In manufacturing conformance and compliance ensures quality in production and higher customer satisfaction. However, they differ in their manufacturing emphasis and the source of their standards.
Conformance is meeting internal quality standards within the company’s quality management system and fulfilling customers’ expectations. For example, the company specifications require a piece of an electronic to be a maximum of 200 grams. During production, quality control inspectors will ensure the conformance of the device’s weight to production standards.
compliance is adhering to external regulations set by governing bodies or industry standards. Companies that maintain regulatory standards such as EASA or ISO need to follow certain standards. Maintaining compliance ensures the passing of external audits and certification renewals.
For example, aviation or rail and transit industries have special regulations within their industry and might require a vendor certificate of compliance. Compliance certificate examples are ISO, EASA, or Security Management Act (FISMA)
Conformance and Compliance Overlap
Both conformance and compliance lead to higher product quality and thus higher customer satisfaction.
However, compliance and conformance often overlap. In other words, when a company complies with industry regulations (compliance), it often needs to adopt internal standards (conformance).
For example, maintaining certifications such as ISO or complying with specific contract obligations requires keeping both external requirements and implementing internal quality measures.
Conformance
Conformance is defined as the regulatory system that is followed within the internal quality management system. Each industry will have its own set of rules requiring a general certificate of conformity or a certificate of conformance.
In quality control, Conformance could include:
- Product specification: Products or processes are compared against a standard, specification, or customer requirements to ensure production consistency
- Continuous Improvement: Internal conformance could include implementing continuous improvement and improving production standards.
Compliance
Compliance is concerned with the external rules and regulations. These external regulations could be non-negotiable laws or federal or state regulatory requirements. They could also be specific customer requirements as part of the contractual agreements. Contractual agreements include the contract terms that are agreed upon with the customer and the company is legally obliged to comply with the terms.
In summary, in quality control, compliance often includes:
- Regulatory Standards: State of federal laws, and industry regulations with legal requirements in place.
- Certification Requirements: These could be requirements needed for obtaining certifications (such as ISO) or meeting specific industry standards. They are needed to comply with external audits and re-newing Certification.
- Contact Obligations: Regulated industries often need to adhere to certain quality and standards, so they need their vendors to adhere to certain contract obligations. If such requirements are mandated in the contract fulfilling them is a compliance.
Compliance and Legal Risks
Failure to comply with legal standards could mean penalties, fines, or regulatory sanctions for a non-compliant organization. So, businesses need to identify and address compliance gaps to mitigate such risks proactively.
Assessment and Certification
Companies might require their vendors to provide a Certificate of Compliance to ensure the safety and regulatory compliance of their products. This is to make sure that the components used in their products meet their required standards.
Conformity Assessment and Certification
On the ISO website Certification is defined as: “Certification is the provision by an independent body of written assurance (a certificate) that the product, process, service, or system in question meets specific requirements.”
This process is to show your conformity to requirements.
Certifications: Conformance vs Compliance
Certification paves the road for entering the market and being part of the game. While CoC provides liability for the actual transaction between buyer and seller. Below generic examples below should provide a better sense of the difference between conformance and compliance.
- To check the credibility of a company you ask to see if they have any certification.
- To show off your credibility, you affix your certifications and awards in the lobby or on your website.
- When buying a product or service, you request a CoC to receive a warranty or detailed specification of such a specific item.
- When selling a product or service, you issue a CoC to provide a warranty or detailed specification for a such specific item.
Certifications and Awards that you have received from different organizations will show how well you are recognized by others. Yet the customer needs a CoC for the actual product that he is buying. For example, regardless of the manufacturer’s reputation, you need a CoC for the car that you are buying, indicating the serial number and terms of the warranty.
The request for CoC is a common practice for Maintenance, Repair and Overhaul Services.
Conformance, Compliance, In-process Inspection
In-process inspection is a critical part of a quality management system. In-process inspection ensures compliance in both conformance and compliance.
When it comes to conformance, in-process inspection helps with the verification of products or services against industry standards. Since it allows for inspection at various stages of production.
When it comes to compliance, in-process inspection contributes to compliance efforts by verifying compliance with external regulations, laws, or contractual obligations.
By inspecting processes and outputs against regulatory requirements, your company can identify and address potential non-compliance issues early. This helps your company mitigate legal risks, regulatory fines, or reputational damage. Overall, in-process inspection has an important role in promoting conformance to internal quality standards. And compliance with external regulations. thereby enhancing the overall effectiveness and integrity of the quality management system.
Summary Table: Conformance vs Compliance
Here is a summary of the Conformance vs Compliance
| Aspect | Conformance (Internal Quality Control) | Compliance (External Regulations) |
|---|---|---|
| Definition | Meeting internal quality specifications and customer expectations. | following external regulations, standards, or contractual obligations. |
| Manufacturing and quality objective | Fulfilling internal quality control standards and customer needs. | Meeting external requirements set by regulatory bodies or industry authorities. |
| Standard | Internally determined based on organizational goals and customer preferences. | Externally mandated by regulatory bodies or industry standards organizations. |
| Quality goal | Upholding product quality, enhancing customer satisfaction, and maintaining brand reputation. | Ensuring legal and regulatory adherence, mitigating risks, and facilitating market access. |
| Examples | Verifying product quality after production. Doing quality assurance checks to ensure production meets internal quality requirements | Obtaining certifications, meeting safety standards, and complying with legal regulations. |
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