Understanding Quality Certifications for Injection Molders
Plastics Manufacturing Resources, a FORGE partner, connects companies to a wide range of plastics manufacturing options, from injection and blow molding to additive manufacturing, thermoforming and more. In this Tools of the Trade, they explain quality management systems and certifications for plastics manufacturing. These are the quality certifications for injection molders you should know!
Quality Management Systems (QMS) and Certifications should be an important part of your vendor selection process when comparing injection molders and custom manufacturers. Let’s take a look at ISO 9001 and some of the more common Advanced Quality Certifications (AQC) as a framework to help you through your decision-making process.
ISO 9001 Certification
Think of ISO 9001 as the baseline Quality Management System (QMS). It can be applied to multiple industries, not just manufacturing. Therefore, it is more of a generic certification and offers flexibility to interpret the requirements for almost any business. This does not mean that it is not effective, because it is.
Advanced Quality Certifications
Vendors may also have additional certifications including ISO 13485; AS9100 and IATF 16949. These certifications are referred to as Advanced Quality Certifications. All of these are built on ISO9001 but they incorporate additional requirements that are specific to a certain industry.
- AS9100 = Aerospace/Defense Industry
- ISO13485 = Medical Device Industry
- IATF 16949 = Automotive Industry
AS9100
For example, in the AS9100 standard, there are provisions for “Product Safety and Counterfeit Parts”. That requirement doesn’t exist in the other QMS. This requirement was driven by the discovery that the Military found counterfeit electronic processors installed on the Blackhawk Helicopter. Because of the safety implications, the industry added safeguards directly into the standard.
ISO 13485
For medical device companies, ISO 13485 has provisions for significant documentation. Medical devices have the added demand for patient safety. Medical Device companies are required to maintain a Device Master Record (DMR) and they rely on their manufacturer to keep accurate records that will be part of the DMR.
IATF 16949
The automotive industry (IATF 16949) strongly emphasizes defect prevention and waste reduction within the supply chain. It is important to remember that a production line down on an automotive line is catastrophic so prevention is the key.
What All Standards Have in Common
While there are specific requirements based on industries there are some items that are contained in all of the standards. All versions of the current standards are centered on “risk based thinking” and “aligning the QMS with organizational policies and objectives”. For example, the company is tasked with looking at regulation risk and how it can affect the business. Keystone Pipeline is a good example. Leaders at TC Energy Corporation would be required to identify regulatory risks that could shut production down. In 2016 that came true. It also includes technological threats and risk mitigation. Examples include VHS movie cassettes, landline phones, maps, typewriters, and the Polaroid camera.
Which Standard do I need?
So what QMS standard should you be looking for when it comes to your particular project? If your company doesn’t have a requirement for a particular standard, that leaves you open to more options. Working with a company that has an Advanced Quality Certification certainly won’t hurt the product. In fact, it could be of great benefit as the AQC may have tighter requirements in terms of validation and process control. However, keep in mind that with Advanced Quality Certificates usually come larger operating overheads which can influence the price you will pay. A molder with ISO 13485 may be 5%-15% higher than a molder with ISO 9001. Run a cost vs benefit analysis to help you choose.
Here is a helpful guide for comparing these standards against each other. This link is to Intertek which provides polymer testing, polymer formulation consulting, compounding, failure analysis & other polymer services. Click here to learn more.
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