ISO Quality Management

 
ISO 9001 Certification
ISO 9001:2008

ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family of ISO 9000 standards to which a company can be certified.  It is almost universally accepted as a truly international standard. All companies exporting products or services to the European Union (EU) may someday be contractually required to have ISO certification to sell into the market. Even today, contractual requirements are finding their way into purchase orders for products manufactured in Japan, the United States and elsewhere. Currently, the requirement for ISO 9001 registration is clearly market-driven.

 

Most of the requirements are just sheer good business sense. For example, there are requirements that you must know what your customers want, and deliver it to them. You must make sure your people are competent and that they have the right skills, training and experience.  You need processes suitable for producing and delivering your products or services.

Companies are now registered to the current revision ISO 9001:2008 only.

 

The Standard is based on these 8 underlying principles:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Why an organization should implement ISO 9001

Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.


Most companies that have implemented ISO 9001 or similar systems report significant improvements in productivity due to an increase in customer satisfaction and reduction in field returns and internal failures. Effectively implemented quality systems help to define processes and develop discipline, which in turn, helps to “do things right the first time.” A published survey showed that companies that implemented a quality system for ISO 9001 reduced failure rates by 40 percent and customer returns by 54 percent, reducing total cost of nonconformance by 53 percent. Most companies that undertake the effort to implement ISO 9001 quality management systems are better prepared to satisfy their interested parties, including their customers. Some of the advantages of an effective quality system include:

 

  • Formalized systems ensure consistent quality and punctual delivery of products to the customers;
  • Fewer rejects result in less repeated work and warranty costs;
  • Errors are detected at the earliest stages and not repeated;
  • An improved awareness of company objectives;
  • Responsibilities and authorities clearly defined;
  • Improved utilization of time and materials;
  • Improved relationships with customers and suppliers;
  • The benefits of use of a recognized logo on marketing materials, if the system is registered.
  • Customer focus
  • Leadership
  • Involvement of people
  • A process approach
  • A systems approach to management
  • Continual improvement
  • A factual approach to decision making
  • Mutually beneficial supplier relationships.
8 Management Principles
ISO 9001:2015
ISO 9001:2015

Four years ago the ISO TC 176 - determined that it was necessary to create a new QMS model for the next 25 years. It was considered a “beginning of a new era in the development of quality management systems.”. The revised standard ISO 9001:2015 was made effective on September 15, 2015. The scope of the standard has not changed, however the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.

 

The 2015 version is less prescriptive and focuses on performance. Key tools are the process approach, risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.

Some of the key changes include:

  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy

  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement

  • The organization can now decide what documented information it needs and what format it should be in

  • There is now Alignment with other key management system standards through the use of a common structure and core text 

 

Companies now have until September 15, 2018 to convert to the 2015 standard.

 

 
AS 9100
AS 9100

AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.

 

This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) 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.

 

AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. Although the standard outlines industry "whats" for a quality management system, the "how tos" were deliberately left out and remain the system designers' responsibility.

 

Most companies that have implemented AS 9100 or similar systems report significant improvements in productivity due to an increase in customer satisfaction and reduction in field returns and internal failures. Effectively implemented quality systems help to define processes and develop discipline, which in turn, helps to “do things right the first time.” It is well accepted that companies that implemented a quality system for AS 9100 reduce failure rates  and customer returns and total cost . Most companies that undertake the effort to implement AS 9100 quality management systems are better prepared to satisfy their interested parties, including their customers. Some of the advantages of an effective quality system include:

 

  • Formalized systems ensure consistent quality and punctual delivery of products to the customers;

  • Fewer rejects result in less repeated work and warranty costs;

  • Errors are detected at the earliest stages and not repeated;

  • An improved awareness of company objectives;

  • Responsibilities and authorities clearly defined;

  • Improved utilization of time and materials;

  • Improved relationships with customers and suppliers;

  • The benefits of use of a recognized logo on marketing materials, if the system is registered.

 
ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Other specific differences include:

  • the promotion and awareness of regulatory requirements as a management responsibility. 

  • controls in the work environment to ensure product safety

  • focus on risk management activities and design transfer activities during product development

  • specific requirements for inspection and traceability for implantable devices

  • specific requirements for documentation and validation of processes for sterile medical devices

  • specific requirements for verification of the effectiveness of corrective and preventive actions.

 
ISO TS/16949

The ISO/TS16949 is an ISO technical specification aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001. 

It was prepared by the International Automotive Task Force (IATF) and the "Technical Committee" of ISO. It harmonizes the country-specific regulations of Quality-Management-Systems.  

About 30 percent of the more than 100 existing automobile manufacturers support the standard, but the large Asian manufacturers have differentiated their own requirements for the quality management systems for their corporate group and their suppliers. 

TS16949 applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. It is based on ISO 9001.

 
OHSAS 18001

OHSAS 18001:2007 is an international standard that is developed by the OHSAS project Group, an association that includes government agencies, certification bodies, national standards, industry associations, and consultants. The British Standards Institution (BSI) currently provides the Secretariat of the OHSAS Project Group.

The aim of OHSAS 18001 is to assist organizations in managing and controlling their health and safety risks and improving their OH&S performance.

By controlling the OH&S risks that are consistent with their OH&S policy and objectives, organizations can achieve and demonstrate sound health and safety performance and stewardship.

 
ISO 14001

ISO 14001:2004 is the most comprehensive standard for Environmental Management Systems (EMS) recognized on an international basis. It is designed to more closely align with ISO 9001:2008. The adoption of ISO 14001:2004 publicly demonstrates a commitment to environmental concerns, equipping the organization with both a valuable management system and a most powerful marketing tool.

The process of implementing and maintaining an EMS highlights opportunities for significant cost savings regardless of industry sector

 

Why Implement 14001?

An Environmental Management System (EMS) helps you to:

  • Manage environmental risk

  • Reduce costs

  • Gain competitive edge

  • Minimize environmental impact

 

What is Involved?

  • Creation of an ‘Environmental Policy’

  • Evaluation and recording of the operation’s environmental aspects/effects

  • Setting of measurable goals and targets that will comply with legislation

  • Documentation of policy objectives and proposed action

  • Audit and review

ISO 14001:2015

ISO 14001 was also updated in the year 2015. Ten elements have also been established, some additional concepts include

Top Management Responsibilities

The elements of Leadership and Performance evaluation now house these concepts within the standard. Top Management is now expected to have specific involvement in the EMS and implement system requirements into the organization’s overall business strategy and ensure intended outcomes are met for EMS goals. 

 

Environmental Performance

Now the concept is not only to review compliance and the EMS elements, but also to improve overall environmental performance of the organization. 

 

Risk-based Thinking

The current standards concept of aspects and impacts will continue to be a main part of the system. The concept of risk-based thinking is to ensure that a proactive approach is taken in determining risk for the organization. 

 

Value Chain Planning and Control

This is a new concept for the EMS standard. This introduces a requirement to review not only the significant aspects and impacts the client identifies related to their specific processes, but also ensuring that upstream and downstream processes related to the significant aspects are controlled or influenced.

 
Transitioning to ISO Revisions

AS9100, ISO 13485, TS 16949 and several more standards are scheduled for updates in 2016. Call us for more information.

 

 

 
Internal Auditor Training

To prepare for your eventual ISO certification, or to maintain your certification, your company must perform internal audits. An internal audit evaluates the effectiveness of your quality management system, and whether it adheres to the quality principles of the ISO standards. You must perform internal audits on a regular schedule. ISO auditing continues after certification, to drive continuous improvement of your quality system. 

We will train your auditors on site. We can provide certification for your auditors through a three-day training program, which also includes a sample audit of your own system.

 

Call for more detailed information.