Seven Commonly Asked Questions About ISO 9001

audit iso 9001 Jul 29, 2021

The underlying principles of ISO 9001:2015 Quality Management Systems should help organizations to improve the way they do things. Take the wrong implementation approach to the requirements, and they can experience the negative effect.

ISO 9001:2015 is a standard that sets out the requirements for Quality Management Systems, it is the most common internationally recognized framework that helps organizations to become more effective and efficient, it also helps improve their interested parties' needs and expectations. There are over one million companies and organizations in over 170 countries that are ISO 9001 certified. However, there are many points to consider before implementing ISO 9001 requirements. This blog post aims to answer businesses’ most common questions when they have no prior experience or interaction with ISO 9001.

Here are the answers to the most commonly asked ISO 9001 myths.

1. Is it very complicated to implement and follow?

No, ISO 9001 may seem complicated at first, but the standard concepts are straightforward and simple to follow. Most businesses have to follow the ISO 9001 concept to be successful and lean.

2. Isn’t ISO 9001 meant to be applied only for large organizations with lots of resources?

No, the standard can be used by any organization regardless of their size or their complexity. ISO 9001 sets out a series of requirements and rules. Typically, the ISO 9001 requirements are followed by organizations if they are interested in becoming competitive in the market. ISO 9001 is a framework that indicates how businesses have to manage their records and data. Therefore, the organization size is not taken into account while developing the ISO 9001 standard.

3. Is it costly to learn about ISO 9001?

No, the ISO 9001 standard can be purchased from the ISO website or through the ISO store in your country. The cost to purchase the standard is typically between 100 to 300 USD. It is an easy read document and it is supported by many guidelines and examples.

4. Is this standard just for the manufacturer or applied to a special group?

No, the standard can be used by any organization. Either in the support industry, tourism, health, etc., the ISO 9001 is applicable and can be implemented. ISO 9001:2015 was specifically designed to be more accessible to organizations and businesses outside the manufacturing sector. The organization’s scope of activity is not taken into account while developing the ISO 9001 standard.

5. Will ISO 9001 help me increase my organization's profits?

Yes. ISO 9001 can help organizations to improve their financial benefits in many ways:
• Following ISO 9001 requirements can increase efficiency and productivity that help the organization to lower their costs
• Using ISO 9001 as a framework can lead to the improvement of customer experience resulting in repeat businesses and increased sales and revenue
• Complying with ISO 9001 will improve the business reputation within the market and can help attract more clients

6. Does it mean lots of extra paperwork?

Not necessarily. There are certain elements that you should document and keep records. The documentation level is left open for the organizations to develop the module that works best for them. There is a simple rule to follow, if you found a process difficult to follow, then do not blame the ISO standards. Rethink about your process and improve it in a way that suits your organization.

7. What are the mandatory documents required by ISO 9001:2015 Quality Management Systems?

There are twenty-four (24) pieces of evidence required by ISO 9001:2015. This includes policies, processes, and records.

1. Clause 4.3 scope of the organization
2. Clause 4.4.2 processes relate to the business operation
3. Clause 5.5.2 quality policy
4. Clause 6.2 quality objectives
5. Clause 7.1.5.1 monitoring and measuring resources
6. Clause 7.1.5.2 verifications or calibrations of measurement tools/software
7. Clause 7.2 evidence of competence
8. Clause 8.1 operation related records
9. Clause 8.2.3 review of products/services
10. Clause 8.3.2 design and development planning
11. Clause 8.3.3 design and development inputs
12. Clause 8.3.4 design and developments controls
13. Clause 8.3.5 design and development outputs
14. Clause 8.3.6 changes to design and development
15. Clause 8.4 external providers
16. Clause 8.5.1 control or outcomes
17. Clause 8.5.3 customer property
18. Clause 8.5.6 control of changes to outcomes
19. Clause 8.6 release of goods and services
20. Clause 8.7.2 nonconforming outputs
21. Clause 9.1 monitoring and measurement/ analysis and evaluation
22. Clause 9.2 internal audit
23. Clause 9.3.3 management review
24. Clause 10.2 nonconformity and corrective action

 

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