In planning for changes, organization must consider among other thing, the availability of resources and purpose of changes

(a)  

Decision, where the needs to changes the QMS arises, must be recorded and documented,

(a)  

Where requirements of ISO 9001 cannot be applied to an organization or product they may be considered for a non-applicability.

(a)  

The reference for terms and definitions in ISO 9001, is “ISO 9000” highlighted under clause

(a)  

Communication with the customers shall include handling or controlling of customer property.

(a)  

Top management shall promote process approach and risk-based thinking within the organization

(a)  

Persons doing work under organization’s control must be made aware of the relevant quality objectives

(a)  

Documented information must be kept as being necessary to prove on the effectiveness of the Quality Management Systems (QMS).

(a)  

Where necessary, organization shall implement actions to prevent human error

(a)  

Documents required by the quality management system need to be reviewed and approved for suitability and adequacy.

(a)  

Records on management reviews needs to be maintain

(a)  

In ISO 9001:2015, infrastructure needs to be provided by the organization in-order to achieve conformity to product requirements

(a)  

Within Operation planning, it is a requirement for the organization to determine the criteria's for product acceptance

(a)  

It is made compulsory for records and results on product/ service review to be kept accordingly

(a)  

Organizations must implement inspections or other activities necessary to ensure outsourced product/services meets the specified requirements

(a)  

Audit shall be conducted with clear objectivity and with impartial audit process

(a)  

Nonconforming product is subject to re-verification when it is corrected.

(a)  

Corrective action controls need to be evaluated as to ensure that non-conformities do not recurs

(a)  

KPI and other objectives that need to be achieve that are relevant to the organization QMS operation need to documented

(a)  

When managing for change (MOC) key element involving, consequences, resources, allocation of responsibility and authority are some of the thing that the organization need to consider.

(a)  

The organization need to retain documented information that verify the fitness of purpose for all its monitoring and measuring devices

(a)  

The organization need to ensure all of its stakeholder that undertake works on behalf of the organization understands its quality policy, quality objectives, their contribution to the organization process and the impact of not complying with the quality requirements

(a)  

When changes was made to the design and process of the product, all changes need to be documented, reviewed, approved accordingly, and action must be to stem any catastrophic impact to the organization

(a)  

The organization need to establish evaluation criteria to its supplier for its to monitor its supplier performance in meeting the required specification set by the organization

(a)  

When dealing a product that are not conform to standard or criteria within the production line, this 4 options can be consider to mitigate the issues (i.e. either do correction on the product or segregation of the product or Inform the customer of the situation or obtained an authorization for acceptance under concession)

(a)  

Any nonconformities to product and service needs to explicitly describe and documented for its nonconformity, the action taken, any concession obtained, and the person who authorized it.

(a)  

The organization need to retain documented information that indicate the evaluation of performance and the effectiveness of its quality management system (QMS) by the management team that may decided on the needs to change the system, Opportunity for improvement and the resources needed for its quality management system (QMS)

(a)  

Any nonconformity raising from customer complaints need to be recorded and retained to describe on the nature of the conformity, the action taken, and the result from any corrective actions.

(a)