Standards

Manufacturing Standards

ISO 9001:2015

ISO 9001:2015 specifies requirements for a quality management system where an organization:

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements

All requirements of ISO 9001:2015 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Aerospace Standards

AS9100 Aerospace/Defense

This standard AS9100 includes ISO 9001 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry. This International Standard AS9100 specifies requirements for a quality management system where an organization:

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements

AS9110 Aviation Maintenance / Repair Organizations

This standard establishes minimum requirements for the delegation of product verification to an organization’s suppliers; outlining requirements for the initial delegation (qualification/selection), maintenance, and removal/withdrawal of delegations.

AS9120 Stockist Distributors

This International Standard specifies requirements for a quality management system where an organization:

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements

AS5553 Counterfeit Parts-Electronic

This document is intended for use in aviation, space, defense, and other high performance/reliability electronic equipment applications. This standard is recommended for use by all contracting organizations that procure electronic parts, whether such parts are procured directly or integrated into electronic assemblies or equipment. The requirements of this standard are generic and intended to be applied/flowed down to all organizations that procure electronic parts, regardless of type, size, and product provided.

AS6081 Counterfeit Parts

This SAE Aerospace Standard standardizes practices to:

  • identify reliable sources to procure parts
  • assess and mitigate risk of distributing fraudulent/counterfeit parts
  • control suspect or confirmed fraudulent/counterfeit parts
  • report suspect and confirmed fraudulent/counterfeit parts to other potential users and Authority Having Jurisdiction

Standards for Medical Devices

ISO 13485 Medical Devices

ISO 13485:2014 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2014 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2014 are specific to organizations providing medical devices, regardless of the type or size of the organization.

CE Marking

The CE marking (an acronym for the French “Conformité Européenne”) certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe.

510K

A 510(K) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)6) that is not subject to premarket approval.

Environmental Standards

ISO14001 Environmental Management System

The ISO 14000 family of standards provides practical tools for companies and organizations of all kinds looking to manage their environmental responsibilities.

ISO 14001:2015 and its supporting standards such as ISO 14006:2011 focus on environmental systems to achieve this. The other standards in the family focus on specific approaches such as audits, communications, labeling and life cycle analysis, as well as environmental challenges such as climate change.

ISO 45001 Occupational Health & Safety

An occupational health and safety management system (OHSMS) promotes a safe and healthy working environment by providing a framework that helps organizations to:

  • Identify and control health and safety risks
  • Reduce the potential for accidents
  • Aid legal compliance
  • Improve overall performance

The OHSAS 18000 standards provide organizations with the elements of an effective safety management system which can be integrated with other management systems and help organizations achieve better occupational health and safety performance and economic objectives.

ISO 45001 can be aligned with existing ISO 9001 and ISO 14001 management systems. Historically many organizations start with the quality management system ISO 9001, then add the environment management requirements from ISO 14001. Many organizations now look at implementing all three standards at once which can minimize costs and disruption.

ISO 27000 Cybersecurity Consulting Services

Information security breaches are one of the biggest risks that organizations face. Sensitive data is used across all areas of businesses these days, increasing its value for legitimate and illegitimate use. 

Countless incidents occur every month, whether it’s cyber criminals hacking into a database or employees losing or misappropriating information. Wherever the data goes, the financial and reputational damage caused by a breach can be devastating. 

The ISO cybersecurity requirements were developed to combat the increasing problem of cyberattacks across the world. Unsecured data can impact your internal operations, and you can lose the trust of your customers should a catastrophic breach occur. Companies that use PQA to become compliant with ISO 27000 standards are far less likely to experience costly cyberattacks. 

The ISO/IEC 270001 family of standards, also known as the ISO 27000 series, is a series of best practices to help organizations improve their information security. 

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