Informational Required Documents/Records in ISO 9001:2015

[qualprod]

okay thanks for the information
will you please guide me about the step by step procedure for the implementation of ISO:2015 as I am volunteer working in my organization

What is the time frame for the implementation?what it is usually done, to take some training and supported by consultants, in this way it can be implemented, depending of the size of the company, in 6 months.
If you choose to learn by gathering guides and info from the net, it can take more time, unless you have some experience. You can find here at lesnar, plenty of guide as well. Hope this helps

 

[Saman Fatima]

What is the time frame for the implementation?what it is usually done, to take some training and supported by consultants, in this way it can be implemented, depending of the size of the company, in 6 months.
If you choose to learn by gathering guides and info from the net, it can take more time, unless you have some experience. You can find here at lesnar, plenty of guide as well. Hope this helps

thank you for your reply

 

[Big Jim]

Obtain a copy of ISO 9002:2016. It's whole purpose is to guide someone in implementing ISO 9001:2015.

 

[Dazza]

Mandatory documents

Scope of the QMS (clause 4.3)
Quality policy (clause 5.2)
Quality objectives (clause 6.2)
Criteria for evaluation and selection of suppliers (clause 8.4.1)

Mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded)

Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
Records of training, skills, experience and qualifications (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Record about design and development outputs review* (clause 8.3.2)
Records about design and development inputs* (clause 8.3.3)
Records of design and development controls* (clause 8.3.4)
Records of design and development outputs *(clause 8.3.5)
Design and development changes records* (clause 8.3.6)
Characteristics of product to be produced and service to be provided (clause 8.5.1)
Records about customer property (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Record of conformity of product/service with acceptance criteria (clause 8.6)
Record of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Results of the management review (clause 9.3)
Results of corrective actions (clause 10.1)

Anything over and above the previously mentioned are what you as a company / organisation have deemed required

 

[Bob Jenkins]

Actually, the 7.1.5.1 note is in error here. The clause talks about "documented information as evidence of fitness for purpose" which would be reflected in the NDC result of MSA, but since MSA isn't a requirement of ISO 9001:2015, even that would be in question. No where in the standard does it say calibration records need to be documented, except in the case of traceability requirement (7.1.5.2).

 

[Antonio Vieira]

On 7.1.3 Infrastructure, is it fair to write a NC Audit because the organization doesn't have a safety procedure, even considering that this kind of document is a legal requirement?
Shouldn't this kind of be stated only as a OFI?

Thanks!!!

 

[Sidney Vianna]

We’ve had so many discussions over this. If we are talking about occupational health and safety, that is outside the scope of an ISO 9001 audit. And yes, any safety concern should not be reported as a NC. I have already hyperlinked the ISO APG paper on this a couple of times.

 

[Antonio Vieira]

Thanks Sidney!

Even instead of considering a NC, if we report an legal safety issue on a ISO 9001 audit as an "area of concern", as some Accredited Registrars nowadays state as an issue between a NC and an OFI , I still think is wrong.

 

[Big Jim]

It is wrong. Any certification body should immediately realize that they have a rouge auditor. Protest it immediately. The current version of ISO 9001 does not require any written procedures.

 

[Antonio Vieira]

On this ISO/IAF APG document, it´s not easy to understand this statement: "If environmental, health and safety, or other non-QMS related compliance obligations are found non-compliant, the QMS auditor may bring it to the attention of the audited organization, clarifying that it is not a
QMS finding."
When, on a QMS audit, finding an health and safety legal issue that the organization is not doing, should the auditor write an OFI in the report, or should him/her just say it to the auditee?