Quality Management System
QUALITY MANAGEMENT SYSTEM (QMS)
Quality management is the act of overseeing all activities and tasks in an organisation needed to maintain a desired level of excellence. Quality management includes the determination of a quality policy, creating and implementing procedures to achieve quality improvement.
Quality management involves interlinking of different activities and tasks within an organization to ensure that products and services offered, as well as the means used to provide them, are consistent with the quality policy and defined procedures. It helps to achieve and maintain a desired level of quality within the organization.
Today, the sector-specific quality management system requirements have been evolved for various sectors like, aviation & space industry, medical devices industry, automotive industry etc.
ISO 9001 - QUALITY MANAGEMENT SYSTEM
The standard ISO 9001:2015 was the very first standard that set out the quality management system and its requirements. Even today, it is the most popular management system standard because of its easy applicability for any organization, large or small, regardless of the field of activity. In fact, there are over one million companies and organizations in over 170 countries, certified to ISO 9001.
ISO 9001 sets out the requirements for a QMS and is the only standard in the ISO 9000 family (https://www.iso.org/iso-9001-quality-management.html) that can be certified to. This standard is based on seven quality management principles which are:
• Customer focus
• Engagement of people
• Process approach
• Evidence-based decision making
• 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.
Using ISO 9001 helps organisations ensure that their customers get consistent, excellent quality products and services, which in turn brings many business benefits. (https://www.iso.org/standard/62085.html)
AS 9100 - QUALITY MANAGEMENT SYSTEM FOR AVIATION, SPACE AND DEFENCE ORGANIZATIONS
The Aerospace Quality Management System Standard AS 9100 deals with:
‒ Internationally recognised framework for best practices in aviation, space and defence organizations
‒ Addressing the unique needs of manufacturers, maintenance and repair operations and distributors.
‒ Providing multiple benefits to companies who chose to adopt the requirement of standard.
‒ Providing a variety of aerospace sector-specific requirements, while include all the existing elements of QMS and a variety of aerospace sector-specific requirements.
‒ The Aerospace standards seek to:
o Improve customer satisfaction, quality & safety
o Reduce costs & lower customer-unique requirements
o Reduce the variation caused by multiple expectations
o 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:
o 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.
o Design – ensures that design responsible organizations have a robust design process to meet safety and reliability requirements demanded by the aerospace industry.
o Purchasing – requires suitable controls over the organization’s entire aerospace supply chain.
o Product Realization – ensures that each phase of product realization, from planning to shipment, is tightly controlled for delivery of conforming product.
o Product Monitoring / Measurement – that defines requirements for product validation prior to shipment.
o Product documentation and identification
AS 9110 - QUALITY MANAGEMENT SYSTEM FOR AVIATION MAINTENANCE ORGANIZATIONS
The aerospace industry realized that the needs of the Maintenance, Repair and Overhaul (MRO) segment were different from those of the OEM segment. Products are designed to perform for 50 years and beyond, so proper maintenance is crucial for safe operation. Hence, 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 the MR&O requirements 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 sound system to ensure safety, reliability and airworthiness.
AS 9110 provides organisations with a comprehensive quality system focused on areas directly impacting product safety and reliability, such as:
• civil aviation authorities and their requirements.
• definitions unique to the MR&O industry such as, Maintenance, Technical Data, and Human Factors & Release Certificates.
• requirements for personnel conducting MR&O task.
• qualification of new maintenance processes
AS 9120 QUALITY MANAGEMENT SYSTEM FOR AVIATION, SPACE, AND DEFENCE DISTRIBUTORS
Distributors buy and resell aerospace commodity items such as raw materials, fasteners, bearings, paints, coatings, and gaskets. While not adding value to these products, distributors directly affect product performance if they fail to handle the parts and the materials properly or lose a part’s traceability from OEM to customer.
This standard AS 9120 was developed exclusively for pass-through distributors of aerospace commodity items. This standard addresses the chain of custody, traceability, control and availability of records.
The standard addresses the requirements that the 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 alarming 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 – Defines specific requirements for control of records pertaining to distributors of aerospace product.
• Traceability – Defines specific requirements for traceability from receipt until delivery.
• Evidence of Conformance – Defines those requirements for specific documents that are required by distributors as evidence of conformance.
ISO/TS 16949 AUTOMOTIVE QUALITY MANAGEMENT
ISO/TS 16949 is the globally recognized quality management standard for the automotive industry. It brings together standards from across Europe and the US and provides a framework for achieving best practice with regards to the design and manufacture of products for the automotive supply chain.
The standard has been developed by the International Automotive Task Force (IATF) and brings together common processes from across the industry sector. IATF comprises of vehicle manufacturers like – Ford, GM, Chrysler, BMW, VW, Daimler, Renault, PSA Peugeot Citroen and Fiat – along with national automotive trade organizations from USA, UK, France, Germany and Italy.
ISO/TS 16949 is based on the quality management system standard, ISO 9001, and promotes continual business improvement by emphasizing defect prevention and reducing variation and waste in the supply chain. Certification to ISO/TS 16949 is often a requirement for doing business internationally in the automotive sector – not only does it help open up global business opportunities but is now considered a robust management tool to help organizations within the industry grow, compete and succeed.
ISO/TS 16949 standard is proven to help deliver tangible commercial improvements such as:
• Enhanced corporate reputation – by demonstrating compliance with industry and legal requirements
• Improved customer satisfaction – through delivery of products that consistently meet customer requirements
• Ability to win more business – via easier access to global markets and new business and investment prospects
• Improved operational processes and greater efficiency – through implementation of a single management system and reduced audit requirements
• Improved risk management – through greater consistency and traceability of products and services
ISO 13485 - MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEM
ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of the QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.
The benefits of implementing ISO13485 include:
• Improved credibility and image – Certification to this standard shows clients and customers that your company takes quality very seriously, and that you have a system in place to ensure it.
• Improved customer satisfaction – Customers know what they want, and what they need, and many of them will not even entertain a supplier that is not certified.
• Improved processes – Using the process approach one will be able to identify and eliminate waste within and between processes, reduce errors, and avoid rework—facilitating greater efficiency and cost savings.
• Improved decision making – With the use of evidence-based decision making, the decisions tend to be better aligned with the strategic goals of your company.
• Creates a culture of continual improvement – The standard encourages the leadership team and staff to always be on the lookout for ways to improve on how things are done. By establishing systematic processes for reducing problems and mitigating their effects, everyone will spend less time cleaning up mistakes, and more time delivering quality products and services.
• Better employee engagement – Clarity in roles and responsibilities leads to increased efficiency and productivity. When employees are asked to help, they look for ways to improve their own processes, not only will they often provide the best insight – they will also be much happier and more invested in the success of the company.
ISO 15378 - QUALITY MANAGEMENT SYSTEM FOR MEDICINAL PACKAGING MATERIALS
The ISO 15378 sets out the QMS guidelines for manufacture of primary packaging materials for medicinal products.
The standard also provide framework for legal compliance, identification, traceability, validation, reduction and control of risks like contamination and production defects.
This standard brings in benefits like:
• Improvement in processes.
• Cost minimization,
• Assurance of quality of products to customers,
• Minimization or elimination instances of contamination,
• Reduction in mistakes and mix-ups,
• Reduction of manufacturing errors
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