JUL
15th
Posted by: Tony Wilkinson
The final draft is out and the ISO committee are still planning for an issue in September 2015.
For companies new to ISO9001 the new standard will present a headache due the lack of specific documentation requirements, if only where do I start?
The format of the standard is intended to be addressed in the order of the clauses. Firstly review and analyze the context of the organisation looking at the 'big picture'
Then think about the processes required to address those needs, define a policy and objectives to measure success against the needs identified.
Then importantly carry out a Quality Risk assessment on the processes defined. Clause 7 then looks at the resources, infrastructure, equipment and knowledge needed to maintain and improve the management system and achieve objectives.
Clause 8 then covers the operational control aspects of the management system. Clause 9 looks at the evaluation of performance of the system (including audits & Management review) Finally clause 10 considers improvement in the effectiveness of the management system.
In a nutshell this appears to be how the standard is expected to work, only necessary documentation is required the main audit focus will be on top management leadership and outputs from the system such as risk assessments and data analysis. Some consultants may be tempted to go back to old style clause by clause based manuals that just re-write the standard.
This is not required and was not intended by the ISO Committee but may become a reality!
