ISO 13485 certification

What is iso 9001?

About ISO 9001

ISO 9001 is a quality management standard used by businesses that implement it to keep the most important aspects of running their operations and aligning business objectives with quality objectives. At CALISO, we provide the highest quality ISO 9001 training as well as a number of other training programs that fall under the same subheading. Your company and all who partake in the daily activities of running the business will benefit from taking ISO 9001 auditor training to ensure that all the proper steps and regulations are followed in all the most important areas, such as Sales, Operations and Purchasing. At CALISO, we focus a great deal of our program on ISO 9001 training and the ability to have all employees by in the ISO 9001 implementation. This way, we can ensure that your business and those working for you are getting the most done in the most proficient manner and in a way that makes your business more efficient: the end result being a more profitable venture and a well-balanced, organization



ISO 9001 Certification

The International Organization for Standardization (ISO) does not itself certify organizations. Most countries have formed accreditation bodies that approve accreditation bodies, which conduct certification audits. Although commonly referred to as ISO 9000, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies are accepted worldwide.

The organization or company seeking certification is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliance") is made known to the management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate containing each geographical site it has visited.

An ISO certificate has to be renewed, typically every 3 years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard), or is not. Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.

Industry-specific ISO 9001 based standards

The ISO 9001 standard is generic and can be used for any organization, whether it provides physical products or services. The requirements must be carefully interpreted, to make sense within a particular organization. Developing software is not like making wine or offering consulting services; yet the ISO 9001 guidelines, because they are business, management guidelines can be applied to each of these. Diverse organizations : police departments, High Schools, churches, sports teams and city councils ‹have successfully implemented ISO 9001 quality management systems.

Various industry sectors have developed interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9001 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

* AS9100 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman and Sundstrand.

* PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed and contact packaging materials.

* ISO 22000 is an application for the food industry and includes Hazard Analysis Critical Control Point (HACCP)

* The TickIT guidelines are an interpretation of ISO 9001 produced by the UK Board of Trade to suit the processes of the information technology (IT) industry, especially software development.

* ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It contains the full text of ISO 9001:2008 and automotive industry-specific requirements.

* TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. It includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.

* ISO 13485:2003 is the medical industry's equivalent of ISO 9001. Its focus is on safety and efficacy of medical devices. ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001.

ISO 9001 Effectiveness

The debate on the effectiveness of ISO 9001 commonly centers on the following:

1. Are the quality principles in ISO 9001 effective?

2. Does it help to implement an ISO 9001 compliant quality management system?

3. Does it help to obtain ISO 9001 certification?

Effectiveness of the ISO 9001 compliant quality management system (QMS) implemented depends on a number of factors, the most significant of which are:

1. Commitment of Top Management to monitor, control, and improve quality. Organizations that implement an ISO 9001 QMS without this desire and commitment, often take the cheapest road to get a certificate on the wall and do not benefit much from the standard.

2. How well the ISO 9001 QMS integrates into their business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual rather than create a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.

3. How well the ISO 9001 QMS focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be". This means that you don't necessarily have to make a product that never fails, some customers will have a higher tolerance for product failures if they always receive shipments on-time, or some other dimension of customer service. Your ISO system should take into account all areas of the customer experience, the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (your customers, your suppliers, and your organization), only then will you be able to sustain improvements in your customer experience.

4. How well the auditor finds and communicates areas of improvement. Now, ISO 9001 auditors may not provide consulting to the clients they audit, however, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard, however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands allows the companies they audit to act on improvement initiatives. When management doesn't understand why they were non-compliant and the business implications, they simply ignore the reports and focus on what they do understand.

Advantages of ISO 9001

The adoption of ISO 9001 by hundreds of thousands of companies worldwide is a good indicator on how advantageous it is to have ISO 9001. The number of certifications continues to grow and it is widely acknowledged that a QMS improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001 are also sound, and give the following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention

3. Reduce audits by customers

4. Enhance marketing ability

5. Improve employee motivation, awareness, and efficiency

6. Facilitate international trade

7. Increase profitability

8. Reduce nonconformities and increases productivity.

Problems associated with ISO 9001

A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. This is often due to the misinterpretation of the requirements of the standard, which is NOT prescriptive, and can be adapted to the size and culture of an organization.

ISO 9001 is not an indicator that products produced using its certified systems are of quality. A company can intend to produce a bad quality product and providing it does so consistently. While internationally recognized, consumers are rarely aware of ISO 9001 and it holds no relevance to them. It holds relevance for Business to Business transactions (B2B).

The standard is seen as especially prone to failure when a company is ONLY interested in certification before quality. Certifications are in fact often based on customer (B2B) REQUESTS rather than a desire to actually improve quality.

ISO 9001 Training

ISO 9001 is a quality management standard used by businesses that implement it to keep the most important aspects of running their operations and aligning business objectives with quality objectives. At CALISO, we provide the highest quality ISO 9001 training as well as a number of other training programs that fall under the same subheading. Your company and all who partake in the daily activities of running the business will benefit from takingISO 9001 auditor training to ensure that all the proper steps and regulations are followed in all the most important areas, such as Sales, Operations and Puchasing. At CALISO, we focus a great deal of our program on ISO 9001 training and the ability to have all employees by in the ISO 9001 implementation. This way, we can ensure that your business and those working for you are getting the most done in the most proficient manner and in a way that makes your business more efficient: the end result being a more profitable venture and a well-balanced, organization

 


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