Welcome
A competitive economy, there has to be checks and balances in operation. Otherwise, it will be hard to ensure continuity and efficiency through sectors and nations. Global laws are targeted at establishing a fair playing field and ISO is one such organization.
What does certification according to ISO mean?
ISO certification certifies that a design system, process, plant, or monitoring procedure applies to both standardization and quality assurance requirements. ISO (International Standardization Organization) is a private, independent, non-governmental organization providing guidelines for the quality, safety, and durability of products, services, and systems.
ISO certifications exist in many market areas, spanning from energy sustainability and organizational transparency to medicinal equipment, and waste management. The ISO Standards are in place to maintain consistency. Each certification requires different skills and criteria and is assessed numerically. ISO Pros in Philadelphia, Pennsylvania (PA) is here to assist you with everything ISO certifications.
ISO 45001
Top management will show its engagement and cooperation with the OHSMS by active involvement, taking OHS progress in strategic planning into consideration. Top management can also contribute to OHSMS ‘s growth by playing an active part in directing, promoting, and communicating with staff, and cultivating and influencing the company’s OHSMS culture.
The suggested framework defines specifically the Highest Management Responsibility and Transparency Criteria for Health and Security at Work. This is to ensure that ultimate responsibility can not be delegated to health and safety or to other managers within an organization.
Consultation and participation
The standard needs the organization’s top management to promote collaboration and participation by staff and their members, as they are essential influences in the management of OHS. Consultation requires communication in two-ways – exchanges and dialogue – which includes supplying relevant input that staff and their members need, so a decision can be taken by the organization.
The OHS management system depends on worker participation, which allows workers to contribute to decision making on OHS performance and to provide feedback on proposed changes. The organization should encourage staff at all levels to recognize hazardous conditions and prevention steps can be put in motion and disciplinary action can be taken. Workers must also have a role in communicating and recommending areas for improvement without being scared of retaliation, disciplinary action, or related reprisals.
ISO 9001
ISO 9001 is a recognized quality assurance standard and one of the most frequently employed certification frameworks in the world. Moreover, more than one million companies and associations in more than 170 countries are accredited to ISO9001. The Quality Management System Framework extends to any company irrespective of size or market, providing guidelines and resources for companies and organizations that want to ensure:
- Its products and services consistently satisfy customer requirements
- Consistent improvement of quality
- They adopt the best standards within their enterprise
ISO9001 has a strong focus on:
- The consumer experience and it developing to the benefit of the company
- Engagement in organization, development, and management
- Improving market processes for demand management and risk control
- Fine-tune management procedures to optimize capital and allow for business growth
Getting ISO 9001 certified gives companies certain advantages over their competitors:
- Added a competitive edge
- Customer service enhanced
- Better performance, lower prices help to improve operating profit
- Ability to compete in emerging countries and to attract new consumers
- Enables businesses to grow and have the systems in place to efficiently manage the increased business growth and maximize investment returns.
The International Organization for Standardization ( ISO) has revised the ISO 9001:2008 standard to ensure the specification is applicable in the market world today. These include:
- Bring a fresh approach and views
- Emphasis on risk-based analysis, change management and operational know-how
- Maintain profitability for firms competing in the growing consumer market
- Integration in other standard frameworks, e.g. ISO 14001
- Provide a solid foundation for the coming 10 years
- Ensure the standard reflects the requirements of the service providers
- Develop an enterprise’s ability to meet its client’s needs
ISO 14001
Consumers, customers, and stakeholders are increasingly worried about the environmental effect of their behavior, their products, and the energy they use. We want businesses to follow expectations of quality and show dedication and create a daily positive effect on the climate. This may be a challenge but it is also an opportunity for you to demonstrate your responsibility for the environment, stand out from the competition, and demonstrate evidence of your commitment to existing and potential customers.
The benefits:
- Provides effective monitoring of environmental problems
- Greater funding for environmental legislation
- Preventing emissions
- Lowers use of energy and utilities and thus reduces operating costs
- Eco-performance tends to increase
- Reduces the possibility of penalties and prevents charges
- Growing trust among stakeholders
- Improves staff productivity
- Fresh market perspectives for environmentally friendly clients
Demonstrate a high level of environmental compliance while bidding for international contracts / rising locally to please the client. ISO Pros in Philadelphia, Pennsylvania (PA) gives a broad variety of ISO 14001 certification customized to suit the organization’s specifications. Please contact the nearest branch for more details.
Transitioning to ISO 14001
All undertakings not approved in compliance with ISO 14001 will have three years to complete the transition. However we recommend you make a transition at the stage of the three-year reassessment study, so you have to decide when to make the move. We provide a broad variety of solutions to help you make the transition from ISO 14001 to meet the 2015 demands.
The spectrum of tools includes the recognition of variations, scheduling, including in-house management meetings and transition planning and facilitation workshops, and reviews, all designed to allow the move to the new standard(s) goes as smoothly as possible.
ISO 13485
ISO 13485 is intended for any entity that is fully or partially engaged in the life-cycle of medical equipment, and the specifications of these requirements extend to organizations regardless of their size and shape, except as expressly stated.
For a company that operates an ISO-13485-compliant QMS and it outsources any process that involves requirements (e.g. labeling, servicing), the company requires the outsourced procedures to be kept under supervision. To this end, it is necessary to establish written quality agreements with the subcontractor (whether it is a different company or an individual), with detailed roles and responsibilities for all relevant outsourced activities.
Suppliers or other outside parties (such as contract manufacturers or distributors) who supply products or services to medical device organizations may also use ISO 13485. Implementation by a supplier or outside party of an ISO-13485-compliant QMS may be a voluntary choice (e.g. for competitive advantage) or may be mandated by regulatory requirements in a given country, or maybe a contractual request from the customer.
An organization can elect to build an ISO 13485 compliant QMS without obtaining approval from an authorized body. Given the considerable effort to set up a QMS-compliant medical device, the ultimate goal should be to achieve conformity acknowledgment by ISO 13485 registration, since it represents a significant advantage in meeting customer and regulatory needs.
This is necessary to note that in some nations certification is a legal standard, either as a condition for the legal approval of medical devices or for other organizations within the supply chain of medical devices. Overall, a medical device maker is required to obtain ISO 13485 approval in most countries.
AS9100
There is no relief from the fact that for the businesses awaiting their certification, AS9100 is more of a must-have. If you’re a seller or supplier of products or just about anything that travels, if you don’t have the right credentials, you’re absolutely unable to engage in all things related to aerospace.
This is not as much a problem for bigger companies as it is more common for a multi-million or trillion-dollar enterprise to actually have the financial capital at their fingertips. Supporting hiring a full-time boss (and potentially a staff) to conduct regular audits and do all the fun stuff that involves keeping an international certification such as AS9100 is only a question of payroll to them.
But what if things aren’t that easy? That is simply not the case with small and medium-sized enterprises engaged in the supply chain for aerospace. Cost/benefit is so much more of an issue as margins are pushed to the brink. If this is you, then you realize that you can not push anywhere near an aircraft with a single button unless you can obtain or retain the relevant certification … AS9100. Speak to ISO Pros in Philadelphia, Pennsylvania (PA) today for assistance.
The Aerospace standard AS9100 is the global quality management framework most widely used in the aerospace industry. All the firms leading in the aerospace industry and their supply chains are obeying this standard. It is important to make the quality control program more successful for all businesses that operate in the aerospace industry. It covers all the major retail, building, engineering, and maintenance businesses. In the near future, once the organization succeeds in securing the AS9100 certification, remarkable results can be anticipated as working with an AS9100 certified organization is the basic requirement with established companies and suppliers.
IATF 16949
This is the international benchmark for quality control programs in the automobile industry. An IATF 16949 certificate confirms that the business has been audited and found to be in accordance with the regulation and applicable consumer specific requirements.
What does IATF 16949 represent?
IATF 16949 was developed by leading manufacturers of automobiles worldwide. It is based on ISO 9001 and national quality standards in the automotive industry and can be easily integrated with already in-use standards. This standard extends to all vehicle supply chain suppliers globally-for vehicles, their parts, materials, or systems.
Why certify to standard IATF 16949?
Quality control program designation shows both dedication to product safety and customer-specific criteria enforcement. The framework calls for an ongoing mechanism to help you identify and track places for strengthening your management structure and associated processes inside your company.
A manufacturer authorized by ISO Pros in Philadelphia, Pennsylvania (PA) for an IATF 16949 credential is directly placed into a supply database worldwide. The database is used exclusively by the original equipment manufacturers (OEM) to keep up-to-date with their suppliers’ certification status and performance. Certification is also a prerequisite to a deal.
An organization certified by IATF 16949 include the following benefits:
- Improved procedures, and consistent quality.
- Reduced need for numerous audits from second and third parties.
- Improved confidence when applying for major procurement contracts.
- Guaranteed reputation when vying for national procurement contracts or locally developing sectors.
Reducing output variability and increasing processing performance, greatly affecting the outcomes at the end.
CMMC
What is the Framework Certification for Cybersecurity Maturity (CMMC)?
CMMC is a tool the U.S. Department of Defense will utilize (starting in mid-2020) to ensure that sufficient cybersecurity safeguards are in effect to secure ‘managed unclassified knowledge’ or CUI stored on defense industrial base networks (i.e. DoD contractors). CMMC replaces NIST SP 800-171. A network protection strategy (SSP) and action plan & goal (POA&M) do no longer serve to satisfy the specifications of the military procurement agency. The faster companies continue to focus on their cybersecurity plan, the more likely they are to receive a better ranking, enabling them to gain further contracts.
What impact will NIST SP 800-171 & CMMC make?
The CMMC combines standards in cybersecurity control like NIST SP 800-171 as well as ISO 27001. This creates one unified standard in cybersecurity. Not only does the CMMC aim at applying the cybersecurity regulations of an entity, but would also determine the sophistication of cybersecurity activities of an enterprise, something that was not recognized under the NIST SP 800-171 process. Contractors will be assigned maturity levels based on the state of their cybersecurity program with 1 being the lowest rating and 5 being the highest rating.
CMMI
The Capability Maturity Model Implementation, or CMMI, is a methodology that helps companies enhance operations and establish habits that reduce company, product, and device creation risks. Although CMMI was originally geared to electronics, the new edition is even less limited and can be extended to all sectors including equipment, software, and service creation. The model helps companies to assess, develop, and strengthen capacities and thereby increase organizational efficiency.
CMMI ‘s primary goal is to develop ‘reliable ecosystems in which goods, facilities, and organizations are constructive, effective, and successful.’ More importantly, CMMI ‘s corporate goals involve encouraging the company to deliver superior facilities or items; raising consumer satisfaction; growing stockholder value; gaining industry-wide acceptance of excellence, and creating excellence; According to the Carnegie Mellon Computer Engineering Institute, which was central to its creation, CMMI seeks to help “integrate historically separate organizational roles, establish targets and objectives for process change, provide recommendations for quality processes and provide a reference point for evaluating existing processes.”