Consulting

Our ideal client is:

interested in ISO 9001 or AS9100 certification
is already certified
wants to use the standards to organize the quality system
is currently a supplier to an AS9100 company
is looking to sell a service or product to an AS9100 certified company

We enjoy working with C-level executives because leadership, strategic planning and risk management are vital for building a quality culture in the organization. Leadership is one of the quality management principles we discuss when working with the executives.

ISO 9001

(International Organization for Standardization)

www.iso.org

ISO 9001 is a standard that provides guidance to set up and manage a quality management system. Organizations can use the standard to meet or exceed customer requirements without being certified.

Adopting a Quality Management System (QMS) is a strategic direction organizations can use to improve organizational performance. Implementing a QMS based on ISO 9001:2015 has many benefits, such as:

The ability to consistently provide services and products to meet and exceed customer, regulatory, and statutory requirements;
Addressing Risk and Opportunities
Focusing on opportunities to improve customer satisfaction;
Demonstrating conformance to QMS requirements.

The standard has seven Quality Management Principles that are considered rules or beliefs that are considered to be true and can be used as a foundation for developing the quality management system and performance improvement.

Customer Focus
Leadership
People Involvement
Process Approach
Improvement
Evidence-based decision-making
Relationship Management

The standard utilizes the process approach by incorporating Plan-Do-Check-Act (PDCA) and thinking about risks.

ISO 9001 uses a process approach by reviewing the interaction of the processes and evaluating the intended results with the outcome. Using the process approach with a quality management system helps:

Accomplish effective process performance
Determine how processes add value
Process improvement by evaluating information and data
Realize the importance of meeting requirements consistently

In our experience, we have seen how this quality management standard forces organizations to look at the big picture through the eyes of the customers and the employees. This increases customer satisfaction and people engagement which ultimately increases the bottom-line.

Understanding the organizational structure and strategies, company culture, employee communication and interaction, and customer base are elements we discuss to provide guidance regarding the approach to quality management.

Recommendations

ISO 9001:2015 Quality Management Systems - Requirements

AS9100

This standard includes ISO 9001:2015 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions, and notes.

It is emphasized that the requirements specified in this standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.

If there is a conflict between the requirements of this standard and customer or applicable statutory or regulatory requirements, the latter shall take precedence.

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

a. needs to demonstrate its ability to consistently provide products and services that meet customer and applicable

statutory and regulatory requirements, and

b. aims to enhance customer satisfaction through the effective application of the system, including processes for

improvement of the system and the assurance of conformity to customer and applicable statutory and

regulatory requirements.

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

NOTE 1: In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.

NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements.

(Reference AS9100D )

ISO 9001 is the foundation and includes some additional requirements and notes, such as:

Customer Focus relating to measuring product and service conformity and on-time delivery performance.
Management Representative having freedom and unrestricted access to top management.
Using a Quality Manual to describe the QMS
Process for recalling measuring and monitoring equipment requirement verification or calibration.
Competence Review
Employee Awareness for contributing to product safety, service or product conformity, and importance of ethical behavior
Operational Risk Management
Configuration Management
Prevention of Counterfeit Parts
Foreign Object Debris/Damage (FOD) Prevention
Responsibilities for External Products, Processes and Services
Control of Production and Service Provision (Equipment, Tools, Software, Validation and Control of Special Processes)