ISO 9001 Requirements
ISO 9001 Requirements Clause 8.1 Operational planning and control
Operations relate directly to QMS processes needed (see clause 4.3 – COP’s) to meet the requirements for the provision of product and service (PS) and include – sales and marketing; design and development; production and service provision; shipping; post delivery activities; control of externally provided processes, products and services; receiving; packaging; preservation; measurement and monitoring of product and processes, etc., whether performed onsite or off-site. This standard has replaced the word ‘realization’ (used in the 2008 version) with the word ‘provision’
The planning and control of these processes is essentially a repeat of clause 4.4, but with a narrower focus – on QMS processes needed to fulfill requirements for providing PS.
Processes that interact with and support operational processes include – control of documented information; human resources; provision and maintenance of infrastructure; IT; inventory management; laboratory services and control of MMR, QA; management; etc. Most of these support processes have been discussed in clauses 5-7.
All the general control requirements specified in 4.4 apply to QMS operational processes. In operational planning and control, we add specific requirements for each COP needed for provision of PS. The output of operational planning may take many forms each specific to the process being controlled and may be called by many names. Organizations have great flexibility in designing operational controls and what documented information it needs to use. The main objectives are to mitigate risks and to ensure consistency and conformity of products, services and processes to specified requirements defined in this section.
At this point you might find it useful to refresh yourself on the coverage of the general QMS process controls discussed under clause 4.4 as it provides all the details of process control elements
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article on this clause discusses in detail the specific controls to address each of the specific requirements of clause 8.1.