Founded in 1987 by the International Organization for Standardization, ISO 9001 currently has more than 1.5 million users worldwide, with great recognition. ISO 9001 is the most demanded certification at international level. The last update of the ISO 9001 certificate was in 2015.
ISO 9001 certified companies guarantee their customers the quality of products and services offered; meeting and the requirements of the end customer. ISO 9001 certified company obtains benefits both satisfaction and customer loyalty, and economic performance, focusing on the following four principles:
- Systematisation . Promotes sales tracking, since sellers can better direct their attention to the customer and their needs, planning and organizing their work in a better way.
- Reducing errors. Using quality as a competitive element.
- Customer loyalty . The consumer will rely more on a product or service that certifies the quality that one can not guarantee the total quality in all processes.
- International approach . ISO 9001 is international and assures quality both nationally and abroad.
Advantages of ISO 9001 are evident both internally and externally:
The ISO 9001 certificate gives your organization an effective tool to analyze and determine the key points that should be improved, making review the proper implementation of its system of quality management complete and documented before an interlocutor recognized as it is SPG .
- Improvement of the key points of the organization.
- Strengthening the organization.
- Implementation of an effective quality management system, which allows reducing rejects and incidents, increased productivity and greater customer engagement.
Externally the ISO 9001 certificate puts your business in outstanding positions in their market and competitive advantages that allow it to offer products or services that meet the requirements of its customers and meet their needs.
- Market positioning.
- Competitive advantages over other companies in the sector.
- Maximum effectiveness of products or services offered by the company.
The GSP certification process consists of two stages:
First, from GSP we analyse documentation quality management system and conducted a site visit to the customer’s premises. This visit aims to review the status of the organisation and their understanding of the rules and determine the preparation thereof.
Then in a second step we make an audit visit to the facilities of the organisation based on a detailed embodiment for correct program. On this visit the degree of knowledge and implementation in different areas of the company involved in the activities of the scope and requirements of the management system is evaluated.
Learn the details about the certification process.
Learn the changes of the new version of ISO 9001:2015 standard
Although the update of the ISO 9001 has changed about 30% of the letter, this remains the same in spirit.
The first ISO 9001 standard was created in 1987 and has more than 1.5 million users. It has already even been accredited by third parties.
With ISO 9001 2015 no longer need a quality manual and responsible management is eliminated, a system more flexible and includes documentation applies principles of quality management.
Sections have also been modified, it has gone from 8 sections that had the previous standard ISO 9001 at 10 sections incorporating the ISO 9001 version 2015 .
The importance of integrating all aspects of risk strategy highlights quality management and organizations identify risks in advance in their systems and appropriate strategies to eliminate them . These can present several challenges, which can be considered as agents of internal changes, or as a tool for achieving the goals of the company.
the difficulties posed by small organizations are identified. For example, to have systematic prevention measures in an organized manner, even not having leadership problems have to learn how to manage risk or when they have failed to manage risk in a quality system.
Structure ISO 9001 2015
There are several sections that have been modified:
- 4th section change » management system quality » by » context of the organization «.
- 5th section changes » organizational responsibility » for » leadership «.
- 6th section changes » resource management » by » planning «.
- 7th section change » product realization » for » support «.
- 8th section change » measurement analysis and improvement » for » operation «.
A part of these sections has been added 9 Section » performance evaluation » and Section 10 » improvement «.
The 2008 version does not request recognition of the risks or mention the term or document. Demand the presence of a quality manual covers the development of information resource management in Section 6 and identifies Section 7 as product creation. Section 7.3 includes a list of requirements for the design and development process. Identifies the Section 8 as analysis and improvement and section 8.5 as an upgrade and subsection 3 requires the documentation of preventive actions.
ISO 9001 2015
The word risk appears 18 times in updating the quality standard . The level of detail increases information about the process and controls, expectation and identification of stakeholders and the risks they may face. It is essential to have a quality manual. However the documents needed for the QMS planning, operation and control of processes remain mandatory.
The Section 6 changes its title by planning incorporates goods to work with risks and opportunities. A structure of quality objectives and planning process. And planning for change.
The section 7 switches to support and includes 6.3 and 6.4 requirements of the 2008 version and less demanding version of section 7.6.
The Section 8 changes its name to operation and involves updated 2008 Section 7 paragraph 8.3 aspects and on the control of nonconforming product. The purchase process is called external control provision of goods and services. 8.3 becomes development of goods and services and no preventive action.
New sections in the ISO 9001 2015
Enter the Section 10 as «improvement» focused on issues of coexistence, adequacy and effectiveness of the QMS.
It is essential to specify in advance all risks and develop strategies to eliminate them. It aims to understand more about the organization, its context and the needs and expectations of the stakeholders to reduce or eliminate the risk. a structure of the simplified documentation is achieved and sustained by technological platforms. It points out how it will address both risks and opportunities as the planning process to meet quality objectives. The documentation shows why the instruments used are adequate and how they are controlled and helps point out about the skills of leaders.
This version of the standard has more flexibility to design a management system and the company as detailed as necessary whenever you consider the risks associated with the product or service. further explanation to understand aspects of the production process and operation is engaged. the whole rule is used as a tool for risk prevention.
Alembic management are pleasured to acknowledge some good thought from SPG certification and Bluefish pharmaceuticals team during audit period.
Continous Improvent for business excellence
It was amazing
I am very pleased with the audit. Raj knows a lot about English language academies. We also perform the audit in English.
CERTIFICATION ISO 9001:2015– ISO14001:2015– OHSAS 18001– 2015
We thank SPG for having helped us establish in our company the integral system in a practical way adapted to our business reality and with visible results in a short time, its didactic audits, its corrections and advice to focus on certain aspects have been fundamental, we hope to continue our relationship for a long time. Many thanks.