for a robust quality management system. ISO certification generally refers to compliance with any ISO standard; ISO 9001 certification specifically demonstrates a company's commitment to providing quality products or services that meet or exceed customer expectations. Obtaining ISO 9001 certification can give a business an advantage in the marketplace and help establish a reputation for excellence in quality management.
It is a common misconception that ISO certificates are issued and certified by International Organization for Standardization. International Organization for Standardization (ISO) does not provide audits or certification. Also, International Organization for Standardization (ISO) will not issue an ISO certificate. ISO merely sets out the standard for the quality management system. Organizations, large or small, or any industry, manufacturing, trading, or service, can use these standards to improve their operations.
ISO certification is a vital tool that can help organizations demonstrate their commitment to quality management and customer satisfaction. ISO recommends performing internal audits to confirm the competence of the quality management system implemented. Conducting regular internal audits and obtaining an independent third-party certification can strengthen the quality management system's effectiveness and validate the organization's credibility. Many certification bodies (Registrar), accredited and non-accredited, provide certification services and issue ISO 9001 Certificates. Accreditation is not mandatory, and a certificate from a non-accredited certification body does not mean it is invalid. The credibility and reputation of the certificate depend on the certifying body's reputation and expertise. An independent third-party audit and certification will help confirm the competence, enhance your organization's credibility, and increase its competitive edge.
LMG offers ISO 9001 and ISO 13485 Certification assistance to Chicago and suburbs from Aurora, Illinois, and New York & surrounding states from New York. We provide complete assistance from ISO documentation through certificate issuance. Our experienced consultants can help you to find the right ISO certification body that fits your needs and get an affordable ISO certification in the shortest possible time frame.
Benefits of ISO 9001 Certification
- Increase the Credibility of your Organization.
- Improve the Quality of Products and Services.
- Enhance Business Performance.
- Demonstrate Commitment to High-Quality.
- Enhance Customer Satisfaction.
- Achieve International Quality Recognition.
- Increase Effectiveness and Efficiency.
- Better Coordination.
- Enhanced Repeat Business.
- Optimized Performance.
- Improved Decision-making.
What does ISO 9001:2015 stand for?
ISO 9001:2015 consists of two parts ISO 9001 and 2015. ISO 9001 is a standard in ISO 9000 family and is the only certifiable standard in ISO 9000 series. 2015 is the version or the year the ISO 9001 standard was published, the current version of the ISO 9001 standard is ISO 9001:2015, published in 2015-09 edition 5.
How to get ISO 9001 Certification?
Getting ISO certification is a long process; it may take three to four months to get the ISO 9001 certification. The core of ISO certification is continual improvement; the quality system will be more and more perfect every year. It may take a couple of years to develop an excellent quality system. Below are the significant steps in ISO certification process.
Key Steps in ISO 9001 Certification
- Identify the Requirements
- Define the Scope of Certification
- Define the Process and Procedures
- Select the Certification Body
- Implement Processes and Procedures
- Training and Awareness
- Internal Audits
- Management Review
- Corrective and Preventive Action
- Stage 1 Audit
- Certification Audit
- Closing NC'S
- Award ISO Certificate
- Surveillance Audit
Our ISO Certification assistance includes.
ISO 9001 Certification
Small business ISO 9001 Certification
ISO 9001 Certification is challenging for small businesses because of the minimal resources available, the cost of iso certification, and the difficulty in interpreting ISO terms like the context of the organization, risk-based thinking, evidence-based decision-making, control of externally provided processes, needs and expectations of interested parties, etc.
Proper implementation of the right quality standards will help a small business to improve its overall performance and provide quality products consistently. ISO 9001, suitable for all organizations, is the most used quality system standard by small businesses.
ISO 9001 Certification is inevitable for small businesses due to customer requirements. The ISO 9001 certificate shows that the company has implemented a quality system and can provide the products and services with a minimum required or better quality.
Getting assistance from an experienced ISO 9001 consultant will help small businesses to save certification time and cost and free up top management (which is crucial for small businesses with one or two top management personnel) from day-to-day involvement in the ISO certification process.
ISO Certification - Frequently Asked Questions
ISO certification is the process of getting certified by an ISO certification body. The ISO certificate is evidence that you implemented a quality system and company/process is complying with relevant ISO standards.
Vendor approval/evaluation is part of ISO implementation; getting products and services from an iso certified company may be a clause in your customer’s purchasing procedure, which will help them to avoid an expensive onsite audit.
ISO - International Organization for Standardization - is located in Geneva, Switzerland. ISO is an independent, non-governmental international organization with a membership of 167 national standards bodies, including ANSI (American National Standards Institute). There are a lot of American certification bodies, accredited and non-accredited. You can find a list of accredited American certification bodies at ISO CERTIFICATION BODY
ISO develops different standards for different scopes. If you are looking for a general management system certification, ISO 9001 is recommended. ISO 13485 is the best option for medical device companies developed specifically for medical device establishments. If you want to improve your environmental performance, you can use ISO 14001. Similarly, ISO sets industry-specific standards; please find the different standards and their applicability at ISO Standards
It depends on the scope of certification; for ISO 9001 Certification, you can go with certification for the company or some process. Suppose you are a manufacturing company with a process design and don’t want to add it to the certification scope. You are free to do so.
The certification body issues an ISO certificate for three years assures that the management system is in place and is working well as long as the certificate is valid; to keep the assurance, the certification body needs to conduct surveillance audits at least once a year.
The duration may change with factors like scope, number of employees, number of products, departments, etc. The certification body selected also plays a vital role in certification time. Some certification bodies accept the “readiness” if you are new to ISO certification, but some certification bodies need to see the evidence for 1-2 years.
Reducing costs is one of the primary objectives for small businesses. Good planning is essential for this. Also, at least one ISO expert must be available during the certification process. If you do not have an ISO expert in your facility, it is advisable to get help from an external ISO Consultant. Since there are several certification bodies available, you need to schedule the audit only after an internal audit, which will help assess the quality system's strengths and weaknesses.
For small companies, it is always better to hire an ISO consultant unless they have an ISO expert. It may be a financial hurdle for small companies to keep an ISO expert year around. ISO Certification for Small Companies
LMG provide complete assistance from documentation through certification. Our experienced consultants can help you to
- Define the scope of certification
- Identify the requirements
- Prepare quality manual
- Prepare quality system procedures
- ISO implementation
- Internal audit
- Certification body selection
- Certification body audit
- Closing certification body NC’s
Yes, we will help you find a certification body that best fits your establishment and coordinate with the certification body.
Minor NCs and observations are usual on ISO certification body audit; this will not affect the certification process; we will help you to raise CAPA and close the NCs. In the case of major NC, the certification body will issue the certificate only after closing the NC.
Your customers can verify the certificate’s authenticity on the certification body’s website or write to the certification body.
Sure, if all ISO certificates are from the same certification body, you can request a combined audit.
Does US FDA accept the ISO 13485 certificate? Can I use an ISO certificate instead of an FDA registration?
US FDA is a federal government agency that will not accept third-party certificates. FDA registration is a mandatory requirement for food, drug, and medical device companies. ISO certificate cannot use in place of FDA registration.
Documents Required for ISO Certification
Below are commonly asked-for documents and records during an ISO Certification audit. The ISO auditor will verify the documents and records to confirm that the company has all the required procedures as per ISO standards and is following them.
ISO 9001 Certification Audit Process
Organizations facing the first ISO 9001 certification audits are anxious to know what precisely an iso auditor does in the audit process. The ISO defines an audit as a “systematic, independent, and documented process for obtaining objective evidence and evaluating it.” The ISO auditor verifies whether your company has a quality system that complies with the corresponding ISO standard and how well you implemented it.
The auditor assesses the level of implementation by verifying the documents and records and by a facility tour or physical inspection. Most ISO audits are specimen audits; the auditor starts from the finished product or the raw material and verifies the traceability. The auditor’s questions are based on the records the auditor reviews in the facility or the process the auditor witnessed during the facility tour. Even though you have all the mandatory procedures and records, it may result in NC or observations if you cannot provide proper justification for auditor questions. An experienced consultant can help you to answer the auditor’s inquiries and close any NCs immediately.
Our Services includes.
- ISO 9001 Consulting
- ISO 13485 Certification
- ISO 20000 Certification
- ISO 22000 Certification
- ISO 27000 Certification
- GMP Certification
- US FDA Certification
- CE Certification
- 21 CFR 820 Consulting
- 21 CFR 211 Consulting
- 510 K Consulting
- FDA DMF Consulting
- FDA Drug Consulting
- FDA Cosmetics Certification
- FDA Medical Device Registration
For more information, Please contact us with detailed information.
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- ISO 9001 Consultant - Chicago
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- ISO 9001 Certification vs Implementation
- ISO certification cost for small business
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- Transport industry ISO 9001 Certification
- ISO 13485 Certification
- ISO Certification - FAQ
- 51 Most Popular ISO 9001 Certification Pages
- US FDA Certification
- 21 CFR 820
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Why Choose LMG for ISO Certification?
We help all quality systems, including ISO Certification, US FDA GMP, and CE Marking. Our expertise in all these quality systems will help our customers make an integrated quality system if they need a single quality system for multiple standards or transition to another quality system in the future.
LMG has been assisting customers since 2009; LMG was started to help companies with US FDA regulations and extend its services to ISO certification and European quality systems regulations.
LMG has the lowest fees in the industry, and we provide the total cost of ISO certification before starting the project; there are no hidden fees so that the customer can plan the budget accordingly.
In most cases, we provide a free onsite ISO consultation to help the customer to decide on the certification type, select the certification body and scope of certification and provide a cost estimate.
Our ultimate aim is to get an ISO certificate for our customers; we always focus on the results. We assess the level of implementation before selecting the ISO Certification body and help the customers to choose the appropriate certification body.
Our ISO consultants are friendly and ready to listen; we make tailor-fit quality system solutions for your company.
We will provide you with an estimate of the completion time for ISO Certification before we start the project. Faster certification is essential for most small business iso certifications.
Our long-time service history helps us select the right certification body that fits your company and requirements.
LMG helps our customers, from certification body selection to issuing the ISO certificate.
LMG started in 2009 in Aurora, Illinois, USA, and has offices and associates worldwide. Unlike online consultants, Our offices in the USA help us become easily reachable.
Most Popular ISO Certifications
Scope of standard
ISO 9001 Certification
General Quality management systems
ISO 13485 Certification
ISO 22163 Certification
ISO 29001 Certification
ISO 27001 Certification
ISO 14001 Certification
ISO 45001 Certification
Occupational health, safety
ISO 50001 Certification
ISO 22000 Certification
Food safety management
ISO 17025 Accreditation
Testing and calibration