Clause 6.2 sets out specific requirements for the planning of quality objectives. This Clause requires you to document it. This Clause also requires you to monitor and measure and evaluate results to your planned objectives.
Adding risk-based thinking and management to planning. establishing quality objectives and how they will be achieved. Planning actions when changes to the QMS are made. Updating the QMS based on measuring ongoing effectiveness and any newly discovered risks or opportunities.
Clause 6 also stipulates that objectives must be thoroughly documented and that organizations must develop a written plan for achieving their documented objectives. The plan must include the identification of people responsible, a timeline for implementation, and key performance indicators for progress and success.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
The 2015 revision of the ISO 9001 standard only lists 4 mandatory documents as opposed to the six mandatory procedures required in the 2008 version.
Level 1 – Quality Manual
To begin, the first ISO 9001 document requirement is a quality manual containing details about the organisation's structure.
An ISO 9001 audit checklist helps the auditor to gather documentation and information about quality objectives, corrective action, internal issues, and customer satisfaction.
Although ISO 9001 no longer requires the quality manual as a mandatory document, it is perhaps still the most important part of any modern quality management system. Organizations often address the requirements of the standards by preparing a management system manual and by implementing procedures to control processes.
In ISO 9001, a Document is information that must be "maintained" and a Record is information that must be "retained". A Document will only have one valid version. It's describing the plan for how things should be done. Policies, procedures, manuals, specifications, SDS, are all examples of documents.
Six procedure are- Control of Documents, Control of Records, Internal Audit, Corrective Action, Preventive Action, Control of Non Conforming Products."
A Master Document List (MDL), aka Master Document Register is a complete list of documents including their metadata to be delivered as part of an engineering capital project.
Comprising 4 main tiers (quality manual, procedures, work instructions, and quality records) the QMS is a resource and documentation intensive effort.
ISO 9001 is the quality management standard established by the International Organisation for Standardization (ISO). ISO 9001 helps organisations implement clear, repeatable processes to maintain a quality service for their customers every time.
Clause 10 – improvement
This includes implementing any changes to meet customer requirements and improve customer satisfaction. This clause includes making relevant changes to improve products and services and taking corrective action to prevent and reduce undesired effects.
There are 10 sections (clauses) in ISO 9001, with additional subclauses related to the Plan-Do-Check-Act system.
The auditor looks at all aspects of a company's performance and processes. This procedure determines whether a company meets ISO 9001 requirements. The audit checklist looks at different categories of a company's compliance. These categories include its performance, leadership, operation, planning, and improvement.