Clause 6 of ISO 9001 2015 standard is Planning.
This is an important clause of ISO 9001 2015 standard with respect to PDCA cycle. This is planning clause amongst PDCA – Plan Do Check & Act approach.
Planning has to be done against some expected / intended result. Intended result of Quality Management System is well defined in ISO 9001 2015 standard which is ;
- Compliance with client and statutory requirements.
- Enhancement of customer satisfaction
With respect to above intended result/ expected output of Quality management system, each process’s intended result / expected output shall be defined.
Clause 6.1 – Requires identification of Risk and opportunities and addressing actions ( preventive actions ) for same.
Definition of Risk is = Effect of uncertainty on expected output.
However practically Risk can be defined as a potential problem / potential non conformity.
Against every process which are determined during implementation of clause 4.4, organization is required to determine risks ( potential problems ) due to which the process will not achieve its intended result / expected output.
Once all possible risks ( potential problems ) are identified, against each problem organization shall implement solution ( preventive action ) so that such potential problem will not occur first time it self.
For example risk of procurement will be
- Delay in receipt of material from supplier
- Material received from supplier is not matching with specifications required.
- Cost of procurement is high
- Organization is dependent on few suppliers only for particular materials. etc.
So to prevent above potential problems, organization shall implement preventive action / preventive process proactively so that above problems will not occur first time. This is known as Risk management. In other words, purchase process is managed for problems stated above.
ISO 9001 2015 Quality management system standard also requires that all such preventive actions / preventive processes which are identified during risk management shall be evaluated for their effectiveness. This is required to ensure that process delivered expected output.
Whenever risks are identified, organization can deal with risks as one or more of following ways
- Eliminating source of risk
- Avoiding risk
- Changing likelihood or consequences of risk
- Transferring the risk
- accepting the risk
Best actions would be avoiding risk or eliminating source of risk .
Clause 6.2 – Requires defining Quality objectives & planning to achieve them.
Quality objectives are objectives which are consistent with quality policy. Quality policy describes intention and strategic direction of organization. Quality objectives are inline with same to measure if policy is effective or not. Quality objectives shall be prepared at relevant functions and levels of organization depending upon quality policy goals.
Quality objectives shall be measurable , shall have target, shall be monitored at defined frequency, shall be updated once monitored based on results of objectives.
ISO 9001 2015 quality management system standard requires to prepare an action plan for achievement of quality objectives. This action plan shall include actions to achieve objectives, target time frame for achieving objective and person responsible for same. Plan should also include resources required for achievement of objectives and how results of objectives would be evaluated.
Clause 6.3 – Requires adoption of change management process. .
To achieve objectives, after evaluation of objectives, based on identification of system non compliances, based on achievement of performance indicators, based on results of internal audit, based on customer complaints and customer feedback, based on results of analysis and evaluation….. organization may need to bring change in existing quality management system. This clause requires that such changes should not affect integrity of quality management system. in other words, intention of quality management system should not get affected with implementation of changes. Changes shall be analyzed for its consequences and approved prior to implementation.
We are leading ISO 9001 2015 certification consultants in ahmedabad gujarat india, leading ISO 9001 2015 certification consultancy in ahmedabad gujarat india, leading ISO 9001 2015 certification consultancy service provider agency located in ahmedabad in gujarat india. Organizations willing to obtain fresh ISO 9001 2015 quality management system certification or willing to upgrade their existing ISO 9001 2008 quality management system certification with newer version ISO 9001 2015 may contact us. We can help organization in upgrading their ISO 9001 quality management system as per 2015 version which includes training as per ISO 9001 2015 quality management system standard and implementation guideline.