API TR 18TR1:2015 pdf free download.Guidance on Changes to API Q1, Ninth Edition
4.1.4 Planning
Intent of Section
The intent of this section is to establish requirements related to planning for the QMS.
Changes from Previous Edition
— Changed responsibility for QMS planning from top management to management.
4.1.5 Communication
4.1.5.1 Internal
Intent of Section
The intent of this section is to establish requirements related to internal communication for the QMS.
Changes from Previous Edition
— Changed the responsibility for internal communication from top management to management.
— Added requirement 4.1.5.1 b) results of analysis of data need to be communicated at relevant levels.
4.1.5.2 External
Intent of Section
The intent of this section is to establish requirements related to external communication for the QMS.
Changes from Previous Edition
— Added requirement 4.1.5.2 d) information required by product quality plans is to be provided when required by contract
4.2 Management Responsibility
Some of the responsibilities that were assigned to top management in Q1, 8th have been assigned to management in Q1, 9th.
4.2.1 General
Intent of Section
The intent of this section is to establish responsibilities for top management and management in an organization.
Changes from Previous Edition
— Added the use of KPIs for data analysis.
4.2.2 Responsibility and Authority
Intent of Section
The intent of this section is to establish the responsibility, authority, and accountability of personnel within the scope of the QMS.
Changes from Previous Edition
— Expanded the requirement for ensuring that responsibility and authority are defined and communicated to include accountability.
— The application of this requirement is now specified to be personnel within the QMS.
— Added the requirement for documentation.
4.2.3 Management Representative
Intent of Section
The intent of this section is to establish responsibilities and authorities for the management representative.
Changes from Previous Edition
— Added requirement 4.2.3 c) management representative is to ensure that actions are taken to reduce the likelihood of the occurrence of nonconformities.
— Added the requirement for top management to maintain a management representative.
4.3 Organization Capability
4.3.1 Provision of Resources
Intent of Section
The intent of this section is to establish responsibility for appropriate resource allocation to implement,maintain, and improve the effectiveness of the QMS.
Changes from Previous Edition
— Removed the word “continually” from the requirement to improve the effectiveness of the QMS [Q1, 8th,6.1 a)].
— Removed the requirement to provide the resources needed to enhance customer satisfaction by meeting customer requirements [Q1, 8th, 6.1 b)].
4.3.2 Human Resources
4.3.2.1 General
Intent of Section
The intent of this section is to establish the requirement for a procedure defining personnel competency and identifying training requirements and other actions necessary to achieve personnel competency.
Changes from Previous Edition
— Separated personnel competence from training and awareness.
— Added the requirement for a documented procedure defining personnel competence.
4.3.2.2 Personnel Competence
Intent of Section
The intent of this section is to establish the requirements for personnel competence and the associated records.
Changes from Previous Edition
— Added the requirement for personnel to be competent to meet customer requirements.
— Added the requirement to maintain records of the determination of personnel competence.
4.3.2.3 Training and Awareness
Intent of Section
The intent of this section is to establish requirements for QMS and job training.
Changes from Previous Edition
— Added requirement 4.3.2.3 b) customer-specified training and/or customer-provided training (when required).
— Added requirement 4.3.2.3 c) identification of training content to the requirement to identify training frequency.
4.3.3 Work Environment
Intent of Section
The intent of this section is to establish the requirements for an organization to identify and manage the conditions of the work environment needed to achieve conformity of product.
Changes from Previous Edition
— Merged the requirements for infrastructure and work environment into one section, “Work Environment.”
— Incorporated the note that was in Q1, 8th into this section to expand the work environment requirements to achieve conformity to the manufacture of the product.
— Expanded 4.3.3 b) to include maintenance of process equipment.
4.4 Documentation Requirements
4.4.1 General
Intent of Section
The intent of this section is to establish the minimum documentation requirements for an organization’s QMS.
Changes from Previous Edition
— Included the quality manual section under general instead of a separate section.
— Added requirement 4.4.1 b), Item 3) identification of processes that require validation.API TR 18TR1 pdf download.API TR 18TR1:2015 pdf free download
