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QUALITY - ISO9001

WHICH IS?

In short, ISO 9001 serves to improve the management of your company and increase the satisfaction of your customers. That is why the adoption of a management system is a strategic decision of the company.

The ISO 9001:2015 standard is a strategic component of an organization that defines requirements for the quality management system and the way in which a company should be managed based on risk management. It aims to  identify and satisfy customer needs. Applied in more than 170 countries around the world with more than 1 million companies already certified and many others in the implementation and certification phase, this standard is the basic management tool.

DOCUMENTATION EXAMPLES?


The new version of the standard does not require any type of specific documentation, however, compliance with the requirements must be demonstrated.

Here are some commonly used support documents:

RISK ASSESSMENT

The organization must manage its risks and opportunities

SEE FULL ARTICLE HERE

QUALITY POLICY

To be defined and communicated by top management (Must consider continuous improvement, compliance with regulatory and statutory requirements and continuous improvement of the system)

Examples:

Worten
 

QUALITY OBJECTIVES

Objectives with a view to continuous improvement are normally determined annually for each process:
 
Example for sales process:
Objective: 10% increase in billing over the previous year 
Indicator: Billing Volume
Follow-up frequency: Fortnightly 
Responsible: Mr. XPTO 

 

QUALITY MANUAL

Must Summarize how all requirements of the standard are met, reporting where possible to plans, Work Instructions, other manuals, etc. It is not even mentioned in the standard, nor is its existence mandatory.
 
examples: 
https://www.deltacafes.pt/assets/pdf/manual-de-gestao-integrado.pdf
http://www.inegi.up.pt/downloads/qualidade/MGQ_07.pdf
http://www.euroconsult.pt/Sites/ecsite/img/Manual_Qualidade_V13-cf.pdf


PROCEDURES

MANDATORY DOCUMENTED PROCEDURES  ISO 9001:2008 (ISO 9001:2015 DOES NOT REQUIRE

We emphasize that they are no longer mandatory but there is good practice in maintaining them. Nothing forces documents to be separated, so they can normally be integrated as follows:
 

Examples: ​

Document Control (Documents and Records)

Internal Audits

Corrective Actions and Preventive Actions  and Control of Nonconforming Product

IMPLEMENTATION STANDARDS AND GUIDES

 

Standard:

NP EN ISO ISO9001:2015

Support Guides:

User guide ISO 9001:2015 - APCER

ISO 9001:2015 Interpretive Guide - SGS

LEGISLATION AND INFORMATION SOURCES

INFORMATION SOURCES

STANDARD STRUCTURE

The ISO9001:2015 standard is organized according to Annex SL in order to integrate with all ISO standards.

national preamble
Preamble
Endorsement note
Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach 
0.4 Relationship with other management systems standards
1 Purpose and field of application
2 Normative references
3 Terms and definitions 
4 Organization context 
4.1 Understanding the organization and its context
4.2 Understanding stakeholder needs and expectations 
4.3 Determining the scope of the quality management system 
4.4 Quality management system and respective processes 
5 Leadership
5.1 Leadership and commitment 
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Change planning
7 Support
7.1 Resources
7.2 Competencies
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operationalization
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of processes, products and services from external suppliers
8.5 Production and provision of the service
8.6 Release of products and services
8.7 Control of non-conforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal Audit
9.3 Management review
10 Improvement
10.1 General
10.2 Non-compliance and corrective action
10.3 Continuous improvement
Annex A (informative) Clarification of the new structure, terminology and concepts
A.1 Structure and terminology
A.2 Products and Services
A.3 Understanding stakeholder needs and expectations 
A.4 Risk-based thinking 
A.5 Applicability 
A.6 Documented information 
A.7 Organizational knowledge 
A.8 Control of processes, products and services from external suppliers 
Annex B (informative) Other Standards relating to quality management and quality management systems
quality developed by ISO/TC 176
Bibliography 

ISO9001 AUDIT CHEK-LIST

Download here:

Lista
Avaliação Risco (1).webp
Avaliação Risco (3).webp

VIDEOS AND WEBINARS

NIGEL CROFT - WHAT MATTERS IS THE RESULT

ISO 9001:2015 What matters is the result - Lecture by Nigel Croft (Chairman of the ISO9001 World Committee) and Dr. Luiz Carlos (President of the Brazilian ISO9001 Committee). A well-explained demystification of the standard and without non-conformities in requirements that do not exist in the standard. Excelente initiative by Templum Consultoria .

SGS

ISO 9001:2015 – What you need to knowr

 09/14-/2017

NEW STANDARD ISO9001:2015

02/10/2018

INTRODUCTION TO ISO9001

ISO 9001:2015 

ISO 22301 - APCER WEBINAR

Business continuity standard 

Risk Management in Practice

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