Welcome to the first in another three part series of blogs related to Quality Management and supporting processes. My name is Stuart Hardie, a Quality Management Consultant with Lorit Consultancy, and this series of blogs will cover a few examples of “companion” documents that have been created to aid the users understanding, by providing guidance on how organisations can expect to meet the requirements of the standard.
Let’s be honest for a minute here, have you ever fully understood the meaning/intent of any ISO standard or other regulatory requirements document even after a few attempts at it? If your answer is no, please understand that you are not alone and that is part of the reason that these “companion” documents were created.
In today’s blog we are going to discuss ISO/TS 9002:2016 – Quality management systems – Guidelines for the application of ISO 9001:2015 which, as you may have guessed is the companion document for ISO 9001:2015 – Quality management system – Requirements.
In my last series of blogs we discussed the importance and benefits of implementing an ISO 9001:2015 based quality management system in your business however neither my blogs nor the standard itself provide the reader with any guidance on practical application and this is where ISO/TS 9002:2016 steps in to hopefully help fill some of those blank spaces in our understanding.
ISO/TS 9002:2016 is comprised of examples, descriptions and possible options that can aid organisations in addressing the requirements of the ISO 9001:2015 standard. The ISO/TS 9002:2016 is set of recommended guidelines only and does not include any additional requirements nor does its content supersede the requirements of ISO 9001:2015.
As an example, one area that causes some debate, during initial implementation of a quality management system, is in understanding and demonstrating the context of an organisation as well as understanding the internal and external factors that may impact on the quality management system. ISO/TS 9002:2016 removes some of the strain associated with this area of the standard by providing many potential issues that an organisation needs to consider as part of its context, such issue can include but are not limited to;
- External factors such as: Economic factors (exchange rates, inflation forecasts), social factors (unemployment rates and education levels)
- Internal factors such as: overall organisation performance, resource issues, product & service provision capabilities.
As well as outlining possible internal & external factors, ISO/TS 9002:2016 also then goes a step further by detailing possible sources of information that will aid in an organisations determination of context e.g.
- Internal documented information/meetings
- Conferences and industry specific events
- Meetings/feedback from customers and/or interested parties
ISO/TS 9002:2016 also provides guidance/examples for implementing some of the key updates made to ISO 9001:2015. As anyone who has read ISO 9001:2015 will be aware, the role of “Top Management” has been greatly emphasized and ISO/TS 9002:2016 includes detailed guidance on how organisations can demonstrate compliance to these enhanced requirements including increased accountability, leading an enhancing organisational engagement in the quality management systems.
What’s been detailed above is only a snapshot of the wealth if guidance that ISO/TS 9002:2016 provides its readers. The document delivers over 57 pages of guidance, walking its users through and provides a plethora of examples of what would be considered suitable objective evidence to demonstrate compliance with the requirements of ISO 9001:2015.
So if you or your organisation “cant see the wood for the trees” then I would highly recommend that you get your hands on a copy of ISO/TS 9002:2016 and the path forward should hopefully become much more obvious.
By Stuart Hardie, Quality Management Consultant