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Auditing documentation requirements for ISO 9001 and ISO 13485
Answer:
If your Quality Management System is compliant with both ISO 9001 and ISO 13485, during the internal audit you need to check compliance with both standards. When it comes to common requirements or requirements related to the same elements of the system, you need to audit against requirements of both standards. Whichever standard has stricter requirements, those requirements should be applied and auditing should be done against those requirements.
Another option is to conduct separate audits for ISO 9001 and ISo 13485 but this would just mean that you will double the work.
For more information, see: How to create a checklist for an ISO 13485 internal audit fo r your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/ -
Risk calculation
Answer: For the purposes of a simple risk assessment, there is no difference if you add or multiply likelihood and consequence to calculate the risk. The difference would only make sense for statistical calculations, which are not required for simple risk assessment.
This article will provide you further explanation about likelihood and consequence assessment:
- How to assess consequences and likelihood in ISO 27001 risk analysis https://advisera.com/27001academy/iso-27001-risk-assessment-treatment-management/#assessment
These materials will also help you regarding likelihood and consequence assessment:
- Book ISO 27001 Risk Management in Plain English https://advisera.com/books/iso-27001-annex-controls-plain-english/ sh/
- The basics of risk assessment and treatment according to ISO 27001 [free webinar] https://advisera.com/27001academy/webinar/basics-risk-assessment-treatment-according-iso-27001-free-webinar-demand/ -
Confidentiality in IATF 16949
Answer:
The standard requires organization to ensure confidentiality of the customer-contracted products and projects under development, including related product information. The standard does not specify what kind of protection of the information should be applied and in most cases it is either defined by the customer or usual confidentiality rules of the company are applied.
As far as documenting the requirement in the manual goes, you should explain what rules for confidentiality your company applies and who is responsible to enforce those rules. -
Total Productive Maintenance in IATF 16949
Answer:
Total Productive Maintenance (TPM) has been introduced as a new requirement for the aIATF 16949 based on previous non-conformances noted in the areas of equipment management. Requirements for TPM are stated in clause 8.5.1.5 and it is required to document total productive maintenance system.
At a minimum, TPM procedure must include the following:
- identification of process equipment necessary to produce conforming product at the required volume;
- availability of replacement parts for the equipment identified in item a);
- provision of resource for machine, equipment, and facility maintenance;
- packaging and preservation of equipment, tooling, and gauging;
- applicable customer-specific requirements;
- documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance compliance metrics. Performance -
- to the maintenance objectives shall form an input into management review (see ISO 9001, Section 9.3);
- regular review of maintenance plan and objectives and a documented action plan to address corrective actions where objectives are not achieved;
- use of preventive maintenance methods;
- use of predictive maintenance methods, as applicable;
- periodic overhaul. -
Auditing clause 5.1.2
Answer:
Clause 5.1.2 refers to customer focus, and you can audit conformance to it by checking whether:
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently meet;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
Since this clause doesn't require documented information, you will need to check the interested parties and their needs and expectations, if they are determined and whether they include customers and regulatory bodies and to check what risks and opportunities are identified and what actions are taken to address them.
For more information, see: How the ISO 9001:2015 standard can help improve relationships with your customers https://advisera.com/9001academy/blog/2016/02/23/how-the-iso-90012015-standard-can-help-improve-relationships-with-your-customers/
These materials will also help you regarding customer focus:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Use of SWOT analysis
The following materials will provide you details with quality policy:
- Article - How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
- [free webinar] How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
- [free course] ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/ -
Change implementation challenges
Answer:
Here are few biggest challenges I see people are facing during the implementation:
- Resistance to the change in process
- Getting management buy-in
- Roles and responsibilities
- Implementation of the process
- Process (not) supported by tool
This article will help you address and overcome those challenges while implementing Change Management:
"How to overcome barriers while implementing the ITIL/ISO 20000 Change Management process" How to overcome barriers while implementing the ITIL/ISO 20000 Change Management process -
Quality policy and transition
When considering the task of formulating a quality policy I like that organizations focus on their customers and their requirements, because organizations exist with the purpose of serving customers. Considering that, look into the difference between clause 5.2 (ISO 9001:2008) and clause 5.1.2 (ISO 9001:2015). We went from “customer requirements” into “customer and applicable statutory and regulatory requirements”. So, when designing a quality policy the organization compromises should be not only about customer requirements but also about applicable statutory and regulatory requirements.
The following materials will provide you details with quality policy:
- Article - How to Write a Good Quality Po licy https://advisera.com/9001academy/blog/2014/03/25/write-good-quality-policy/
- White paper - Twelve-step transition process from ISO 9001:2008 to the 2015 revision - https://info.advisera.com/9001academy/free-download/twelve-step-transition-process-from-iso-90012008-to-the-2015-revision/
- Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/ -
External audit principles
Answer:
External audit principles are defined in ISO 19011 and they are the following:
- Have integrity and be professional
- Present fair and truthful results
- Exercise due professional care
- Care about confidentiality
- Be independent and impartial
- Use an evidence-based approach
For more information, see: Benefits and potential problems in becoming an ISO 9001 Lead Auditor https://advisera.com/9001academy/blog/2020/04/10/how-to-become-an-iso-9001-lead-auditor/
These materials will also help you regarding the audit:
- Book Discover ISO 9001:2015 Through Practical Examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ -
Responsibilities and process map
Answer:
Assigning responsibilities for processes should be easy. Once you identified the processes, you should put someone in charge of the process, usually it is a manager of the department to which the process belongs, for example, the owner of the production process will be production manager and for sales process the sales manager, and so on.
The key here again is to identify the processes first and then define the sequence and interaction between them. For example, information from sales process goes to design and development, then the design goes to production, then the product goes to storage, distribution and delivery to the customer. For more information, see: How to create an ISO 9001 process flowchart https://info.advisera.com/9001academy/free-download/how-to-create-an-iso-9001-process-flowchart