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ISO 13485: Quality Management Systems for Medical Devices

IQA – Portland, Oregon ISO 13485 Standards Training & Consultant Company

Worth noting is that for ISO conformance,documentation is not the objective, it is a means to an end. Proof: read ISO 9001: 2008 and notice it requires only 8 documented procedures, which by the way are not related to the design, manufacturing and testing of products or services.

To focus onfor ISO and to be a lot more effective than most organizations:

  1. Demonstration of process control at all levels of the organization:
    • Use of key performance indicators (KPIs) can be helpful here. Include KPIs for processes such as corrective and preventive action, internal and external audits etc,
    • If your process is under control you have the right mix of competency, documentation, instrumentation, materials etc. You should however remain vigilant for identification of opportunities for improvement.
  2. Team work instead of well intended solo activities:
    • Corrective and preventive actions shall be addressed by a team rather than by a quality manager. These actions bring the largest opportunity for improvement and should be taken seriously. A brief weekly meeting between managers from the various departments can greatly improve root cause analysis and this enhance the effectiveness of the solutions provided.
  3. For any problem, devise a solution and an alternative solution

Committees wrote these ISO standards, and although common-sense and non-bureaucratic in nature, they are not easy to understand without some guidance.

We will be happy to put you on the right track. Contact IQA by phone: 503 522 9456, or you can Email Us.


More About ISO 13485 Standards (Source: Wikipedia)

A good source of information is the ISO website:
http://www.iso.org/iso/about/discover-iso_isos-name.htm

High level information regarding these standards is available through Wikipedia:
http://en.wikipedia.org/wiki/ISO_14000

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 [1][clarification needed]. 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 continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Other specific differences include:

  • 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.

This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.

ISO 9000 9001 Standards: Quality Management Systems

IQA – Portland, Oregon ISO 9000 / 9001 Standards Training & Consultant Company

Worth noting is that for ISO conformance,documentation is not the objective, it is a means to an end. Proof: read ISO 9001: 2008 and notice it requires only 8 documented procedures, which by the way are not related to the design, manufacturing and testing of products or services.

To focus onfor ISO and to be a lot more effective than most organizations:

  1. Demonstration of process control at all levels of the organization:
    • Use of key performance indicators (KPIs) can be helpful here. Include KPIs for processes such as corrective and preventive action, internal and external audits etc,
    • If your process is under control you have the right mix of competency, documentation, instrumentation, materials etc. You should however remain vigilant for identification of opportunities for improvement.
  2. Team work instead of well intended solo activities:
    • Corrective and preventive actions shall be addressed by a team rather than by a quality manager. These actions bring the largest opportunity for improvement and should be taken seriously. A brief weekly meeting between managers from the various departments can greatly improve root cause analysis and this enhance the effectiveness of the solutions provided.
  3. For any problem, devise a solution and an alternative solution

Committees wrote these ISO standards, and although common-sense and non-bureaucratic in nature, they are not easy to understand without some guidance.

We will be happy to put you on the right track. Contact IQA by phone: 503 522 9456, or you can Email Us.


More About ISO 9000 / 9001 (Source: Wikipedia)

A good source of information is the ISO website:
http://www.iso.org/iso/about/discover-iso_isos-name.htm

High level information regarding these standards is available through Wikipedia:
http://en.wikipedia.org/wiki/ISO_14000

ISO 9001 standard

The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002). The standards are published by ISO, the International Organization for Standardization and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems (Tsim et al, 2002), including the eight management principles (Beattie and Sohal, 1999; Tsim et al, 2002) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.

Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.

Reasons for use

The ISO family of standards is the only international standard that addresses systemic change, the idea of system change is best summarized by W.E. Deming, the holistic transformation of the organization is the single most important factor and is often overlooked. The global adoption of ISO 9001 may be attributable to a number of factors. A number of major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders’ benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with a 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business. Corbett et al (2005) showed that certified organizations achieved superior return on assets compared to otherwise similar organizations without certification. Heras et al (2002) found similarly superior performance [9] and demonstrated that this was statistically significant and not a function of organization size. Naveh and Marcus (2007) showed that implementing ISO 9001 led to superior operational performance. Sharma (2005) identified similar improvements in operating performance and linked this to superior financial performance. Chow-Chua et al (2002) showed better overall financial performance was achieved for companies in Denmark. Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.

While the connection between superior financial performance and ISO 9001 may be seen from the above, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al (2005) may suggest it. Other writers such as Heras et al (2002) have suggested that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.

The mechanism for improving results has also been the subject of much research. Lo et al (2007) identified operational improvements (cycle time reduction, inventory reductions, etc.) as following from certification. Buttle (1997) and Santos (2002) both indicated internal process improvements in organizations leading to externally observable improvements. Hendricks and Singhal (2001) results indicate that firms outperform their control group during the post implementation period and effective implementation of total quality management principles and philosophies leads to significant wealth creation. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment according to Alcorn.

Background

ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979. Its history can however be traced back some twenty years before that when the Department of Defense published its MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into being the BS 5750 series of requirements standards in 1979, before being submitted to ISO.

BSI has been certifying organizations for their quality management systems since 1978. Its first certification (FM 00001) is still extant and held by the Tarmac company, a successor to the original company which held this certificate. Today BSI claims to certify organizations at nearly 70,000 sites globally.

ISO 14000 14001 Standards: Environmental Management

IQA – Portland, Oregon ISO 14001 Standards Training & Consultant Company

Worth noting is that for ISO conformance,documentation is not the objective, it is a means to an end. Proof: read ISO 9001: 2008 and notice it requires only 8 documented procedures, which by the way are not related to the design, manufacturing and testing of products or services.

To focus onfor ISO and to be a lot more effective than most organizations:

  1. Demonstration of process control at all levels of the organization:
    • Use of key performance indicators (KPIs) can be helpful here. Include KPIs for processes such as corrective and preventive action, internal and external audits etc,
    • If your process is under control you have the right mix of competency, documentation, instrumentation, materials etc. You should however remain vigilant for identification of opportunities for improvement.
  2. Team work instead of well intended solo activities:
    • Corrective and preventive actions shall be addressed by a team rather than by a quality manager. These actions bring the largest opportunity for improvement and should be taken seriously. A brief weekly meeting between managers from the various departments can greatly improve root cause analysis and this enhance the effectiveness of the solutions provided.
  3. For any problem, devise a solution and an alternative solution

Committees wrote these ISO standards, and although common-sense and non-bureaucratic in nature, they are not easy to understand without some guidance.

We will be happy to put you on the right track. Contact IQA by phone: 503 522 9456, or you can Email Us.


More About ISO 14000 / 14001 (Source: Wikipedia)

A good source of information is the ISO website:
http://www.iso.org/iso/about/discover-iso_isos-name.htm

High level information regarding these standards is available through Wikipedia:
http://en.wikipedia.org/wiki/ISO_14000

ISO 14001 standard

The standard is not an environmental management system as such and therefore does not dictate absolute environmental performance requirements (National Academy Press 1999), but serves instead as a framework to assist organizations in developing their own environmental management system (RMIT University). ISO 14001 can be integrated with other management functions and assists companies in meeting their environmental and economic goals.

ISO 14001, as with other ISO 14000 standards, is voluntary (IISD 2010), with its main aim to assist companies in continually improving their environmental performance, whilst complying with any applicable legislation. Organizations are responsible for setting their own targets and performance measures, with the standard serving to assist them in meeting objectives and goals and the subsequent monitoring and measurement of these (IISD 2010). This means that two organizations that have completely different measures and standards of environmental performance, can both comply with ISO 14001 requirements (Federal Facilities Council Report 1999).

The standard can be applied to a variety of levels in the business, from organizational level, right down to the product and service level (RMIT university). Rather than focusing on exact measures and goals of environmental performance, the standard highlights what an organization needs to do to meet these goals (IISD 2010). Success of the system is very dependant on commitment from all levels of the organization, especially top management (Standards Australia/Standards New Zealand 2004), who need to be actively involved in the development, implementation and maintenance of the environmental management system (iso14001.com.au 2010). In 2008 there were an estimated 188 000 companies from 155 countries, certified as ISO 14001 compliant (ISO14001.com.au 2010)

ISO 14001 is known as a generic management system standard, meaning that it is applicable to any size and type of organisation, product or service, in any sector of activity and can accommodate diverse socio-cultural and geographic conditions (Standards Australia/Standards New Zealand 2004). All standards are periodically reviewed by ISO and new ones issued (Standards Australia/Standards New Zealand 2004).

Basic principles and methodology

The fundamental principle and overall goal of the ISO 14001 standard, is the concept of continual improvement (Federal Facilities Council Report 1999). ISO 14001 is based on the Plan-Do-Check-Act methodology (Standards Australia/Standards New Zealand 2004) which has been expanded to include 17 elements, grouped into five phases that relate to Plan-Do-Check-Act; Environmental Policy, Planning, Implementation & Operation, Checking & Corrective Action and lastly Management Review (Martin 1998).
Prior to implementing ISO 14001, an initial review or gap analysis of the organisation’s processes and products is recommended, to assist in identifying all elements of the current operation and if possible future operations, that may interact with the environment, termed environmental aspects (Martin 1998). Environmental aspects can include both direct, such as those used during manufacturing and indirect, such as raw materials (Martin 1998). This review assists the organisation in establishing their environmental objectives, goals and targets, which should ideally be measurable; helps with the development of control and management procedures and processes and serves to highlight any relevant legal requirements, which can then be built into the policy (Standards Australia/Standards New Zealand 2004).

Do – implement the processes

During this stage the organization identifies the resources required and works out those members of the organisation responsible for the EMS’ implementation and control (Martin 1998). This includes documentation of all procedures and processes; including operational and documentation control, the establishment of emergency procedures and responses, and the education of employees, to ensure they can competently implement the necessary processes and record results (Standards Australia/Standards New Zealand 2004). Communication and participation across all levels of the organisation, especially top management is a vital part of the implementation phase, with the effectiveness of the EMS being dependant on active involvement from all employees (Federal Facilities Council Report 1999).

Check – measure and monitor the processes and report results

During the check stage, performance is monitored and periodically measured to ensure that the organisation’s environmental targets and objectives are being met (Martin 1998). In addition, internal audits are regularly conducted to ascertain whether the EMS itself is being implemented properly and whether the processes and procedures are being adequately maintained and monitored (Standards Australia/Standards New Zealand 2004).

Act – take action to improve performance of EMS based on results

After the checking stage, a regular planned management review is conducted to ensure that the objectives of the EMS are being met, the extent to which they are being met, that communications are being appropriately managed and to evaluate changing circumstances, such as legal requirements, in order to make recommendations for further improvement of the system (Standards Australia/Standards New Zealand 2004). These recommendations are then fed back into the planning stage to be implemented into the EMS moving forward.

Continual Improvement Process

The core requirement of a continual improvement process (CIP) is different from the one known from quality management systems. CIP in ISO 14001 has three dimensions (Gastl, 2009):

Overall, the CIP-concept expects the organization to gradually move away from merely operational environmental measures towards a strategic approach on how to deal with environmental challenges.

Benefits

ISO 14001 was developed primarily to assist companies in reducing their environmental impact, but in addition to an improvement in environmental standards and performance, organizations can reap a number of economic benefits including higher conformance with legislative and regulatory requirements (Sheldon 1997) by utilizing the ISO standard. Firstly by minimizing the risk of regulatory and environmental liability fines and improving an organization’s efficiency (Delmas 2001), leading to a reduction in waste and consumption of resources, operating costs can be reduced (ISO14001.com.au 2010). Secondly, as an internationally recognized standard, businesses operating in multiple locations across the globe can register as ISO 14001 compliant, eliminating the need for multiple registrations or certifications (Hutchens 2010). Thirdly there has been a push in the last decade by consumers, for companies to adopt stricter environmental regulations, making the incorporation of ISO 14001 a greater necessity for the long term viability of businesses (Delmas & Montiel 2009) and providing them with a competitive advantage against companies that do not adopt the standard (Potoki & Prakash, 2005). This in turn can have a positive impact on a company’s asset value (Van der Deldt, 1997) and can lead to improved public perceptions of the business, placing them in a better position to operate in the international marketplace (Potoki & Prakash 1997; Sheldon 1997). Finally it can serve to reduce trade barriers between registered businesses (Van der Deldt, 1997).

Organizations can significantly benefit from EMS implementation through the identification of large cleaner production projects (e.g. which can drastically cut electricity costs in manufacturing industries). ISO 14001 can be a very effective tool to identify these cost savings opportunities for some organizations. Some other organizations can falter in its planning, lack of senior management commitment and poor understanding of how it should be implemented and find themselves managing an ineffective EMS. Improvements that organizations can make include adequately planning their structure and allocating adequate resources, providing training, creating forums for discussion, setting measurable targets and working according to the philosophy of continuous improvement (Burden, 2010).

Conformity Assessment

ISO 14001 can be used in whole or in part to help an organization, for profit or not-for-profit, better manage its relationship with the environment. If all the elements of ISO 14001 are incorporated into the management process, the organization may opt to prove that it has achieved full alignment or conformity with the international standard, ISO 14001, by using one of four recognized options. These are:

  • Option 1 is sometimes incorrectly referred to as ‘self-certify” or “self-certification”. This is not an acceptable reference under ISO terms and definitions, for it can lead to confusion in the market (Reference: ISO/IEC 17000:2004(E/F/R)).
  • Option 2 is often referred to as a customer or 2nd party audit, which is an acceptable market term.
  • Option 3 is an independent third-party process that is based on the EnviroReady Report, which is the proprietary name for a service provided by specially trained professional accountants. The training process for accountants is managed by 14000registry.com. It is categorized by ISO as a recognition scheme. It was designed to assist small and medium-sized enterprise, but can be used by any entity.
  • Option 4, certification, is another independent third-party process, which tends to be used by large firms. Certification is also known in some markets as registration. Service providers of certification or registration are accredited by national standards bodies; these service providers are usually listed on the website of the national standards body.

ISO 14001 Consultancy

ISO 14001 relates to environmental issues. Although it is a system standard, it requires an organization to identify and assess environmental aspects and take necessary control to reduce environmental impacts. Many organizations need to put efforts into taking on additional environmental tasks so they employ ISO 14001 consultancy firms to solve the technical environmental issues. Training is the first step in implementing ISO 14001. Organizations may then consider ISO 14001 consultancy.

 

Peter Kloosterman Bio

Peter Kloosterman was born and raised in the Netherlands and graduated with an MSEE from Delft University of Technology in 1980.

Worked as a systems programmer and later on as the Technical Support manager of Philips Semi-Conductors in the Netherlands (Nijmegen). Recognized the importance of quality from  the IT customers’ point of view: unplanned downtime is unacceptable and a 5 minute reboot can set the factory hours and thousands of dollars back. Changes to the IT environment shall be planned and controlled, and applications and services shall be transparent to the end user.

Joined KEMA (now DEKRA), a leading Dutch Registrar and Notified Body in early 1990 and quickly became a  lead auditor for high tech industries. Also active as certification manager, heavily involved in bringing the polish subsidiary up to speed, and trained in the MDD directive by one of the most experienced man around at the time.

Relocated to the US in 1998 and after a brief stint with PFS joined IQA as a Sr. Consultant in 2000. Took over the company in 2007 from its remaining founder.

His approach to ISO management standards is that they are common-sense and non-bureaucratic. Any bureaucracy in a QMS or EMS is created by the company, not by the standard! Peter is for good reason a long time advocate of requiring management experience from external auditors. He does not subscribe to the common notion that more product or process documentation leads to improvement, and he is keenly aware that many quality and environmental management systems (certified or not) add no value nor reduce a risk (for non-believers: check the FDA recall site).

As the principal of IQA his philosophy is simple: 1. do the right things right (question as needed everything), 2. get the best (wo)man for the job, 3. keep the cost low, 4. Repeat.

Peter and IQA provides auditing, consulting, training and interim management services for:

For more information email info@iqa.com, or call 503 522 9456.