According to ISO 9001:2015 the organization needs to conduct reviews, verification and validation to ensure that the results of design and development meet the necessary requirements. If the approver performs one of these activities then you require this role. If your company already conduct these three processes you don´t need the approver to release the drawings and comply with the standard requirements.
A la hora de planificar tanto las etapas como los controles del diseño y desarrollo de sus productos y servicios la organización necesita tener en cuenta qué tipo de actividades van a ser necesarias así como la duración de las mismas y su grado de complejidad.
Con respecto a este punto 8.3.2 (planificación del diseño y desarrollo) debe de conservar los registros relativos para demostrar que se han cumplido con los requisitos de diseño y desarrollo. Es decir que la organización necesita proporcionar algún tipo de evidencia objetiva de qué es lo que incluyen las actividades de planificación. Esto se puede conseguir con el uso de cronogramas diagramas de Gantt o cualquier otro método de planificación como algún tipo de administrador de proyectos.
Implementing ISO 27001 information security risk management
Step 1: Identify the internal and external issues in our company
Step 2: Identify the risks and opportunities that would arise from each internal and external issue
Step 3: Bring the risk items identified during "step 2" to risk assessment
Step 4: Devise a separate plan to utilize the opportunities.
Step 5: Develop the risk treatment plan.
Answer:
To be compliant with ISO 27001 the risk management must follow these steps:
- Definition of a risk assessment and treatment methodology
- Performing of risk assessment (risk identification and risk analysis)
- Performing of risk treatment (risk evaluation and controls selection)
- Elaboration of a risk treatment report
- Elaboration of Statement of Applicability (SoA)
- Elaboration of Risk Treatment Plan and acceptance of residual risks
1. Shouldn't I review all the companies ISMS documents prior to creating the audit plan or is this not necessary for a Full System ISMS Internal Audit? The company advises me that there will be approximately 160 documents which they're expecting me to review during the scheduled audit where they've estimate d to take 5 days based on other audits they've had in the past. My understanding from the training is that I should review all their documents 1st, then develop the audit plan although it's not an ISMS mandatory document by the standard.
Answer: First it is important to note that ISO 27001 does not prescribe the steps for performing internal audit, only that it must be performed periodically, expected inputs and outputs. Considering that, the review of ISMS documents is not mandatory.
The review of ISMS documents prior to developing the internal audit plan is useful for you to identify situations specific to your organization that you should look for (e.g., the name of a record, the periodicity of a task, etc.), but not being able to review all documents should not be an impediment for you to plan your internal audit. In this case you should focus on documented information required by the main clauses from the standard (from sections 4 to 10), and on documents and methods of implementation defined for controls from Annex A stated as applicable in your Statement of Applicability (SoA), and make an observation that some specifics of your organization may not be properly audited, and that there is a risk that nonconformities related to them may be found during the certification audit (this is a risk that your management has to accept if you do not have time to review all documents).
Examples of minimal documents you must include in your review are the ISMS scope, ISMS policy, risk assessment and treatment report.
One additional thing we should mention is that 160 documents for an ISMS is a very uncommon quantity for a set of documents (for small and medium sized companies the set of documents would be no more than 40 to 50), then maybe you have space for an improvement related to decrease the quantity of documents.
SMART objectives are someone's responsibility
Answer
Both requirements can be matched without contradictions. For example, consider the following quality objective:
We want to reduce machine A defects rate by 10% in the next 45 days.
Who will be responsible for meeting this objective?
Supervisor A will be responsible for leading a team that will work to meet this objective
Answer:
You have asked about some very important elements in the OHSMS. Clause 4.2 (need & expectations of workers and interested parties) requires that you identify any parties (people, organizations, agencies) that have an interest in your OHSMS and determine what their expectations are. What do your workers need? What are the expectations of the OH&S laws you need to meet? Then you need to determine which of these expectations are legal or other requirements you need to comply with. This does not need to be written down, but it is definitely helpful to do so as it needs to be reviewed regularly.
Clause 4.3 (Scope of the organization) needs to define the boundaries and applicability of the OHSMS. In other words, exactly where do the rules, polices and processes of your OHSMS apply? This does need to be written down, and will be used by you r certification body to know where they must audit. You can learn more in this article: How to determine scope of the OH&SMS, https://advisera.com/45001academy/blog/2015/12/09/how-to-determine-scope-of-the-ohsms/
Finally, Clause 4.4 does not require any specific documentation, but instead refers to everything you put in place to meet ISO 45001 and your requirements. The clause states you need to establish, implement, maintain and continually improve your OHSMS. This means you need to define what the processes will include (establish), make sure everyone using the process understands the requirements (implement), keep this up by training new people who come on board and ensure changes are understood (maintain), and finally to make the processes better over time (continually improve).
To help make sure you have all the required documentation in your filing checklist, you can see the free whitepaper: Checklist of Mandatory Documentation Required by ISO 45001, https://info.advisera.com/45001academy/free-download/checklist-of-mandatory-documentation-required-by-iso-45001
Residual risk
Answer:
First it is important to note that ISO 27001 does not define what residual risk means, nor how it is determined.
However, consulting ISO 27000, which presents the vocabulary for information security management systems, and is referred on section 3 of the standard, residual risks are the risks remaining after risk treatment.
Considering that, the auditor statement is not correct, because at the point where residual risk acceptance is required (after approval of the risk treatment plan) some controls may not have been implemented yet, so calculation or residual risk is the only way for decision makers to have a estimative if selected controls are sufficient enough.
Maybe what the auditor has tried to say is that you cannot take as real a calculated residual risk until you measure the effects of implemented controls. You can consider it at most as an expected residual risk until the first measurement and evaluation of controls ef fectiveness, which will validate or not you calculation.
Implementing an environmental management system according to ISO 14001 is a voluntary decision and it’s a management decision. Your organization should evaluate the cost-benefit of that decision. To be certified, all ISO 14001 clauses should be considered.