QSCONSULT - CONSULTANCY IN MANAGEMENT SYSTEMS
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
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:
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)
Corrective Actions and Preventive Actions and Control of Nonconforming Product
IMPLEMENTATION STANDARDS AND GUIDES
Standard:
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
