Quality Labs

5s is the name of a workplace organization methodology that uses a list of five Japanese words which are Seiri, Seiton, Seiso, Seiketsu and Shitsuke.  transliterated or translated into English, they all start with the letter "s". The list describes how items are stored and how the new order is maintained. The decision-making process usually comes from a dialogue about standardization which builds a clear understanding among employees of how work should be done. It also instills ownership of the process in each employee.

Phases of 5s

There are 5 primary phases of 5s: Sorting, Straightening, Systematic cleaning, Standardizing and Sustaining. Additionally, there are two other phases sometimes included, safety & security.

Sorting (Seiri)

Eliminate all unnecessary tools, parts, and instructions. Go through all tools, materials, and so forth in the plant and work area. Keep only essential items and eliminate what is not required, prioritizing things as per requirements and keeping them in easily-accessible places. Everything else is stored or discarded.

Straightening or setting in order/stabilize (Seiton)

There should be a place for everything and everything should be in its place. The place for each item should be clearly labeled or demarcated. Items should be arranged in a manner that promotes efficient work flow. Workers should not have to bend repetitively to access materials. Each tool, part, supply or piece of equipment should be kept close to where it will be used – in other words, straightening the flow path. Seiton is one of the features that distinguishes 5s from "standardized cleanup". This phase can also be referred to as simplifying.

Sweeping or shining or cleanliness/systematic cleaning (Seiso)

Keep the workplace tidy and organized. At the end of each shift, clean the work area and be sure everything is restored to its place. This makes it easy to know what goes where and ensures that everything is where it belongs. A key point is that maintaining cleanliness should be part of the daily work – not an occasional activity initiated when things get too messy.

Standardizing (Seiketsu)

Work practices should be consistent and standardized. All work stations should be identical. All employees should be able to work in any station doing the same job with the same tools that are in the same location in every station. Everyone should know exactly what his or her responsibilities are for adhering to the first 3 S'.

Sustaining the discipline or self-discipline (Shitsuke)

Maintain and review standards. Once the previous 4 S' have been established, they become the new way to operate. Maintain focus on this new way and do not allow a gradual decline back to the old ways. While thinking about the new way, also be thinking about yet better ways. When an issue arises such as a suggested improvement, a new way of working, a new tool or a new output requirement, review the first 4 s's and make changes as appropriate.

ISO 10002 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.

ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.

It is also intended for use by organizations of all sizes and in all sectors.

ISO 10002:2004 addresses the following aspects of complaints handling:

• Enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service.
• Top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training.
• Recognizing and addressing the needs and expectations of complainants.
• Providing complainants with an open, effective and easy-to-use complaints process.
• Analyzing and evaluating complaints in order to improve the product and customer service quality.
• Auditing of the complaints-handling process.
• Reviewing the effectiveness and efficiency of the complaints-handling process.

• Customer Retention

• Brand Reputation

• Operational Efficiency

• Improved Internal Communication and Relation

• Continual Improvement

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. This standard supersedes earlier documents such as en 46001 and en 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488(also 1996).

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 continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Other specific differences includes:

• The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 cfr 820 quality system regulation for medical devices sold in the united states.
• 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.
• Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of medical devices and in-vitro diagnostic medical device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the quality management system according ISO 9001 and/or ISO 13485 and ISO 14971 by a notified body. The result of a positive assessment is the certificate of conformity allowing the Ce marking and the permission to sell the medical device in the European union.

ISO 14001 is an internationally accepted standard that sets out a framework of essential elements for putting an effective Environmental Management System (EMS) in place. The standard is designed to address the delicate balance between maintaining profitability and reducing environmental impact.

The ISO 14001 Environmental Management Systems (EMS) certification enables organizations to demonstrate  commitment to the environment. The standard provides guidance on management of the environmental aspects of business activities more effectively, while taking into consideration environmental protection, pollution prevention and socio-economic needs.

Furthermore, it assists  organization to ensure compliance with environmental legislation and reduces the risk of penalties and possible litigation. Demonstrating commitment to the environment can transform  corporate culture externally by opening up new business opportunities with environmentally aware customers or clients. Internally, it can improve employee ethics and the workplace. ISO 14001 compliance can also provide organization with a better use of energy and resources, and reduce costs over time.

Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.

ISO 9001 is by far the world’s most established quality framework, currently being used by over 3/4 million organizations in 161 countries, and sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 9000 series of standards

ISO 9001 is one of a series of quality management system standards. It can help bring out the best in your organization by enabling you to understand your processes for delivering your products/services to your customers. The ISO 9001 series of standards consist of:

• ISO 9000 – fundamentals and vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
• ISO 9001 – requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
• ISO 9004 – guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.

ISO/TS 16949 (last updated in the year 2009) is an ISO technical specification which aligns existing us, German, French and Italian automotive quality system standards within the global automotive industry. It specifies the quality system requirements for the design/development, production, installation and servicing of automotive-related products.

The global automotive industry demands world class levels of product quality, productivity and competitiveness as well as continual improvement. To achieve this goal many vehicle manufacturers insist that suppliers adhere to strict technical specifications laid out in a quality management standard for suppliers to the automotive sector, known as ISO/TS 16949.

ISO/TS 16949 has been developed by the industry, the International Automotive Task Force (IATF), to encourage improvement in both the supply chain and the certification process. In fact, for the majority of leading vehicle manufacturers, certification to this specification is a mandatory requirement for doing business.

This specification aligns and supersedes existing us, German, French and Italian automotive quality system standards, including QS-9000, VDA6. 1, EAQF and ASQ. It specifies the quality system requirements for the design/development, production, installation and servicing of all automotive-related products. First published in march 1999 and revised in 2002, there are now over 25,000 certificates issued in 80 countries and economies.

OHSAS 18001 is the international occupational health and safety management standard.

It was published in July 2007, superseding OHSAS 18001:1999, and is intended to address occupational health and safety (oh&s) rather than product safety.

OHSAS 18001 provides a framework to the effective management of oh&s including compliance with the legislation that applies to your activities and identified hazards.

Who is OHSAS 18001 applicable to?

The standard is applicable to any organization that wishes to eliminate or minimize risk to employees and other stakeholders who may be exposed to oh&s risks associated with its activities.

Many organizations will have elements required by OHSAS 18001 already in place which can be supplemented to provide a more cohesive management system to meet the requirements of the standard.

Organizations that implement ohsas 18001 have a clear management structure with defined authority and responsibility, clear objectives for improvement, with measurable results and a structured approach to risk assessment. This includes the monitoring of health and safety management failures, auditing of performance and review of policies and objectives.

We offer a complete range of RoHS(Restriction of Hazardous Substances) certifications that specifies the restriction of the usage of hazardous compounds & substances in electrical as well as electronic equipments. The compounds that are banned under RoHS include lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers. This certifications is playing an active role in saving the environments from dangerous pollution effects.