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Assisting Organizations in Quality Improvement Since 1993

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ISO 9001:2015

Unlike ISO 9001:2008 revision which was primarily semantic changes, the 2015 revision seems to include some major changes similar to transition from 1994 to 2000 edition. The release of the new 2015 standard probably will not happen until later 2015 or early 2016, but it is worth while to take a look at the proposed changes and try to incorporate some of the changes into revisions of existing ISO 9001:2008 program in preparation to the new standard and also for continual improvement.
Please note that the changes in the draft document is subject to change and the released document may include some major differences to the proposed draft.

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633

Health Canada, Medical Device Single Audit Program (MDSAP)

Starting January 2014 Health Canada will be participating in a pilot program by launching the Medical Device Single Audit Program (MDSAP)together with the Australian Therapeutic Goods Administration of Australia (TGA), the Brazilian Nacional de vigilancia sanitaria (ANVISA) and United States Food and Drug Administration (FDA).
This program is intended to provide similar assessment system as the current (CMDCAS) which has been adopted by Health Canada for number of years now.
Health Canada will continue to operate the current (CMDCAS) as well as the new (MDSAP) for period of three year pilot program. During the pilot the certificates generated by registrars under MDSAP will be used instead of (CMDCAS) until the three year pilot which and successful completion of the pilot the (MDSAP) will replace the (CMDCAS), and (CMDCAS) will no longer will be used for assessment of the quality systems.
Under this program the manufacturers will benefit from a single audit program that meets the requirements of multiple countries. This will reduce the number of inspections faced by medical device manufacturers which a present cause significant disruption and cost to business operations while at the same time maintaining appropriate regulatory oversight.

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap_pilot_notice_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap_pilot_inter_coal_avis-eng.php

FDA Video Presentation on MDSAP:
http://fda.yorkcast.com/webcast/Viewer/?peid=ae40c79d2479493393241d4a90e586691d

FDA Slide Presentation MDSAP:
http://www.fda.gov/downloads/Training/CDRHLearn/UCM372920.pdf

What’s new in Health Canada Regulations

Health Canada has made substantial changes to Medical Device Regulations and supporting guidance documents that should be considered by organizations that are involved with medical devices in form of Medical Device Establishment License (MDEL) or Medical Device License (MDL).
These changes include:
– September 21, 2011 – Medical Device Regulations MDR
– October 3, 2011 – Guidance Document for Mandatory Problem Reporting for Medical Devices – Canada Vigilance Medical Device Problem Reporting.
– March 25, 2011 – Guide to Recall of Medical Devices – GUI-0054
– March 25, 2011 – Guidance on Investigation of Reported Medical Devices Problems – GUI-0065
– October 1, 2010 – Guidance on Risk Classification of Medical Devices Observations – GUI-0079
– April 1, 2011 – Guidance Document for the Interpretation of Significant Change
For other Health Canada Guidance documents visit:
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php#guidance_devices

Seven deadly sins of implementing ISO 9001

The Quality Management Standards including ISO 9001, are excellent standards for management of quality, however, there are many who express their concerns towards the idea of having a documented quality management system.
Based on my experience in working with many organizations the following need to be avoided in establishing a quality management system, to enable you to maintain a dynamic system that helps your organization to grow and continually improve

The following are some examples of why companies fail to reap the benefits of ISO 9001 program:
1. Lack of management understanding and support of the QMS;
2. Neglecting the Quality Policy Statement and asking the staff to memorize it;
3. Lack of experience and desire of the Management Representative, assigned to oversee the system;
Note: Whether the Management Representative is the quality manager or someone assigned to carry out the task, she or he must have the experience and be willing to continually hone their skills to manage the QMS.
4. Use of generic design for the quality management system that is foreign to your organization;
5. Assuming that you have to implement certain tasks because the ISO 9001 standard requires it;
Note: if the consultant or other individuals in charge of your QMS program development tells you that you must do this task because it is required,  I am afraid that the suggested program is not for you. The consultant must be able to convince you that this task is important for maintaining your QMS and, you have to be convinced.
6. Creating a QMS that runs in parallel to your daily activities, without being part of your system, for the purpose of maintaining registration;
Note: your quality management system must become part of your daily activities and not a burden to slow down your work.
7. Over documentation and maintaining too many paper records, which are purely kept for presentation to auditors, with no added value.

Paperless QMS

If you quality management system is still based on paper records, or combination of paper and spreadsheets, and your quality manager has piles of unfiled records waiting for review, analysis and filing, I have to tell you that your QMS is obsolete and you are not running an efficient cost effective system.
Due to advances in technology, there are many tools available that can be used to facilitate this transition. Small and medium size companies can take advantage of simpler, more available databases such as MS Access which is available with most Office Suites at reasonable price.
Alternatively you can set your quality management database on Intranet or more elaborate systems that can be integrated with your ERP or other systems.
Whether your quality management system is based on ISO 9001, ISO 13485, ISO 14001 or other management systems, it is paramount for the efficiency of your quality management system to maintain the following records electronically:
– Nonconformance/Corrective Preventive Actions
– Training records
– Calibration records
– Engineering change records
– Audit records
– Management review records
– Receiving records
Using readily available technology will enable you to maintain a dashboard to readily analyze data and evaluate trends for continual improvement.
If you wish to have an evaluation done on the efficiency of your Quality Management System, we can certainly help you in transfer of your paper based system to an efficient database system suited for your organization.

IEC 60601-1 Edition 3

Medical Electrical Device (MED) companies are required to adopt IEC 60601-1 edition 3 in 2012.  The timeline to adopt to the new standard is as follows:

Europe: June 1, 2012
Canada: June 1, 2012
USA: July 1, 2013

This standard requires more in depth Risk Analysis, consistent with ISO 14971:2007 requirements covering product lifecycle in addition to re-testing the device to 60601-1 edition 3. The Risk Management Audit part of the compliance consists of full review of implementation of ISO 14971 which requires addressing all elements as required by this standard.

The following steps need to be taken to comply with 60601-1 edition 3:

  • Familiarize yourself with the standard
  • Revise your Risk Management File to ensure it is consistent with ISO 14979:2007
  • Update your design file to cover risk management requirements
  • Retest the device to IEC 60601-1 edition 3

Patient Management Software

As of September 1, 2011, Manufacturers, importers and distributors of medical device software and facilities that purchase patient management software must comply with Health Canada Medical Device Regulations, including the requirement for a valid ISO 13485 (CMDCAS) Quaity System Certification. Any changes made to the device must be consistent with paragraph 34 of Health Canada Medical Device Regulations.
It is therefore important for your organization to ensure that your Patient Management Software is licensed for sale or use within Canada.

Licensing Medical Devices in Canada

Class I: Manufacturers, importers or distributors of a Class I medical device selling directly (not through distributor) need to secure a Medical Device Establishment License (MDEL). Form – 0292 is used for MDEL application.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/licences/form/frm-0292-eng.pdf
Class II, III & IV: Manufacturers, importers or distributors of Class II, Class III and Class IV must secure a Medical Device License (MDL).
Certification of the quality management system to ISO 13485 and CMDCAS is required for all organizations seeking MDL for all medical devices sold in Canada.
To apply for Class II the following form must be submitted to HC:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/licapp_demhom_cla2-eng.pdf

For class III and IV the procedure is more complicated and must be addressed on a case by case situation, the scope of documentation is similar to 510k clearance.
Private Label: If you wish to private label a medical device you need to comply with HC regulations for Private Labelling:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/label_marque_pri-eng.pdf

Private label manufacturers must apply for and obtain a medical device licence (MDL) in order to sell their Class II, III or IV private label medical devices in Canada.

ISO 9004:2009

If your company has been registered for number of years and you would like to improve your quality management system further, perhaps you should consider implementation of ISO 9004:2009.
The ISO 9004 series have always been used hand in hand with, and as an implementation guide to ISO 9001, but since the 2009 edition, the ISO 9004 has had the life of its own. ISO 9004:2009 in addition to being an excellent guide to implementation of quality management system is also a full-fledged standard that can be implemented on its own.
By looking at the body of ISO 9004:2009 it is evident the direction that the standard is taking, by inclusion of the following, in addition to provide guidance on enhancement of ISO 9001 standard:
– Sustained success
– Strategy and policy formulation
– Strategy and policy deployment
– Strategy and policy communication
– Financial resources
– Natural resources
– Improvement innovation and learning
Looking at the above additions it is evident that the overall policy of the organization has to expand beyond the broad policies that are commonly adopted under quality or environmental management systems.
The ISO 9004:2009 might be a good fit for your organization if you would prefer to pursue the excellence model within your organization.
At this point in time there is no certification for this standard, but you never know.

Lean manufacturing and what it means to you

A philosophy of production that emphasizes the minimization of the amount of all the resources (including time) used in the various activities of the enterprise. It involves identifying and eliminating non-value-adding activities in design, production, supply chain management, and dealing with the customers. Lean producers employ teams of multi-skilled workers at all levels of the organization and use highly flexible, increasingly automated machines to produce volumes of products in potentially enormous variety. It contains a set of principles and practices to reduce cost through the relentless removal of waste and through the simplification of all manufacturing and support processes. (Source: http://www.apics.org/)

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