Certification of ISO standards by the International Organization of Standardization (ISO) have become a major expectation in modern manufacturing and allow contract manufacturers to provide proof of adherence for their quality management systems (QMS). Below are a few of the most important ISO certifications which are commonly requested in PCBA manufacturing.
ISO 9001- General
First Published in 1987, the ISO 9001 requirements are the basics of an effective QMS. This approval covers essential quality management, and is seen as the standard requirement for manufacturing and service oriented organizations. The ISO 9001 consists of a series of basic standards that must be implemented in your particular organization based on how the company runs its business.
As of 2021, over 1.1 million ISO 9001 certificates are current across over 170 different countries making it the most widely recognized ISO approval. Certification involves a two phase auditing process and a reevaluation process every three years in which the manufacturer must display ‘continual improvement’ in their QMS.
ISO 13485- Medical
ISO 13485 covers quality management systems within the manufacturing of medical hardware. It is important to note that the ISO 13485 is an independent standard that is closely related to ISO 9001, but includes some regulations for medical devices & excludes some irrelevant regulations.
The ISO 13485 includes a strong focus on risk management activities during product development, strict inspection and traceability requirements for implantable devices, as well as documentation and validation processes for sterile medical devices. It has special requirements relating to In-Vitro diagnostics and for verifying effectiveness in corrective or preventive actions made during manufacturing.
Certification requires a lengthy 2 stage assessment process, as well as basic inspection every six-months to a year and full reassessment every three years. Unlike the ISO 9001, the ISO 13485 doesn’t require proof of continued improvement during reassessment, and instead requires that the certified organization demonstrate that the quality management system is effectively implemented and maintained.
AS 9100- Aerospace
The Aerospace Basic Quality System standard or AS9100, is a widely used standard required by major aerospace manufacturers. This ISO standard was created by a committee of avionics contractors from companies such as Allied-Signal, Allison Engine Company, Boeing, General Electric Aircraft Engines, and Lockheed Martin.
The AS 9100 expands upon the concepts of the ISO 9001, and includes requirements specific to aviation, with a heavier focus on quality, safety, and risk management.
The 3 stage auditing process requires a pre-audit assessment, as well as a 2 part initial audit performed by an external auditor. Additionally, a nominated auditor is required to visit your organization every six months to a year to ensure continued management standards, as well as perform a reassessment of your management system every three years.
ISO/TS 16949- Automotive
The ISO/TS 16949 is specifically written for manufacturers working within the automotive industry, and currently about 30 percent of automobile manufacturers utilize this standard. The standard focuses mainly on increasing overall quality and maximizing customer satisfaction by identifying risks and problems in the production process and supply chain. It puts particular significance on defect prevention and the reduction of variation within the manufacturer's supply chain.
Certification requires a two stage auditing process, as well as a reassessment every three years after certification is received. The organization must be able to demonstrate that it has 12 months of performance data for all manufactured automotive products.
