A second-party audit of a key supplier should focus on whether the supplier's QMS is suitable, effective, and capable of meeting requirements. ISO 19011 recommends considering context, changes, prior audit results, interested-party concerns, and effectiveness of key QMS processes.
B is relevant because outsourced processes affecting conformity may need to be audited or otherwise controlled. C and F are relevant because audit planning should consider changes since previous audits and previous audit results. D is relevant because ISO 9001 requires relevant interested parties and their requirements to be considered. I is relevant because the QMS must remain suitable and aligned with context and strategic direction. J is relevant because internal audit and management review are key mechanisms for evaluating QMS effectiveness.
A is mainly relevant to certification-body controls, not a supplier second-party audit. E is too prescriptive; ISO 9001 does not require annual audits of all external providers. G may be useful depending on scope, but the stronger required audit trails here are B, C, D, F, I, and J. H is outside ISO 9001 QMS audit scope unless directly relevant to contractual or QMS risks.

Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.
Reference:
ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence)

Explanation:

The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements
Records
Define product requirements
Product specification
Criteria for selection
List of requirements to be met by the external provider
Evaluation of potential external provider
External provider questionnaire
External provider selection
Approved external provider list
Communicate requirements
Purchase order
Monitoring of performance
External provider delivery times and quality issues
Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.
Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.
Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.
Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

ISO 9001:2015 Clause 7.5 - Documented Information establishes requirements for the creation, updating, and control of documented information within the Quality Management System (QMS).
Relevant ISO 9001 Requirements
Clause 7.5.2 - Creating and Updating
When creating and updating documented information, the organization shall ensure appropriate:
* Identification and description (e.g., title, date, author, reference number)
* Format and media
* Review and approval for suitability and adequacy
This supports the requirement that documented information be identifiable .
Clause 7.5.3 - Control of Documented Information
Documented information required by the QMS and by ISO 9001 shall be controlled to ensure:
* It is available and suitable for use where and when it is needed
* It is adequately protected
Control activities include:
* Distribution, access, retrieval and use
* Storage and preservation
* Control of changes (version control)
* Retention and disposition
These requirements support:
* Retrievable # Required by Clause 7.5.3
* Under change control # Required by Clause 7.5.3
* Identifiable # Required by Clause 7.5.2
Why " Translatable to Other Languages " is Incorrect
ISO 9001:2015 does not require documented information to be translated into other languages.
An organization may choose to translate documents where necessary for operational effectiveness, multinational operations, or legal requirements, but this is not a requirement of Clause 7.5 .
Therefore, being translatable to other languages is not a characteristic that documented information must demonstrate to conform to ISO 9001.
Evaluation of Each Option
Option
Required by ISO 9001 Clause 7.5?
Retrievable
Yes
Under change control
Yes
Translatable to other languages
No
Identifiable
Yes
ISO-Aligned Conclusion
Clause 7.5 requires documented information to be identifiable , retrievable , and controlled against unauthorized or uncontrolled changes . There is no ISO 9001 requirement that documented information be translatable into other languages .