Quality Management system (ISO 9001)
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. The seven quality management principles are:
- • QMP 1 - Customer focus
- • QMP 2 – Leadership
- • QMP 3 - Engagement of people
- • QMP 4 - Process approach
- • QMP 5 – Improvement
- • QMP 6 - Evidence-based decision making
- • QMP 7 - Relationship management
These principles are not listed in priority order. The relative importance of each principle will vary from organization to organization and can be expected to change over time. Please read http://www.iso.org/iso/pub100080.pdf
Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
Aerospace Quality Management system
The Aerospace Quality Management System Standards AS 9100, AS 9110, AS 9120 specific to the industry provide:
- • Internationally recognised frameworks for best practices.
- • Addressing the unique needs of manufacturers, maintenance and repair operations and distributors.
- • Providing multiple benefits to companies who chose to adopt the standards’ requirements.
These standards were developed to produce a harmonized platform to ensure that all operations in the supply chain are adhering to best practice. They include all the existing elements of QMS and a variety of aerospace sector-specific requirements.
The Aerospace standards seek to:
- • Improve customer satisfaction, quality & safety
- • Reduce costs & lower customer-unique requirements
- • Reduce the variation caused by multiple expectations
- • Reduce and streamline audits conducted along the aerospace supply chain.
The Aerospace Quality standard is based on ISO 9001, with nearly 100 additional requirements specific to aerospace. AS 9100 provides suppliers with a comprehensive quality system focused on areas directly impacting product safety and reliability in the aerospace industry, including:
- - Configuration Management - requires that a management discipline be applied over the life cycle of an aerospace product to provide visibility and control of its functional and physical characteristics
- - Design - ensures that design responsible organizations have a robust design process to meet safety and reliability requirements demanded by the aerospace industry
- - Purchasing - requires suitable controls over the organization's entire aerospace supply chain
- - Product Realization - ensures that each phase of product realization, from planning to shipment, is tightly controlled for delivery of conforming product
- - Product Monitoring/Measurement - that defines requirements for product validation prior to shipment.
- - Product documentation and identification
AS 9110 Aerospace Series - Quality Systems - Model For Quality Assurance Applicable To Maintenance Organizations
The aerospace industry realized that the needs of the Maintenance, Repair and Overhaul (MRO) segment were different than those of the OEM segment. Products are designed to perform for 50 years and beyond, so proper maintenance is crucial for safe operation and hence this Standard. To address this need, the IAQG (International Aerospace Quality Group) has developed AS 9110.This standard focuses on the control of repair schemes and maintenance plans, configuration management, and the skills and qualifications necessary to perform MRO tasks within the aerospace community.
The AS 9110 standard addresses many of the MR&O requirements that are identified in the US FAA (Federal Aviation Administration) Federal Aviation Regulation (FAR) Part 43 & 145. These include topics such as, approvals, ratings, licenses and permits. MR&O organizations must have a series of approvals for certain types of repairs, they must be rated on the specific airframe and/or engine platform and carry the appropriate regulatory certificates. Other requirements include technical data (repair manuals), personnel certification and validation of the maintenance activity. Effective implementation of AS 9110 will provide an organization with a good sound system to ensure safety, reliability and airworthiness.
AS 9110 provides suppliers with a comprehensive quality system focused on areas directly impacting product safety and reliability, such as;
- • Addresses civil aviation authorities and the requirements.
- • Addresses definitions unique to the MR&O industry such as, Maintenance, Technical Data, and Human Factors & Release Certificates.
- • Includes expanded requirements for personnel conducting MR&O task.
- • Addresses the qualification of new maintenance processes
AS 9120 Aerospace for Stockist Distributors
Distributors buy and resell aerospace commodity items such as raw materials, fasteners, bearings, paints and coatings and gaskets. While not adding value to these products, distributors directly affect product performance if they fail to handle parts and materials properly, or lose a part's traceability from OEM to customer.
AS 9120 Quality Management Systems - Aerospace Requirements for Stockist Distributors
This standard was developed for pass-through distributors of aerospace commodity items. This standard addresses chain of custody, traceability, control and availability of records.
The standard addresses requirements that distributors must focus on to ensure that only approved, conforming parts make their way into the supply chain. In recent years the concern of "black market" or "bogus" parts has reached heightened levels. AS 9120 includes requirements that effectively implemented, would help a distributor minimize the risk of such activity.
AS 9120 provides suppliers with a comprehensive quality system focused on areas directly impacting product safety and reliability including;
- • Splitting - Specific requirements for batch splitting and lot splitting, and how conformance to specification is maintained.
- • Airworthiness certificates - Defines the documents issued by cognizant civil aviation authorities that certifies that parts meet the required airworthiness requirements.
- • Control of records - Record requirements differs significantly for distributors of aerospace product. AS9120 defines those requirements.
- • Traceability - Defines specific requirements for traceability from receipt until delivery.
- • Evidence of Conformance - Specific documents are required by distributors as evidence of conformance. AS9120 defines those requirements.
Benefits of AS standards:
When your organization aligns to the aerospace AS 9100 standard, it not only reaps quality and efficiency benefits, but also is better able to meet customer expectations. Registration can also provide a competitive advantage through:
- • Identification of opportunities for operational improvements and cost reduction by Aerospace Experienced Auditors (AEAs)
- • Reduction in number of customer audits corresponding reduction in resource requirements.
- • Enhanced supplier performance due to higher quality, waste reduction, and a customer satisfaction focus;
- • Streamlined documentation.
Quality management systems for automotive production and relevant service part organizations (ISO/TS 16949)
This is the global technical specification and quality management standard for the automotive industry. It brings together standards from across Europe and the US. ISO/TS 16949 outlines everything you need to know about achieving best practice when designing, developing, manufacturing, installing or servicing automotive products.
The international automotive taskforce (IATF), which members include major OEMs and ISO are committed to ensuring that TS 16949 remains the Automotive Quality Management System standard for the future.
It is a standard applicable to sites of an organization where customer specified parts, for production and/or service, are manufactured. A key requirement of ISO/TS 16949:2009 is the fulfilment of customer-specific requirements, set up by the car manufacturer (OEM) in addition to the quality management system of their suppliers. This may have decisively contributed to the worldwide recognition of the standard by many car manufacturers (OEMs). History in brief many suppliers were in the past asked by the car manufacturers (OEMs) to build and certify their quality management system according to the rules and regulations of their own country organizations, such as VDA (Germany), AIAG (North America), AVSQ (Italy), FIEV (France) and SMMT (UK). Suppliers needed to provide several different certificates to their customers. These complexities accelerated the need for harmonization. The result was the ISO/TS 16949 and the first edition was published in March 2002 as ISO/TS 16949:2002. The ISO/TS 16949 was jointly developed by the International Automotive Task Force (IATF) members and submitted to the International Organization for Standardization (ISO) for approval and publication. Certification A certification takes place on the basis of the certification rules issued by the International Automotive Task Force (IATF). The certificate is valid for the length of three years and must be confirmed annually by an IATF certified auditor (3rd Party Auditor) of an accredited certification body. A certificate according to ISO/TS 16949 is intended to build up or enforce the confidence of a (potential) customer into the system and process quality of a (potential) supplier. Today, a supplier without a valid certificate has very little chance to serve a Tier 1 supplier and certainly no chance to serve a car manufacturer (OEM) with standard parts.
Main benefits of adopting this standard are:
- - Global recognition
- - Customer satisfactions
- - Reduced cost
- - Improvement in stakeholders confidence & relationships
- - Legal compliance
- - Risk management
- - Increase in business
Quality Management system for Medical devices (ISO 13485)
This Standard (ISO 13485) is developed to harmonize the medical services manufacturing regularity requirements and is essentially built on QMS requirements. ISO 13485:2003 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.
ISO 13485 is also applicable for all organization involved in medical devices business from manufacturing to delivery with the additional CE marking requirements depending on the category of medical devices.
ISO 13485 Medical Devices Management Standard emphasis on:
- • Proper implementation of quality management system for safe product development and realisation by adopting Risk Management approach.
- • Regulatory and statutory compliance.
- • Efficient product traceability and recall system.
- • Increase access to more markets worldwide with certification
- • Outline how to review and improve processes across your organization
- • Increase efficiency, cut costs and monitor supply chain performance
- • Demonstrate that you produce safer and more effective medical devices
- • Meet regulatory requirements and customer expectations
Quality Management System for Medicinal Packaging Materials Supplier (ISO 15378)
The ISO 15378 includes important QMS guideline for primary manufacture of glass, plastic, rubber, aluminium and other medical packaging materials. The standard also provide framework for legal compliance, identification, traceability, validation, reduction and control of risks (like contamination and our production defects).
Obtaining certification to this standard brings manifold benefits:
- • Improvement in processes
- • cost minimization for certified organization
- • additional assurance of quality products to your customers
- • minimization or elimination instances of contamination
- • reduction in mistaken mix-ups
- • reduction of manufacturing errors