Every company owner needs a certified manufacturer who delivers quality. Choosing the right one can be challenging at times due to multiple factors, such as verifying certifications, aligning with your product’s needs, or assessing actual quality.
That’s why you have to ensure that your manufacturer is a reliable supplier, certified, and efficient. With the perfect partnership, you can reduce risks and increase the quality of your products. You want to know if yours is trustworthy? This is how.
The difference between having a certificate and living up to the standard
Having a certified manufacturer is essential for maintaining high standards and reliability. Especially if they are in charge of the production process for your company. A credential indicates that the individual is capable of meeting the goal.
However, a certification is no guarantee of meeting the standard or ensuring a truly excellent production process, nor of fulfilling the company’s needs. Besides the credentials, the manufacturer must be professional and deliver high-standard service.
Living up to the standard is more than just having a formal document that qualifies the supplier to do the work. A manufacturer must achieve daily execution through:
- Day-to-day monitoring
- Constant improvement
- Problem-solving
- Connecting the production processes with the real company needs
These indicators will transform production management into measurable and clear daily goals, establish tracking indicators for quality, and minimize nonconformities.
Red flags that may indicate a quality system is superficial
Red flags can help your company identify when a manufacturer is not capable of providing quality production systems. This means that their production process lacks communication, high-quality standards, transparency, and efficiency.
These are some of the red flags that may help you identify that the quality system is not reliable.
No batch control
This means that the manufacturer is unable to track the entire production process.
So, they can’t identify or trace product defects. This may imply widespread quality problems. Therefore, recall management can be a complex process.
Informal documentation
Every manufacturer must keep up-to-date documentation concerning processes, production, and quality control records.
The lack of this information documentation is a clear sign of a disorganized system. This can be attributed to a lack of evidence to ensure quality and audits for supplier evaluations.
No change control
When there’s no formal process that guarantees changes to projects, systems, products, or methods, the manufacturing cannot be evaluated, approved, and verified.
Keeping records throughout is necessary to ensure change control in the manufacturing process. Otherwise, the manufacturer won’t be able to make changes without knowing if the process or product will be negatively impacted.
That will put the process in danger and compromise the product compliance and the ISO traceability.
Other red flag indicators include an unwillingness to provide references or a lack of transparency regarding financial matters. All of these will undoubtedly result in quality inconsistencies, delivery delays, traceability deficiencies, and more.
How to verify that a manufacturer practices what they preach
Certified manufacturers practice what they preach when they act in accordance with their words. There are actions that you can observe to ensure and verify the company’s operations.
Some of these include leadership behavior and company culture, documentation and process examination, process performance, and final product supervision.
- A leader committed to the business is someone who consistently aligns with the company’s high standards and values.
- The declared culture of the corporation must be shown in every aspect of the organization. Ensure that each department actively embodies the company’s values through its daily operations and activities.
- Search for employees’ feedback to determine if the company’s operations meet the stated intentions. This can be verified through surveys or direct interactions with them.
- Request and deliver test reports and certificates of documentation to validate quality and regulation compliance.
- Comprehend the manufacturing processes to determine if production is improving constantly or just meeting basic requirements.
- Confirm if the human resources are being hired, trained, and disciplined by the preached values of the company.
- Test samples to verify if the product aligns with your company’s needs and with the quality standards of the manufacturer.
- See if the production process is filled with transparency and meets the goal they preach.
- Involve third-party organizations that can ensure the validation of a high-quality production process.
Most importantly, look for ISO traceability, which will facilitate problem resolution, ensure quality, mitigate risks, and promote compliance and recalls.
Certification Bodies vs. Manufacturer Claims: What to Check
False claims and counterfeit certificates are much more common. Therefore, you must validate certificates through the competent authorities. To do this, visit the certification official website and verify if a trustworthy third-party body issues it.
This process is crucial when claims have been submitted, and you need to verify their legitimacy. You can, specifically, check this information to be sure that your certified manufacturer is meeting the standards:
| Certification Bodies | Manufacturer Claims |
| – Check a reputable certification body with national accreditation. | – Request copies of the certifications and verify their validity on the official websites, such as those of ISO. |
| – The body must follow appropriate standards that meet relevant guidelines for certification bodies. | – The standards for quality management systems and claims have to be aligned with the certification. |
| – Reputation and accreditation are both needed to ensure that the certification body has the competence and impartiality required. | – Confirmation through independent certification bodies is more relevant than the manufacturer’s claims. |
| – The accredited bodies that can fulfil the task of verifying certification’s authenticity have official web pages. There, you can confirm and verify certifications and accreditation claims. | – Counterfeit certificates are as standard as any other form of documentation. That’s why they must be verified officially through the issuing certification body. |
RexMed’s Commitment to Operationalizing Its ISO 13485 Certification
The production process involves several areas that influence the Quality Manual System (QMS). The certification enables verification of reliability and effectiveness through audits in the work area, involving experts.
This process enables the detailed evaluation of every scenario involved in production, including development, design, customer care, and any other practical factor, during the production process of your certified manufacturer.
ISO 13485 Certification: Daily process execution
There are four steps when it comes to the certification process:
1. Preliminary audit. This is optional and includes a voluntary visit to the site. The purpose is to evaluate the quality management documentation and other matters to measure readiness for Stage I and II audits.
2. Stage I. What is the ISO 13485 audit itself? This step evaluates the certification’s eligibility based on the analysis, results, and business assessment of the quality management documentation.
3. Stage II. The second part of the ISO 13485 audit. This step involves checking the quality management system, which is conducted on-site to ensure efficiency and proper practice during production.
4. Certification. Finally, you receive an official confirmation once you meet the requirements. This is the certificate that verifies or confirms that the quality management system and complete compliance fulfill integrity standards
ISO certifications or any other quality certification bodies are not a legal requirement for operating as a manufacturer. However, your business, like everyone else’s, is more confident as a client and consumer knowing that their manufacturer or supplier is certified.
Your company gains numerous benefits when a certified manufacturer delivers quality, efficiency, and transparency throughout the production process of your products. As for reducing risks and improving delivery times for your final products.
