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What are the R2:2013 Focus materials?

What are the R2:2013 Focus materials?

The R2:2013 standard requires recyclers to document any movement of used and end-of- life equipment that is likely to qualify as a Focus Material or hazardous waste. The R2:2013 Standard identifies as Focus Materials any end-of-life electronic equipment and/or electronic assemblies that contain hazardous materials:

A. Polychlorinated biphenyls (PCBs)
B. Mercury
C. CRT glass (with some exceptions)
D. Batteries
E. Whole or shredded circuit boards containing lead solder

In several important respects, R2:2013 adopts more detailed obligations exceeding the Basel Convention or national legislation in many countries. For example, R2:2013’s broad references to PCBs, mercury, and batteries in the definition of Focus Materials are broader than the component listings identified in the Basel Convention A1180 listing.

Also, R2:2013 removes some of the ambiguity related to the Convention’s non-hazardous waste listing for waste electronics by designating circuit boards containing lead as Focus Materials requiring more stringent management and export controls. (The Convention lists printed circuit boards under the non-hazardous B1180 waste entry in Annex IX – presumptively non- hazardous.)

R2:2013 also imposes requirements for recyclers to document the legality of importing or exporting Focus Materials contained in so-called “untested or non- functioning equipment.” As noted further below, untested used equipment destined for repair, refurbishment and reuse is generally viewed as non-waste that is outside the Basel Convention, although this issue is the subject of ongoing discussions among governments. Obligations to assess untested or end-of-life equipment containing Focus Materials apply to shipments for recycling within the Organization for Economic Co-operation and Development (OECD) area, despite the fact that the Basel Convention does not apply to such shipments, and OECD countries may not regard some of these materials as wastes subject to stringent regulation.

Furthermore, R2:2013 mandates that an electronics recycler “comply with all applicable environmental, health and safety . . . legal requirements . . .” This broad requirement ensures legal compliance includes consideration of differing approaches governments have taken to the classification and control of e-waste shipments, including imports and exports.

In conclusion, certification to R2:2013 requires recyclers to document the legality in the importing, exporting and transit countries of any movement of used and end-of- life equipment that is likely to qualify as an A1180 hazardous waste. The R2:2013 Standard’s special attention and obligations for importing and exporting Focus Materials correctly directs the attention of recyclers to those materials often regarded as “hazardous wastes” under the Basel Convention. The more general obligation to comply with applicable legal requirements ensures that in those instances where a government may choose to regulate a broader universe of used or end-of-life equipment as hazardous, such requirements are identified and addressed.

R2:2013 Regulation of Used Equipment Movement

Update: R2:2013 Regulation of Used Equipment Movement?

A multitude of governments have expressed concern over the movement of e- waste materials across country bounders for recovery under the auspices of repair or reuse.  While the approach of individual governments may vary, the Standard takes a practical approach to promoting the responsible reuse of equipment and components even as governments continue to debate the need for additional controls and transparency requirements for such shipments at the international level. R2:2013’s approach to managing used equipment for reuse is fully consistent with the requirements of the Basel Convention and establishes important documentation and assurance mechanisms that go beyond the obligations set forth in the original Convention.

  • Equipment and Components that are Fully Functional.  Tested and “fully functional” equipment that is ready for use out of the box is not subject to international waste controls under the Basel Convention.   As a treaty governing the transboundary (across country borders) movement of “hazardous waste” destined for materials recovery or final disposal, the export of functioning used equipment is clearly outside the scope of the Convention. Nonetheless, R2:2013 mandates specific testing, quality assurance and product return requirements that will reduce the risk of improper movements of end-of-life equipment and components.  These requirements apply regardless of where the equipment is managed, if it is being exported, or the country of export.
  • Equipment Tested for Key FunctionsR2:2013 Standard imposes similar requirements and documentation on proposed shipments of used products for resale that are tested for “Key Functions.” R2:2013 requires recyclers shipping equipment and components that contain Focus Materials to implement and document test methods confirming that “Key Functions” of the equipment or components are working properly, disclose to buyers the functions that are not working properly and describe the condition of the equipment, implement a Product Return Plan and policy and ensure the equipment and components meet the specifications of the recipient vendor or end user.
    • At the international level, governments have yet to adopt final guidance under the Basel Convention on the question of how the functionality of a used product is to be defined for purposes of demonstrating legitimate reuse.  The proposed definition in the pending draft Technical Guidelines on E-waste (slated for possible adoption in 2015) focuses on “essential key functions” which are defined as “the originally intended function(s) of a unit of equipment that will satisfactorily enable the equipment to be reused.”
    • This current definition in draft Basel Technical Guidelines is comparable to the current R2:2013 Standard’s focus on Key Functions: “’Key Functions’” are the originally-intended functions of a unit of equipment or component, or a subset thereof, that will satisfactorily serve the purpose(s) of someone who will use the unit.”
    • R2:2013 Standard is also in line with the approach for determining functionality reflected in the recently released European Union WEEE Recast.
  • Evaluated and Non-Functioning Equipment.  Finally, even with regard to the management of equipment that is non-functioning but suitable and intended for repair, the R2:2013 Standard again imposes documentation, tracking, recordkeeping and auditing requirements to ensure that such shipments are for legitimate repair rather than materials recovery.
    • As a rule of thumb, used equipment destined for legitimate reuse, including reuse following repair or refurbishment, does not qualify as a waste under the Convention.   While many governments support the movement of used products for legitimate repair and refurbishment as “non-wastes”, others have expressed concerns with the potential for illegal or undocumented movement of e-waste for materials recovery under the guise of repair.
    • Parties to the Basel Convention are currently negotiating whether or not to adopt a new and more expansive reading of the Convention to control certain transboundary movements of used equipment destined for repair or refurbishment, although currently there is no consensus on an approach and negotiations are expected to continue well into 2015.
    • Among the concerns raised is that new restrictions on legitimate shipments for repair could have the unintended consequence of accelerating the generation of e-waste by prematurely diverting reusable equipment to recycling rather than repair and continued use.

In summary, the Standard incorporates measures aimed at ensuring that shipments of used equipment for reuse or repair are legitimate and environmentally sound while ensuring they are practical and economically sound.

If you’d like more information about the R2:2013 standard contact us for a complimentary consultation Toll Free at

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Latest Developments in the ISO 9001 Revision Process

Latest Developments in the ISO 9001 Revision Process

June 27, 2014 – The latest developments in the ISO 9001 revision process arrived with the issue of ISO/DIS 9001. While the formal draft describes the requirements outlined in the revised version of ISO 9001 it is not the final version. However, it does give an indication on what might be included. Caution – further changes are likely before final publication of ISO 9001:2015 which is currently scheduled to be released in Q4 2015.

As previously noted – the main areas of changes proposed in ISO/DIS 9001 are:

  1. Structure and terminology, including incorporation of  Annex SL framework;
  2. The wider internal and external context of an organization’s Quality Management Systems (QMS) (Clauses 4 and 6);
  3. Detailed Quality Management System (QMS) requirements’ (broadly clauses 5 & 7 – 10)

1. Structure and Terminology: DIS adopts Annex SL, notable changes in terminology

ISO/DIS 9001 adopts the new clause structure specified in Annex SL which is now the required framework for all new and revised ISO Standards. This is to ensure that the final version of ISO 9001 is aligned and harmonized with other management systems standards. Following Annex SL structure presents QMS requirements in a more consistent, rational manner and not simply a template for elements of an organization’s QMS.

ISO/DIS 9001 contains some notable changes in the terminology used in ISO 9001:2008:

ISO 9001:2008 ISO 9001:2015 (DIS version)
‘Products’  ‘Products and services’
‘Documentation’ ‘Records’  ‘Documented information’
‘Work environment’ ‘Environment for the operation of processes’
‘Purchased product’ ‘Externally provided products and services’
‘Supplier’ ‘External provider’

In addition, there would no longer be any requirement to identify any ‘Exclusions’, i.e. QMS requirements that could not be applied due to the nature of the organizations business (clause 1.2 in ISO 9001: 2008).

2. Organizational Context: Quality Management Systems to be more externally oriented

ISO/DIS 9001 requires organizations establishing a QMS to

A.    determine relevant internal and external issues,

B.    understand the needs and expectations of interested parties,

C.    specify the scope of applicability of the Quality System

D.    consider these aspects together in order to properly understand the risks and opportunities and they present

The proposed changes in methodology require a move away from a purely inward-focusing approach to QMS development and implementation to one where external or ‘outside’ factors have a greater influence on the way in which the QMS is focused and prioritized; to be as effective as possible in meeting key internal and external objectives. An organization seeking to implement a QMS needs to determine the interested parties relevant to its QMS and their requirements.

Another important change is the adoption of a risk-based approach when developing and implementing its QMS. Organizations must identify the risks and opportunities that need to be addressed to ensure that the QMS can achieve its intended outcome(s) including those relevant to or determined by its organizational context. Organizations must plan actions to address these risks and opportunities, integrate and implement them into its QMS processes and evaluate their effectiveness.

3. Numerous changes to QMS Requirements

In addition to the adoption of a risk-based approach, there are several other new requirements:

A.    Organizations implementing a QMS must identify the necessary competence for personnel doing work that affects its quality performance, and ensure that they are competent to do so.

B.    A requirement to identify and maintain the knowledge needed to ensure the Organization achieves conformity of products and services.

C.    While ‘Preventive action’ is no longer a specific clause in ISO/DIS 9001, it is now the primary objective of a risk based QMS.

ISO/ DIS 9001 fully expects organizations to apply a process approach when planning, implementing and developing their QMS. It specifies requirements identifying the quintessential elements of such an approach, as well as the key aspects of their interaction(s).

How can Quality Resource Center HELP?

Quality Resource Center provides training to assist our clients in understanding the requirements of ISO/ DIS 9001. Quality Resource Center offers ISO 9001 Consultants and ISO Consulting Services. Quality Resource Center offers a broad array of training and certification services, as well as Internal Auditor and Auditing expertise.

FUTURE UPDATES

A copy of the ISO/DIS 9001 standard can be purchased.

The official ISO 9001:2015 working group (ISO/TC 176/SC 2) responsible for the development and publishing of the ISO 9001:2015 standard will develop a matrix showing a correlation between the clauses of ISO 9001:2008 and ISO/DIS 9001:2015.

Global Food Safety Initiative

CEOs of global companies came together at The Consumer Goods Forum (CIES at the time) and agreed that consumer trust needed to be strengthened and maintained through a safer supply chain. The Global Food Safety Initiative (GFSI) was launched as a non-profit making foundation in 2000, to achieve this through the harmonization of food safety standards that would drive reduce audit duplication throughout the supply chain by developing a model that determines equivalency between existing food safety schemes, whilst leaving flexibility and choice in the marketplace.

Today, The Global Food Safety Initiative collaborates with international food safety experts from the entire food supply chain at Technical Working Group and Stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is managed by an industry-driven GFSI Board of Directors and supported by The Consumer Goods Forum Board of Directors, with particular support from Irene Rosenfeld, Chairman and CEO, Kraft Foods and Bill McEwan, President & CEO, Sobeys Inc.

The Global Food Safety Initiative  endorses food manufacturing, distribution and agent/broker management certification by certain international organizations through the SQF Program. The SQF Program is administered by the SQF Institute (SQFI), a division of the Food Marketing Institute (FMI), and is the result of more than 15 years of development. The certification program includes two standards – SQF 1000 and SQF 2000.

SQF 1000 or “Safe Quality Food” is universally recognized by retailers and foodservice providers around the world who require a rigorous, credible food safety management system. Using the SQF 1000 certification program reduces assessment inconsistencies and costs of multiple assessment standards.

Being compliant with SQF demonstrates the supplier’s commitment to:

  • Produce safe and quality food
  • Comply with the requirements of the SQF code
  • Comply with applicable food legislation

The SQF 2000 Code is a (Hazard Analysis and Critical Control Point) HACCP-based food safety and quality management program designed primarily for the food processing and food manufacturing sector. The SQF 2000 Code is divided into three certification levels. Each level indicates the stage of development of a Supplier’s food safety and quality management system.

  • Level 1 Food Safety Fundamentals
  • Level 2 Certified HACCP Food Safety Plans
  • Level 3 Comprehensive Food Safety and Quality Management System

SQF certification is supported and in many cases mandated by an increasing number of international retailers and foodservice providers, and the SQF Program is part of a landmark agreement among seven global retailers on mutual acceptance of global food safety systems.

More Updates on ISO 9001:2015

The working draft is not yet complete. Once all of the comments receive are dispositioned, the Draft International Standard (DIS) will be released. This is expected in June or July of this year. Comments from the public will be requested in order to finalize the standard.
Several new requirements are currently in the draft, including

  1. “Products and Services” will replace “Products”.
  2. While the concept of exclusions will still apply, though the term “exclusions” will not be used.
  3. The terms “document” and “records” are being replaced by a single term “documented information”. Control for documented information will be the same as the 2008 standard.
  4. An expanded planning section will be titled “Context of the Organization” and will require companies to consider the needs of all interested parties in the design of the QMS.
  5. Much more emphasis will be placed on requirements for managing the organizations processes using the process approach and will require process owners, process inputs, process outputs and process measures.
  6. While the title of “management representative” will be dropped, the requirement for top management to appoint one or more individuals to be responsible for monitoring and reporting on the QMS will still be included.
  7. Formal “preventive action” process will be dropped, and be replace with the addition of “risk based thinking” in the planning of the QMS and new product design and development.

The intention is still to release the FDIS (final draft international standard) early next year and the published standard by the end of the year.
Regarding the Transition Period –

  1. While the transition period is expected to be 3-years, final approval on that has not been completed. That said, companies can simply transition to the new standard during their normal re-certification audit.
  2. Certification Bodies (CBs, or registrars) may start their training next year, after the FDIS is released. Because of the huge changes to the standard, the details around “what is expected by a 3rd-party auditor will take some time. Starting in 2016, CBs may start auditing to the new standard, but a lot of details will be being worked out during this first year, so there will likely be inconsistencies in these audits as everyone gets used to the new standard.
  3. Because of the big changes, most experts advise that companies retain their ISO 9001:2015 Consultants before the end of next year, thus avoiding the expected turmoil during audits to the new standard in 2016.

That’s all for now, more when information becomes available.

More Updates on ISO 14001:2015

As the release of the new Version of ISO 14001 nears, impacted organizations should start preparing themselves for the important changes that will be required. As it has been 10 years since the current Version of ISO 14001:2004 was released, it is apparent that with new release of the second Committee Draft (CD2) will bring significant changes.

As mentioned in the past, development of the new version began in early 2012 and is expected to be officially released in January 2015.

As with any new version of a standard, organizations currently certified to ISO 14001:2004 will be granted a transition period to allow for upgrade to the new standard. Quality Resource Center will release a transition guideline to all certified clients after publication of the standard.

To help organizations become familiar with the proposed upcoming changes, some of the key changes have been identified below.

The Scope shall not exclude activities, products and services within the organization’s control or influence that can have significant environmental aspects (see 6.1.4).

Structural Changes

Key Changes in Requirements

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the Organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

Additional language will require –

  • Determinations regarding how the organization will integrate its environmental management system requirements into its business processes.
  • Requiring Top Management demonstrate leadership and commitment with respect to the environmental management system
  • Organizations determine significant environmental aspects and organizational risks and opportunities by assuring the environmental management system can achieve its intended outcome(s), preventing, reducing, or eliminating undesired effects, satisfying its compliance obligations, and achieving continual improvement.
  • Actions to address significant environmental aspects, compliance obligations and organizational risks and opportunities shall be managed within the environmental management system. This must include consideration of environmental objectives and planning to achieve them (6.2.2), operational planning and control (8.1), value chain control (8.2), emergency preparedness and response (8.3), and monitoring and measurement (9.1).
  • Determinations regarding how the processes associated with its operation that are related to its significant environmental aspects and organizational risks and opportunities will be controlled or influenced, taking into account life cycle perspective.

That’s it for now….more when information becomes available.

ISO 9001:2015 – Update to “Where Are We?”

The draft version of the new ISO 9001:2015 standard has been available for some time. Somewhere around 40% of the norm will be supplemented, modified, or changed, thus this is a “major” revision.
However, the final version is not yet available.
ISO 9001:2015 Timetable
The standard is updated and I modified in phases –
Initially, multiple drafts are made distributed and made available for review and comment. Feedback from industry experts and professionals is solicited and evaluated.
The result is that the standard takes some time and effort to be revised. In specific terms this means that at present the so-called “Committee Draft” has been published as a preliminary draft. The Committee’s timetable includes publication of the final standard in September 2015.
ISO 9001:2015 Transitional Period
There is to be a three-year transitional period. During this transitional period, organizations have time to adjust their management systems to the new standard.
New ISO 9001:2015 Structure
The new standard will include new classifications. In future there will be ten clauses. One major reason for this is because the current clause 8 (Measurement, Analysis and Improvement) will be broken down into two chapters.
Summary of New ISO 9001:2015 Content
The new ISO 9001:2015 standard will include some aspects of the current ISO 9004. As a result, the standard will be modernized and adjusted to embrace certain state-of-the-art management principles.
These include the following principles:

  1. Risk Analysis and Management – a company’s risk management plays a crucial role in the new standard. It permeates nearly every clause – from corporate planning, business processes, internal audits through to supplier management. Analyzing and managing risks is further linked to opportunities for company improvement. Please note though that formal risk management (e.g. according to ISO 31000) is not mandated.
  2. Stakeholders – effective corporate management can only be realized if the needs of all of the stakeholders can be identified, quantified and included.
  3. Process approach – Process management gets its own clause in the new standard. While the Process Approach is clearly embedded in both ISO 9001:2000 and ISO 9001:2008, it much more rigorously identified, defined, and mandated in the new ISO 9001:2015 version. Thus, it no longer only relates just to recognizing the workflows in the company, but now to managing the workflows in a more specific manner as well.
  4. Documentation – Documentation will become much more flexible. Records and documents will become so-called “documented information”.
  5. Knowledge Management – The requisite expertise has to be identified, recognized, obtained, secured, and passed on internally.
  6. Leadership – Corporate management responsibilities and tasks are significantly being expanded, with a particular emphasis on the mentoring function.

What’s Next for ISO 9001:2015?
The next stage (Draft International Standard) of the ISO 9001:2015 is scheduled to be published in April 2014. It is highly probable that the content will continue to evolve and be modified.
Please continue to visit Quality Resource Center to obtain the latest updates.

ISO 14001:2015 Update – Where Are We?

ISO 14001:2004 is being revised. The International Organization for Standardization working group responsible for revising the text has already met and has produced a draft which is now being circulated for comment to its member bodies.

Since the inception of ISO 14001, more than 300,000 organizations worldwide have implemented the standard, the market-leading certification-system for environmental-management systems.  Its’ popularity is the result of the continued efforts of the committee to revise, maintain, and update the standard, keeping it current relevant ecological, political and social developments.

As the previous revision dates back several years, the International Organization for Standardization (ISO) has  announced the next version for 2015 and recently provided an insight into the changes by publishing a so-called “Committee Draft“.

The latest draft of the revised ISO 14001:2015 is being circulated to ISO’s members for comment and the working group undertaking the revision met at the end of February to address the responses to this consultation. The output from that meeting will be a “Draft International Standard”, which will undergo a full public consultation in Q2 next year, with the resulting revised published in mid-2015.

ISO 14001:2015 will have a new structure and “common text”, following new ISO guidelines for all management systems standards. Furthermore, it will address the recommendations from the ISO “Future Challenges” study for the adoption of various new approaches and methods in the field of EMS.

The Future Challenges study recommended that consideration be given in the revision of ISO 14001 to the content of ISO 26000 – Guidance on Social Responsibility, which considers the environment as the “planet” element of the “People, Planet and Profit” model. Future Challenges suggests that 14001 should address the environmental principles in ISO 26000 and also consider aligning its language.

The four environmental themes considered in ISO 26000 are:

  1. Prevention of pollution (waste and emissions);
  2. Sustainable resource use (materials, energy and water consumption);
  3. Climate change and mitigation (GHG);
  4. Protection of the environment and restoration of natural habitats (ecosystems, biodiversity, land and natural resources, urban and rural development).

More to come as Quality Resource Center has identified the major changes, and we will be publishing another in the series of soon to help you understand the key aspects of this new revision.

Understanding ISO 14001

ISO 14000 is a family of International Standards related to environmental management systems that assist organizations in –

  1. minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land);
  2. comply with applicable laws, regulations, and other environmentally oriented requirements, and
  3. continually improve in the above

 

ISO 14000 is similar to ISO 9000 quality management in that both describe the process of how a product is produced, rather than the product itself. As with ISO 9000, the certification is performed by third-party organizations rather than being awarded by ISO directly. The ISO 19011 audit standard applies when auditing for both 9000 and 14000 compliance at once.

Requirements of ISO 14001 are an integral part of the European Union‘s Eco-Management and Audit Scheme (EMAS). EMAS‘s structure and material requirements are more demanding, foremost concerning performance improvement, legal compliance and reporting duties.

The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organized a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched.  These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro, and served to generate a global commitment to the environment. In the same year, BSI Group published the world’s first environmental management systems standard, BS 7750. This created the model for the development of the ISO 14000 series in 1996 by the International Organization for Standardization.

As of 2010, ISO 14001 was in use by at least 223 149 organizations in 159 countries and economies.

Development of the ISO 14000 series

The ISO 14000 family includes most notably the ISO 14001 standard, which forms the foundation for organizations for the design and implementation of an effective environmental management system. Other standards included in this series are ISO 14004, which provides additional guidelines for good environmental management system practices. The critical objective of the ISO 14000 series of is “to promote more effective and efficient environmental management in organizations and to provide useful and usable tools – ones that are cost effective, system-based, flexible, and reflect the best organizations and the best organizational practices available for gathering, interpreting and communicating environmentally relevant information”.

Unlike previous “command and control” type environmental regulations, ISO 14000 was based on a voluntary approach to environmental regulation. The series includes the ISO 14001 standard, which provides guidelines for the establishment or improvement of an EMS. ISO 14001 shares many commonalities with its predecessor, ISO 9000, the international standard of quality management, which served as a model for its internal structure. Both standards can be implemented side by side, or as part of an integrated system. As with ISO 9000, ISO 14000 acts both as an internal management tool as well as a mechanism for demonstrating a company’s environmental commitment to its customers and clients.

Prior to the development of the ISO 14000 series, organizations opted to voluntarily design and develop their own EMS systems. However, this made comparisons of environmental effects between companies challenging, and therefore the ISO 14000 series was developed.

An EMS is defined by ISO as: “part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving and maintaining the environmental policy”.

 

ISO 13485 – Standards for Medical Devices

ISO 13485:2003 is an International Organization for Standardization (ISO) standard, published in 2003, that sets forth the requirements for a comprehensive quality management system developed for the design, marketing, manufacture, and service of medical devices.

The standard supersedes previous documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

While it is tailored to the industry’s quality system expectations and regulatory requirements, an organization need not be actively engaged in the manufacturing of medical devices or their components to seek certification to this standard.

Although it is a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. One significant difference is that while ISO 9001 requires the organization to demonstrate continual improvement, ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Furthermore, the ISO 9001 requirements regarding customer satisfaction are not included in the medical device standard.

Other specific differences include:

a)     the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union

b)     controls in the work environment to ensure product safety

c)      focus on risk management activities and design control activities during product development

d)     specific requirements for inspection and traceability for implantable devices

e)     specific requirements for documentation and validation of processes for sterile medical devices

f)      specific requirements for verification of the effectiveness of corrective and preventive actions

Some see that compliance with ISO 13485 is often seen as the first step in achieving compliance with certain European regulatory requirements. For example, the conformity of Medical Devices and In-vitro Diagnostic Medical Devices 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. A result of the positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.

ISO 13485 is now considered to be in line with standards and requirements for medical devices including the “Global Harmonization Task Force Guidelines” (GHTF). The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices.