Discuss PECB ISO-9001-Lead-Auditor Exam Topic 3 Question 8

You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home security

services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business

operates from a single office and employs subcontract installers and service technicians across the country.

You have just completed the opening meeting. You are interviewing the Managing Director (MD).

You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction."

MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when

choosing home security services. We have not yet seen any business benefit from our quality management system."

You: "Tell me how you determine external and internal issues."

MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)."

You: "How have the outputs from your SWOT been used?"

Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this

have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.

AEstablish how many interested parties need to be consulted

BEstablish how the organisation reviews information about external and internal issues

CEstablish how the organisation shares information with external interested parties

DEstablish what actions were taken to improve the QMS

EEstablish whether the SWOT analysis has been reviewed by the procurement manager

FEstablish whether the SWOT analysis is focussed solely on the QMS

Suggested Answer: B, D

Question no: 22 Verified Answer: = B. Establish how the organisation reviews

According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 Reference:

1: ISO 9001:2015 - Quality management systems --- Requirements

2: Advisera, ''Context of the organization in ISO 9001:2015 explained'', https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

3: ISO Templates, ''ISO 9001 - Clause 4: Context of the organisation explained'', https://resources.iso-templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained

4: Advisera, ''How to implement continual improvement in ISO 9001'', https://advisera.com/9001academy/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

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23 comments · newest first

Marleen 10 months ago

Not sure if focusing solely on QMS is the right move.

Mireya 11 months ago

I think reviewing internal issues is key here.

Blondell 11 months ago

Surprised they haven't seen any business benefits yet!

Lawrence 11 months ago

I agree, not seeing benefits from ISO 9001 is concerning.

Alaine 11 months ago

Sounds like they need to leverage their SWOT better!

Ivan 12 months ago

I recall that we emphasized the need for the SWOT analysis to be actionable. I wonder if F could be a good option since it focuses on the QMS specifically.

Norah 12 months ago

I think we practiced a similar question where we had to identify how information is shared. Option C seems relevant, but I'm not entirely confident.

Lajuana 12 months ago

I'm a bit unsure about which audit trails to pick. I feel like understanding how they review internal and external issues is crucial, so maybe B?

Bernadine 1 year ago

I remember we discussed how important it is to link SWOT outputs to actual actions in the QMS. I think option D might be a good choice.

Arlette 1 year ago

This is a solid question. I think options B and D will be key to understanding how the organization is using the SWOT analysis to support their QMS and overall business strategy. I'll need to dig into the details there.

Huey 1 year ago

I'm a bit confused by the MD's comments about not seeing any business benefit from the QMS. I'll need to carefully review their SWOT analysis and how they're using it to drive improvements and achieve their intended results.

Vesta 1 year ago

Okay, this is a great opportunity to really understand how this organization is leveraging their QMS. I'll focus on exploring the SWOT analysis and how it's informing their strategic decisions and actions.

Lilli 1 year ago

Hmm, the MD's response about using SWOT analysis is a good starting point, but I'll need to explore further how they're actually applying those insights. Options B and D look like the best audit trails to follow.

Henriette 1 year ago

This seems like a tricky one. The MD's comments about not seeing any business benefit from the QMS are concerning. I'll need to dig deeper into how they're using the SWOT analysis outputs to drive improvement.

Graciela 1 year ago

I'm a bit confused on this one. I'm not entirely sure about the BRIM solution and the different objects that could be used. I'll have to review my notes and try to figure this out.

Filiberto 1 year ago

We definitely need to check both conditions in the if statements, so maybe 3 is a good guess?

Frankie 1 year ago

Whoa, this is a lot of information to process. I better take my time and not rush through this. Carefully considering each option is important to get the right answer.

Geraldine 2 years ago

Agreed. Outputs from SWOT should aim to enhance the QMS.

Laila 2 years ago

D sounds right. Improving the QMS is critical.

Annice 2 years ago

B makes sense. Internal and external issues are key for strategy.

Lili 2 years ago

I'm thinking B and D might be good options.

Geraldine 2 years ago

Yeah, especially about the SWOT analysis usage.

Annice 2 years ago

Wow, the question is pretty detailed. Seems challenging.

PECB ISO-9001-Lead-Auditor Exam - Topic 3 Question 8 Discussion