There are six (6) implementable clauses within ISO 9001:2015 Quality Management System Standard.
Within this series of posts over the next six weeks we will discuss the requirements to all six clauses and the correct interpretation thereof.
8.1 Operational Planning and Control
This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.1 – Product Realization Planning, but it has been extended to include implementation and control, as well planning. You should seek and record evidence that your organization has determined the design and its processes to meet the requirements of your customers and the requirements of your QMS. Evidence that the process, including all inputs, outputs, resources, controls, criteria, and process measurement and performance indicators being planned should be sought.
This is a new requirement. For those risks and opportunities that your organization has identified, you should seek evidence that these actions have been integrated into the management system; as such, these actions should be verifiable at process level – for example, evidence of controls, acceptance criteria and resources to address the risks and opportunities. Review the acceptability criteria; this may include targets, measures, values, KPIs, specifications and other criteria as relevant to the output.
You should ensure that the implemented processes are controlled as planned and that there is evidence that your organization has evaluated the effectiveness of actions taken when addressing risks and opportunities. Evaluate and record any evidence pertaining to planned and unintended changes.
Operational planning is about controlling the design and development process. The organization must ensure that all related activities take place under controlled conditions. The final product or service is the culmination of events that transfer customer requirements and expectations into a tangible product or effective service that conforms to specified requirements and expectations. Control product realization planning by:
Determining quality objectives for the product;
Determining requirements for the product;
Identifying processes required to achieve conformance;
Establishing processes required to achieve conformance;
Identifying documents to demonstrate conformance;
Identifying resources required to achieve conformance;
Maintaining and retaining documented information.
Your organization needs to plan in advance for how they will manufacture their product or deliver their service. The plans need to take into account the product requirements and any quality objectives that might be appropriate, resources and documents that may be necessary, what type of monitoring and/or inspection activities should be put in place to ensure the product or service will meet the requirements, and what types of records should be kept.
8.2 Requirements for Products and Services
8.2.1 Customer Communication
This requirement is directly comparable to the requirements of ISO 9001:2008 Clause 7.2.3 – Customer Communication. It has been expanded to include new requirements to obtain ‘customer views and perceptions’ instead of ‘customer feedback’. Some or all of the following specific customer communication should be observed and evidenced:
1. Marketing information;
2. Quotations and order forms;
3. Confirmation of authorized orders and amended orders;
4. Delivery notes and certificates of conformity;
5. Invoices and credit notes;
6. E-mail and general correspondence;
7. Site visit reports or notes to/from customer;
8. Customer feedback and complaints management process.
8.2.2 Determination of Requirements for Products & Services
This new requirement replaces ISO 9001:2008 Clause 7.2.1 – Determination of Requirements Related to Product Requirements. You should seek and record evidence that your organization has implemented a process to determine the requirements for the products and services that it intends to offer to customers.
This may also include the requirements from interested parties and also statutory and regulatory requirements relating to the product.
8.2.3 Review of the Requirements for Products & Services
This requirement is comparable to ISO 9001:2008 Clause 7.2.1 – Determination of Requirements Related to Product and Clause 7.2.2 – Review of Requirements Related to Product.
The requirement states that your organization should now include a review of the requirements arising from any relevant interested parties. You should seek and record evidence that these requirements are considered during product and service reviews.
8.2.4 Changes to Requirements for Products & Services
This is a new requirement. You should seek and record evidence that your organization has ensured that all relevant documented information; relating to changed product or service requirements, is amended and those relevant design personnel are made aware of the changed requirements.
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