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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.

 

R2:2013 Responsible Recycling of Electronic Waste Transition

On April 30, 2013, the R2 Solutions Board of Directors established the requirements for the transition to

R2:2013. In addition to the new R2:2013 Standard, a new R2 Code of Practice has been released, governing the implementation of all matters relating to the R2:2013 Standard and an R2 guidance document which clarifies the intent of requirements of the R2:2013 Standard.

R2:2013 was created to clarify requirements of the R2:2008 practices, improve the readability and understanding of the standard, provide additional best practices and improve the quality of certification.

The new revision was effective as of July 1, 2013.

It is not intended to serve as a standalone Environmental Health and Safety Management System, and requires a company to possess certification to ISO 14001 and OHSAS 18001, or RIOS.

Certification Bodies will no longer conduct registration audits to the R2:2008 beginning six months after the effective date of R2:2013, January 1, 2014.

Renewals of existing certificates shall be based on conformance to R2:2013 prior to the end of the eighteen month transition period.

Existing R2:2008 certifications will no longer be valid eighteen (18) months after the effective date of July 1, 2013 for R2:2013.

Also effective July 1, 2013 all facilities must, per the R2 Code of Practices, have a Licensing Agreement in place with R2 Solution. They must pay their licensing fee to R2 Solutions at the time of surveillance, certification or recertification audit to either R2:2008 or R2:2013.

 

Each client is responsible for completing an application form and paying an online fee.

For multi-site facilities, each site must have its own License Acknowledgment receipt issued.

To obtain and maintain a licensing agreement with R2 Solutions, a company must:

a)     Engage in electronic reuse and recycling activities such as collecting, refurbishing, reselling, processing, demanufacturing, recovering assets,

b)     brokering of electronics equipment or components

c)     Abide by all requirements relating to use of the use of the R2 logo

d)     Remain current in its payments to R2 Solutions for the licensing fee.

e)     Otherwise conform to the licensing agreement

 

In issuing certifications and notification to R2 Solutions the following items have been identified as areas of compliance

a)     The CB must verify that the certification candidate’s with R2 Solutions is current during any audits.

b)     Multi-site certifications must clearly identify the controlling site.

c)     Each site listing will clearly demonstrate any differences in scope of activities between sites.

d)     Each site must be fully audited before added to the multi-site certificate.

e)     Campus certifications shall clearly identify the main processing location and follow any applicable requirements within the R2 code of practices.

f)      If any allowances are used, each allowance will be documented on the certificate. Allowances do not change the requirements of the R2 Standard, they remove a requirement from the scope of certification for certain types of organizations. Examples include broker allowances, co-location allowances, campus allowances, and focus material processor allowances.

 

The R2 Code of Practice includes some interesting changes regarding the calculation of audit time.

a)     The number of downstream vendors and their R2 certification status will affect the duration of an organization’s audit.

b)     In addition, accredited certification bodies are now required to add time to each audit to verify nonconformities from the prior audit.

c)     In addition, multi-site certifications are now allowed at initial certification, provided there is one EH&S management system and shared documented Processes; however, as part of the initial audit all members of the multi-site must be audited.

d)     Sampling can be performed on subsequent surveillance audits.

Lastly, the R2 Code of Practice details stringent requirements relating to suspension of certificates. Suspension may result for a number of reasons including, an organization knowingly selling and misrepresenting non-functioning equipment to customers. It includes organizations doing this under an associated/related e-Bay presence, even if operating under a different name or alias.

Certificates may also be suspended if an organization misrepresents the certification status of any facilities associated with the organization.

 

ISO 9001:2015 – Where Are We?

ISO 9001 is currently undergoing its’ first major revision in nearly 15 years. It’s an exciting time in the Quality world.

According to the draft design specification, the revised ISO 9001:2015 standard should (among other things):

  • Provide a stable core set of requirements for the next 10 years or more
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

The revised Standard has significantly upgraded the clause structure as follows:

  • Clause 1 – Scope
  • Clause 2 – Normative references
  • Clause 3 – Terms and definitions
  • Clause 4 – Context of the organization
  • Clause 5 – Leadership
  • Clause 6 – Planning
  • Clause 7 – Support
  • Clause 8 – Operation
  • Clause 9 – Performance evaluation
  • Clause 10 – Improvement

 

Timeline

timeline-picture

Per Nigel H. Croft – Chair – ISO/TC 176/SC 2, Quality systems

 

Significant Changes in ISO 9001 Revision 2015 Committee Draft

1. The term “product” has been replaced by “goods and services”.

2. Two new clauses related to the context of the organization:

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties.

3. The requirement to use the process approach has been more explicit by adding a new clause.

4.4.2 Process approach

4. The standard does not include a specific clause for “Preventive Actions”.

5. The terms “document” and “records” have been replaced with the term “documented information”.

6. Control of external provision of goods and services address all forms of external provisions.

7. The term “continual improvement” has been replaced with “improvement”.

 

That is quite significant.

 

More to come in our next BLOG…

 

11/15/2013

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