Mandatory documentation for an audit of ISO 9001: 2015

It is the most hated day for all Quality Manager, but it is an inevitable date our Audit Management System will always come, like it or not. Therefore, the only measure we can take is to prepare in advance.

And if you want to shield your Quality System, do test the strictest Auditor, I recommend that you check if you already have covered these points:


1. Scope (4.3):

This document should be reviewed, updated and available to anyone who requires […] The scope of the quality management system of the organization must be available and maintained as documented information. […] A point at which the external auditors are very inquisitive is the date of the last update. (See How to define the scope of the Quality System)

Should take special care that our power to make clear what products and services covered by our company, with the justification explicit requirements of the Standard we consider not apply to our organization, as it says 4.3 are: “The scope should establish the types of product and services covered, and provide justification for any requirements of this International Standard that the organization determines that it is not applicable to the scope of its quality management system. ”

2. Operation Processes (4.4 and 8.1):

Although not explicitly, this section refers to have on hand, procedures updated process maps and records or other documentation to ensure that the processes are carried out as planned, including registration control external processes or outsourced .

“4.4.2 To the extent where necessary, the organization must:

a) Maintain documented information to support the operation of its processes;

b) Keep the information documented to have confidence that the processes are carried out as planned. ”

3. Quality Policy (5.2.):

We must have on hand the document which is embodied, updated and approved the Quality Policy of our system. It is certain that after the Auditor review our document, personally verify, among employees who know and have on hand. (See “Defining the Quality Policy”)

So it is recommended to make posters, print and paste the policy in each cubicle employees, and it is common to be audited completely forget what we explained previously. Even though we have an intranet where this policy is sure to be audited nervousness, forget up to its name.

That is why we must also support us with the record of the training we’ve done in the last year on politics, and also the standard requires communication and explanation:

“The quality policy must:

a) will be available as documented information;

b) be communicated within the organization;

c) be available to interested parties, as appropriate; Y

d) reviewed for continuing suitability. ”

Simply attendance list, signed by all employees, annual or biannual training that gave politics.

Remember that if an employee forgets policy to be audited, it is certain that the auditor will look for and ask for this record, if you have it, will raise a nonconformity to him, but if you do not check, it means that there is no evidence that you gave training, so the nonconformity be for you.

4. Quality Objectives (6.2)

It is a document in which are set quality objectives of the organization, aligned to the Quality Policy, updated once a year and approved by senior management, remember that as heads of Quality must verify that they are:

And we have evidence of monitoring or compliance with each target.

5. Resources Monitoring and Measurement (7.1.5)

Take an example, our company manufactures pipes for drinking water, then as Quality Managers, seek international or national standard governing this product.

In this case, the ASTM standard XX. This standard details the characteristics of the measuring equipment to be used to verify product quality, then, based on that detail, buy measuring equipment. Everything clear out here?

This section of the ASTM XX who served us for the purchase of equipment, will present evidence that the auditor entry. Then we proceed to create the measurement procedures of products. Adjustment, calibration and care of equipment, with their respective records, which will be the rest of presenting evidence of compliance with this point.

In case there is no rule detailing the equipment that we use, we proceed to ask the manufacturer, distributor or consultant. The document that this give us, detailing the necessary equipment for the measurement of our products, will be our evidence of compliance. (We should keep this document at hand, it is not necessary to update annually, but every time we change the product we make).

6. Skills (7.2):

This part is in custody of R.R.H.H. Generally the document containing this information, Manual profile posts, which should be detailed the following points:

“The organization must:

a) determine the necessary competence of persons performing under their control, a job that affects the performance and effectiveness of the quality management system;

b) ensure that these people are competent, based on education, training or experience appropriate;
c) where applicable, take action to acquire the necessary competence and evaluate the effectiveness of actions taken;
d) retain appropriate documented information as evidence of competition.
NOTE: The available actions may include, for example, training, mentoring or reassignment of those currently employed; or contracting or subcontracting of competent persons ”

7. Documented Information (7.5):

Remember that it is no longer mandatory to have a quality manual, neither the endless number of procedures, records processes and records generally drowned Management System bureaucratic, unproductive and useless processes, but that does not mean that disappeared procedures and records completely. Quite the opposite.

He simply must have on hand the procedures and records reviewed and updated in case of missing, compromise product quality or service we offer.

That is, if our company is a Call Center, a procedure for the “Missed Call Management” is vital, since phone calls are our business. BUT, if we are manufacturers of dentures, a procedure turns out to be not so useful; we would focus better on a procedure to ensure that the raw materials we use are non-toxic to humans.

Currently a procedure can be contained in a video, audio or the like that is more explanatory and dynamic product realization or service.

In short, we have procedures and records pertaining to our operations, including the list of external documentation that we use (Social Security Act, the Commercial Code, Laws concerning our operation)

8) outputs of design and development changes (8.3.5, 8.3.6)

If the company product design, the design team must have written the characteristics of the design and development of each of the products included in the scope, in addition to the changes to be made with due justification. The minimum requirements that this document should contain are:

“A) meet the requirements of the entries;

b) they are suitable for further processing for the provision of goods and services;

c) include or refer to monitoring and measurement requirements, where appropriate, and acceptance criteria;

d) specify the characteristics of the products and services that are essential for its intended purpose and its safe and proper provision.

The organization shall retain documented information on the outputs of design and development. ”

9) Control of processes, products and services externally supplied (4.1).:

Should the company have processes, products and services supplied externally (outsourced), should have documentation to support the periodic evaluations to support the verification of their ability to meet the requirements of the organization. It is recommended that at least an annual assessment by the Quality Manager, can be done through inspections of its facilities and processes, backed by questionnaires, checklists and photographs of the inspection.

“The organization shall determine and implement criteria for evaluation, selection, performance monitoring and reassessment of external suppliers, based on their ability to provide processes or products and services in accordance with the requirements. The organization shall retain documented information on these activities and any necessary actions arising from the evaluations. ”

10) Production and Service Provision (8.5, 8.2.3.)

The documentation must be on hand to this point are the procedures, forms, maps, information documents and records of the production process, storage, delivery and post-delivery (if applicable) of the products or services included in the reaching.

11) Traceability (8.5.2.):

If that traceability is a requirement of the product, we have records that allow traceability, ie, for example, if we produce medicines, foods or similar products, the law of almost everyone required to have traceability of such products, which is to know which batch belongs, the production line that was made, the date and time of production etc … the log where the production manager takes that information is our evidence. Of course, sometimes the Auditor, take a product from the cellar and demand to be proven traceability of the product, then we must be prepared, because the code or production information of the product, matches the binnacle Head of Production.

“The organization shall control the unique identification of the outputs when traceability is a requirement, and must retain documented information necessary to enable traceability.”


12) Change control (8.5.6):

This point refers to the record or log of changes made the product, production, service delivery, who or who authorized the changes, who or who make revisions to verify that the changes do not affect the quality of final product or service.

“The organization should review and monitor changes in production or service provision, to the extent necessary to ensure continuity in accordance with the requirements. The organization shall retain documented information describing the results of the review of changes, people change and authorize any necessary actions arising from the review. ”


13) Release of products and services, control of nonconforming outputs (8.6 and 8.7):

This is critical, but registration of the product is compliant and non-compliant, our management system has serious problems.

The first record, the Product As, is a set of forms where the approval is given out to the products or services that meet the requirements for sale or delivery.

Understood that should not be the head of production or the operator who took part in the production process, but an independent person of them, that is, one of your delegate.

“The organization shall retain documented information on the release of products and services. Documented information should include:

a) Evidence of conformity with the acceptance criteria;

b) traceability persons authorizing release. ”

The second record is the deal that is made with nonconforming product, and the measures taken to correct the problem.

8.7.2 The organization shall retain documented information that:

a) describe the nonconformity;

b) describe the actions taken;

c) describe all concessions obtained;

d) identify the authority that decides the action regarding non-compliance


14) monitoring, measurement, analysis and evaluation (9.1)

It refers to records supporting the monitoring, measurements and evaluations we do to ensure that our management system is working.

These records may be, the measures taken based on surveys of customer satisfaction, to improve the points indicated to us customers, internal audits, monitor corrective actions and other measures that we established to ensure the health of our Management system.

9.1.1. “The organization should evaluate the performance and effectiveness of the quality management system.

The organization must retain appropriate documented information as evidence of the results. ”

15) Internal Audit and non-conformities (9.2 and 10.2):

Have on hand the annual audit program and the audit program, with evidence tracking and non-conformities Corrective Actions.

“9.2.f) retain documented information as evidence of the implementation of the audit program and audit results.

10.2.2 The organization shall retain documented information as evidence:

a) the nature of nonconformities and any subsequent actions taken;

b) the results of any corrective action. ”

16) Management Review (9.3):

Evidence of Management Review, is perhaps where the emphasis will shift Auditor to evaluate our work, which is why we must have on hand the evidence of each of the inputs and outputs of this

Mandatory documentation for an audit of ISO 9001: 2015

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