[fusion_builder_container background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”” padding_right=”” hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][fusion_text]Although ISO9001:2015 is quite specific on areas such as top management responsibilities it can be somewhat ambiguous on aspects such as operational requirements of your organisation.
For example in Section 8.5.2 Identification and traceability the standard states “the organisation shall control the unique identification if the outputs where traceability is a requirement”.
So what determines what is appropriate traceability? On some standards, such as the British Retail Consortium Global Standards for Consumer Products Traceability is a fundamental requirement and section 3.8 contains precise details of how this will be achieved.
However ISO9001:2015 only requires appropriate traceability be in place, but it doesn’t specify what this might actually be.
There may be a couple of ways to determine appropriate traceability. Firstly ask your customers what they require. Secondly consider whether any actions resulting from the mandatory process risk assessment would determine the level of traceability required.
If neither option clarifies what’s required then, once again, your organisation will still have to determine what appropriate traceability is needed based on experience.
Basically, from the organisational viewpoint, traceability is about risk. If your process creates an unacceptable number of rejections or the penalty for failure is high then you need to review the documentation your process produces to support any evidence based decision making corrective actions.
Finally, if your product includes externally provided processes, products or services then ensure your supplier provides appropriate traceability in the form of certificates of compliance/conformity or work under a suitable quality standard.
Peter Jones
April 2016[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]
