Overview

Section 4
PROCESSES
4.1.A Determine the processes needed for the system ...
Soon enough to identify them, we must now determine the processes that are appropriate and necessary to meet the requirements.
  
Note 1 These include processes for management activities ... measurement, analysis and improvement.
Now management must arise as a process: input, review, issuance of directives and decisions.

OUTSOURCING

NOTE 2 An externally contracted process is a process that the organization needs for its system of quality management and the organization that decides who is played by an outside party.

Note 3 Ensuring control over outsourced processes does not absolve the organization of responsibilities to meet all customer requirements, legal and regulatory.

A company hired to conduct the service must also have a control to verify requirements are satisfied.

DOCUMENTS

4.2.1.D documents, including records (needed by the organization) that the organization determines are necessary to ensure the effective planning, operation and process control.
The existence of regulatory documents, records and documents deemed necessary, is set to avoid inefficiency, mistakes and failures. This is the criterion for establishing documents. The errors indicate that not comply with these documents (standards) or that the procedures are inefficient.

Note 1 A single document may include requirements for one or more procedures. A requirement for a documented procedure may be covered with more than one document. 
This flexibility allows the system pack documentary where appropriate.

4.2.3.C Ensure that identifies the changes and the status of the current version (revision) of the documents. 
Was recorded before each revision. Now it only asks that you register, when changing the version. If there are twenty revisions but only once changed the version, there will be a record.

4.2.3.F  Ensure that (identify) the documents of external origin, that the organization determines are necessary for the planning and operation of quality management are identified and controlled distribution and ...

The documents were an external referent, are now part of the system, making them requirements. Translation: must be met, such as Docs. Inmates.

Section 5
ADMINISTRATION

5.5.2 Representative of the Directorate  RD
Top management shall appoint a member of the organization's management who, regardless (regardless) of other responsibilities, must take the responsibility and authority ... 
The RD can not be something external, hired to be part of managers. 
The RD can not have another job, position, function. Must be dedicated to his job.  

Section 6

STAFF AND POWERS NECESSARY FOR THE PERFORMANCE 
6.2.1 Overview 

The personnel performing work affecting conformity to requirements (quality) of the product must be competent based on education, training, skills and experience.
 
The staff involved in meeting the requirements of the product / service, you will need education necessary for the job, training for the respective roles, skills and experience verified in similar position. 
  
Note: Compliance with the requirements of the product may be affected directly or indirectly by the staff performing any task within the system of quality management. 

The staff must be consistent for the functions and requirements.

Competence, training and awareness 
6.2.2.B Where applicable, provide training or take other actions (to meet those needs) to achieve the necessary competence. 
The organization responsible for training, if necessary.

INFRASTRUCTURE 
6.4 Work Environment 
Note The term "work environment" relates to those conditions under which the work is performed, including physical, environmental and other constraints, such as noise, temperature, humidity, lighting or weather conditions. 

Before people confuse the term and related AMBIENT ENVIRONMENT expression with implications for conservation, ecology, etc ... Now it is very clear that adequate infrastructure is asked to carry out the service / product.

Section 7

7.2.1 Determination of requirements related to product 
NOTE: The post-delivery activities include, for example, shares covered by the warranty obligations as maintenance services and supplementary services such as recycling or final disposal. 
This is a complete novelty. Now we must consider sales as a requirement of the rule, what was given as a grace of the organization, is now a requirement.

7.3.1 Planning and design development 
NOTE: The review, verification and validation of design and development have different purposes. Can be conducted and recorded separately or in any combination that is appropriate for the product and for the organization. 

The three stages: review what was done to test that meets the instruction. Verification, which verifies that the product or service has the features you expect and validation by the user or the personal quality control, is recorded separately or simultaneously.

7.3.3 Results of design and development 
NOTE: The information for production and service provision may include details for the preservation of the product. 

The tangible products must be careful of breakage or damage. Whether in transit, in storage or delivery of the product must be preserved. The way it should be registered in a document of the system.

7.5.3 Identification and traceability 
The organization must identify the product status with respect to measurement and monitoring requirements throughout the product realization. 

Traceability allows the state of the services / products during their production, in different moments of the construction or completion of the S/P, so that the S/P should be identifiable in the early stages of implementation/clothing, in the phase and half after having finished making. An example of what we have traced a car assembly line. At the beginning we have a chassis which is positioned a motor, then the body is assembled, then placed attachments control ... At one point the car should be tested at the plant and then stored. The construction process must be traceable, for it is recorded: stage, operations, and state of the phase-phase. When it happens (no one wants it) a failure, you can determine who was responsible for the phase that is leading to success or failure not to comply.

7.5.4 Customer Property 
NOTE: The property of the client may include intellectual property and personal data. 

Personal data has become a matter of capital or criminal transaction. Take care and keep in reserve the customer's data is a must.

7.6 Control of monitoring equipment and measuring 

a) Calibrated or verified, or both, at specified intervals or prior to use ... 
Be calibrated and verified. Gauge is to equate the measure of a measurement tool with an official standard. Check is to test (one or several times) that the measure obtained is reliable.

Section 8

8.2.1 Customer Satisfaction 
NOTE: The monitoring of customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on the quality of the product delivered, the user surveys, analysis of the loss of business, congratulations, warranties, and reports used by commercial operators. 

Now the rule formalizes the survey as a data source for measuring the perception of the client. Yet it is optional (may include). As appropriate, the organization will define the font that is the clear voice of the customer.

8.2.2 Internal audit 
The management responsible for the area being audited shall ensure that corrections are made and take necessary corrective action without undue delay to eliminate detected nonconformities and their causes. 

Both corrections and corrective actions must be done.

8.2.3 Monitoring and measurement of processes 
NOTE When determining suitable methods, you should consider the type and degree of monitoring and measurement for each of its processes in relation to their impact on compliance with the requirements of the product and the effectiveness of the management system of quality. 
Monitoring and measuring, two tasks for the quality. Continue to check in and see the current production of compliance with code. Measure is to determine the degree of effectiveness in functionality. 

8.5.2 Corrective Action 
f) reviewing the effectiveness of the corrective actions taken. 

8.5.3 Preventive action 
e) reviewing the effectiveness of preventive actions taken. 

Both the virtues of a caring model ISO 9001, promote effectiveness.