1. Health Canada Iso 13485

First off: ISO is an evolution of the previous versions having barely been altered since ISO – not a revolution. However, a variety of small changes even affecting chapter structure makes it necessary to deal with this latest version of the standard intensely. Chapter 1The new standard specifies that it explicitly also applies to outsourced processes.

There must not be a black hole within the value-added chain.It is also explicitly included that regulatory requirements shall additionally be regarded as well as risk management. The demand of meeting regulatory requirements was already existent in Chapter 7.1. This no longer exclusively applies to development. Chapter 3A new term, namely the medical device family, allows for providing evidence not only on the level of a product, but also on the level of a medical device family. For example, risk management could be carried out only once for very similar devices belonging to one family instead of carrying it out redundantly for each individual family member.

Chapter 4: What used to be rather ensconced in Chapter 8 is now explicitly expressed in Chapter 4.1 of ISO: Software used in a quality management systems must be validated. An example would be software to manage customer feedback. This requirement is no longer limited to production and service provision. Chapter 5From now on, the management review (chapter 5.6) must additionally consider:. Input: complaint handling, notifications to authorities and measurement of products and processes.

Output: suitability and adequacy of the QM-systemChapter 7Risk management can, but must not be compliant with ISO 14971.Chapter 7.3's structure has been revised in ISO. New are the demands for documenting ' procedures for design and development', including design transfer. Here, again, the FDA's influence becomes noticeable.According to chapter 7.3.8, this design transfer would ideally be carried out after verification, but prior to validation, for example to validate products of pilot series.Also new is chapter 7.3.10, design and development files, corresponding to the FDA's Design History File.Chapter 7.5.6 on process validation requires more precisely that relevant process' software shall be validated. Chapter 8Two new subchapters have been incorporated into the new version of ISO 13485:.

chapter 8.2.2 addresses complaint handling more detailed. chapter 8.2.3 addresses the communication with authorities and notified bodiesThe analysis of data (chapter 8.4) now must explicitly consider results of audits and service reports (as appropriate). ISO: Good or bad? A Conclusion Things are getting easierBetter interplay with 21 CFR part 820: ISO now better covers requirements of 21 CFR part 820. Companies exporting to the USA should therefore already partly meet the requirements.Better coverage of MDD: ISO 13485 only partly covered requirements for a quality management system by directives such as the MDD.

With the new version of 2016, the coverage ratio is increasing, for example regarding communication with authorities. Annexes ZA to ZC illustrate that mapping. ChallengesDivergence 9001 and 13485: the two standards ISO 13485 and ISO 9001 diverge regarding their 2015 and 2016 version respectively.

Health Canada Iso 13485

Mapping becomes increasingly difficult; also, because the high level chapter structures are no longer congruent. A mapping table in the annex to ISO is not estimated to be error-free. Time LineISO was submitted as FDIS in October 2015.The standard was issued in March 2016. DIN EN  followed in August 2016.The transition period of the old ISO 13485 is terminating in November 2019. However, EN ISO names March 2019. Though relevant is the DaKKS’s estimation: it refers to 31 March 2019 (update January 2018).A harmonization of ISO regarding the Medical Device Directive (MDD) and In-Vitro Diagnostic Directive took place in December 2017.

It is still open until when the standard will be harmonized to the Medical Device Regulation (MDR).The accreditation of notified bodies has partly happened as late as mid of 2017.If ISO 13485 will follow the structure of ISO 9001 in the long term is not yet clear and still lies ahead, anyway. Tips on Transitioning to the 2016 Version of ISO 13485The following tips are useful for a successful transition to the new version of ISO 13485:.

Talk to your notified body about when you will transition to the new standard. Make a gap analysis and assess the efforts to upgrade your QM system. Johner Institute can help you fast and effectively. Draw up a plan on when you will implement which (new) requirement. Do not make use of some freedoms ISO 9001:2015 would offer you, such as foregoing a QM manual.

Watch out for suppliers only 'certified' according to ISO 9001 to operate in compliance with the rules of your(!) QM system, if required. Plan a mock-up audit to assess the readiness for your next certification audit and to avoid any unforeseen problems.

This standard will soon be the harmonized standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices). However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system.The ChangesThe scope, terminology and the requirements contained in sections 4 to 8 of EN ISO are exactly the same as those in ISO. Thefore the ISO 13485 audit criteria being assessed by a certification body or Notified Body have not changed.The section that has been changed is the Foreword and in particular Annex ZA, Annex ZB and Annex ZC. These annexes link the clauses in ISO with the requirements of the conformity assessment annexes of Directives 90/395/EEC, 93/42/EEC and 98/79/EC respectively. What these annexes now make clear is that the Directives have requirements which must be met by manufacturers in addition to meeting all the generic requirements in ISO 13485.CertificatesAs the requirements of ISO 13485 have not changed, certificates issued against ISO will remain valid and no change in any certificate is strictly necessary. However for some time SGS has been indicating both ISO the international version and EN ISO + AC 2009 the European harmonized version on all their UKAS accredited certificates. So when EN ISO is officially harmonized (expected before the end of 2012) SGS will start to reference ISO and EN ISO on all new or amended certificates.

The reference to ISO 13485 on CMDCAS certificates will not change as this scheme is based only on ISO. It is expected that other Notified Bodies will take similar action on certificates.HarmonizationManufacturers can check the progress of the harmonization of this standard on the.