A few weeks ago, I issued a poll on LinkedIn to my connections and followers on topics they would like to see feature in the Comply Guru Blog Series.<\/p>\n
Imagine my surprise when the majority vote went to Training and Competence, or as us Quality Folks know it, Clause 6.2 of ISO 13485 (2016) – Human Resources, a sub clause of Clause 6 \u2013 Resource Management.<\/p>\n
Yes, you read that right, Resource Management.\u00a0 Let\u2019s go and get to grips with Training and Competence as they exist in ISO 13485<\/a>.<\/p>\n Just like the equipment, tools, hardware, software, utilities and facilities required by any organization and Quality Management System (QMS), People<\/strong> are also viewed as a resource to a QMS established and implemented to the requirements of ISO 13485 \u2013 It\u2019s in the name \u201cHuman Resources\u201d aka People as Resources.<\/p>\n But Resources and their requirements are not exclusive to Clause 6, of course not, that would make no sense.\u00a0 Because, you see, the processes of the standard are inter-related, and the use of the process flow diagram will show the relationships that exist between those processes of ISO 13485.<\/p>\n Moreover, someone must be ultimately responsible for those resources and have authority over decisions impacting those resources.\u00a0 Lest we forget, responsibilities and authorities are not the same thing \u2013 but that discussion is for another day, and possibly another blog.<\/p>\n But let me tell you something \u2013 the requirements around responsibilities and authorities as outlined at Clause 5.5.1 are an area that I see many non-conformances raised during auditing.\u00a0 But I divagated.<\/p>\n Who is responsible and has authority for all these resources and where can this be pinpointed in ISO 13485?<\/p>\n Well, let\u2019s take a wander to Clause 5.1e which makes it a mandatory requirement that Top Management ensure the availability of resources.\u00a0 This requirement is further cemented in importance at Clause 5.6.3d as part of the Management Review Output where output from the Management Review must include any decisions or actions related to resource needs.<\/p>\n So, you see, Resources are considered as integral a part of the QMS as any other part, if not one of the most important parts of the QMS.\u00a0 The absence of adequate resources will result in a failing QMS.\u00a0 But it doesn\u2019t end here.<\/p>\n Consider Clause 7.3.2f \u2013 Design and Development Planning which mandates that during D&D planning the organization must document \u201cthe resources needed including necessary competence of personnel\u201d <\/em>and let\u2019s jump to Clause 7.4.2c that\u2019s requires that when organizations are collating purchasing information, they are required to document the requirements for qualification of supplier personnel.<\/p>\n Given the extent of the role played by suppliers in the QMS, you can see where ensuring the competence of the suppliers into that very QMS cannot go undervalued.<\/p>\n For example, where organizations outsource Calibration processes, you want to make sure that the folks performing any calibration activity in the scope of your QMS are trained and competent to do so and have the evidence to support their claims of training and competence.<\/p>\n Another lens to frame the approach of supplier training and competence is where organizations outsource a process such as manufacturing or packaging and labelling.<\/p>\n Outsourcing does not remove the process from the scope of the organization\u2019s QMS, and in some cases, organizations may train outsourced suppliers to their own processes that align with the activities outsourced and maintain records of the training as a requirement of Clause 6.2e.<\/p>\n Which brings me nicely back to the origins of Training and Competence in ISO 13485.<\/p>\n But, what of Clause 6.2?<\/p>\n Well, let\u2019s recognize that in ISO 13485 Human Resources is a departure from what we would normally associate with the traditional function of \u201cHR\u201d in an organization.<\/p>\n Firstly, when we look at the Plan, Do, Check, Act cycle, we must recognize that the requirements of Clause 6 fall into the Planning Phase of the QMS, meaning that Clause 6.2 is related to the planning of resources.<\/p>\n Secondly, the planning phase includes how the organization will demonstrate, by documentation, the processes for establishing competence, how they intend to provide training needed by personnel and ensuring awareness of personnel.<\/p>\n Thirdly, when organizations have provided training, whether internally, or using an external training source, they must check the effectiveness of this training.\u00a0 Be it by a quiz, or shadow\/observation training, the organization must ensure that the training provided is effective and that the training will positively impact on the quality of the end product and ensure the continued integrity of the QMS.<\/p>\n Finally, risk plays a part in training and competence requirements as proclaimed by that all too familiar wording captured in the note at the very end of Clause 6.2.<\/p>\n The method used to check effectiveness of the training provided must be \u201cproportionate to the risk associated with the work for which the training or other action is being provided<\/em>\u201d.<\/p>\n The higher the risk to the end product or the QMS presented by the interaction of the person performing the activity associated with the manufacturing phase they are responsible for in the product realization or the part they play in the QMS, the more detailed the effectiveness check should be related to the training and competence provided by the organization.<\/p>\n A good example is auditor training.<\/p>\nWhat are considered Resources under ISO 13485?<\/strong><\/h2>\n
Responsibility and Authority of Resources<\/strong><\/h3>\n
ISO 13485 and Resources<\/strong><\/h3>\n
Clause 6.2 \u2013 Human Resources<\/strong><\/h3>\n