ISO9001 has ushered in the new version of ISO9001:2015, so how do enterprises respond to the new version of ISO 9001 standard? Let's learn more about

1. Important changes in standards

The ISO9001:2015 "Quality Management System Requirements" standard was released on October 23, 2015. The new standard has significant changes relative to the 2008 version. The International Organization for Standardization (ISO) and the International Accreditation Forum (IAF) have jointly issued the "ISO 9001: 2015 Edition Conversion Implementation Guide". The standard conversion period is 3 years, and the certified organizations need to implement conversion certification based on the new standard within 3 years. .

Compared with the 2008 version, ISO 9001:2015 has the following major changes:

1. The standard has been rearranged completely in accordance with the format of "Annex SL" in "ISO/IEC Guidelines 2013".

2. Replace "products" in the 2008 edition with "products and services"; strengthen the distinction between "products" and "services"; enhance the applicability of the standard to service organizations.

3. Put forward more requirements for top management; increase "take responsibility for the effectiveness of the quality management system; ensure that the requirements of the quality management system are incorporated into the business operations of the organization; promote the application of process methods and risk-based thinking; ensure quality The management system achieves its intended results; encourages, guides and supports employees to contribute to the effectiveness of the quality management system; drives improvement; supports other managers in demonstrating their leadership within their areas of responsibility".

4. Replace "procurement" with "externally provided processes, products and services"; requires ensuring that externally provided processes, products and services do not adversely affect the organization's ability to continue to provide products and services to customers.

5. Replacing the requirements for documents such as "documented procedures" by maintaining "documented information", and replacing "records" with evidence of retaining "documented information".

6. Newly add "4.1 Understand the organization and its environment" and "4.2 Understand the needs and expectations of related parties"; require the organization to take the internal and external environment of the organization as the starting point for establishing, implementing and maintaining a quality management system; Emphasize quality management The suitability of the internal and external environment of the system and organization.

7. Emphasize the core concept of "risk-based thinking"; the whole process of the standard from "planning-implementing-checking-improvement" (Chapters 4 to 10) runs through the concept of risk control.

8. Manage "organizational knowledge" as a resource.

9. The specific requirements of "Precautionary Measures", "Quality Manual" and "Management Representative" have been deleted.

10. Revised quality management principles; embodies three core concepts - process, risk-based thinking and PDCA cycle; most requirements are about output, focus on achieving expected results, focus on performance.

2. In response to changes in standards, how should enterprises meet the requirements of the new standards from concepts and actual operations

There are many changes in the standard, and the organization should comprehensively plan, update and improve its quality management system on the premise of evaluating the gap between the original quality management system and the new version of the standard. In order to meet the requirements of the 2015 version of the new standard, it is suggested that the organization should focus on the following work to adapt to the new requirements of the new standard on the basis of an accurate understanding of the changes and connotations of the standard:

1. Identify, analyze and determine the current internal and external environment related to the organization's goals and strategic direction and affect its realization of the expected results of the quality management system, as one of the foundations for establishing and changing the quality management system.

ISO9001:2015 Standard 4.1 requires the organization to determine the internal and external factors related to the organization's goals and strategies that affect the organization's achievement of the expected results of the quality management system, and to monitor and review relevant information. This is the basis and starting point for an organization to establish and maintain a quality management system. Because the environment faced by the organization is comprehensive, uncertain and complex, it has an important impact on the quality management system of the organization. Therefore, in order to meet this requirement, the top management of the organization and the operation planning department should use methods such as SWOT analysis method and PEST method. , value chain analysis, industry environment analysis, competitive situation analysis and other environmental analysis methods, comprehensively, systematically, scientifically, and timely analyze the ecosystem in which the organization is located, and analyze the external business in which the organization is located from the aspects of politics, economy, technology, and nature. Environment (objective factors); analyze the organization's internal conditions (subjective factors) from the perspectives of resources (including knowledge), culture, values, performance, etc., accurately and clearly give yourself a position, and determine the organization's own advantages (strengths), disadvantages ( Weaknesses), opportunities (challenges), risks (threats), and dynamic monitoring and review; starting from enhancing the suitability of the quality management system to the internal and external environments, planning, establishing, operating, changing, and improving the organization's quality management system, so that quality The management system is completely integrated into the organization's business activities and the internal and external environment, and solves the two layers of the quality management system and the daily management of the organization from the source; it completely changes the past for some organizations to copy the standards, and the quality management system documents are monotonous, out of reality, and poor operability. System and system, quality for quality's sake, can not guarantee the consistency of product and service quality from the essence, nor can it promote the organization to maintain continuous success in the face of changing environment. For example, when an organization determines quality goals, decides to develop new products, allocate resources, and determine the control method of external suppliers, it should consider what the government encourages, allows, and prohibits, the country's current industrial policies, investment and financing environment, technology level, local The external environment such as the status of natural resources, and the internal conditions such as organizational governance methods and capabilities, personnel technical capabilities within the organization, organizational knowledge, and the organization's ability to control outsourcers should also be considered.

2. Identify, analyze and determine the relevant parties and their requirements that have an impact or potential impact on the organization's ability to continuously provide products and services that meet customer requirements and applicable legal and regulatory requirements, and also serve as one of the foundations for establishing and changing the quality management system.

Organizations have many stakeholders, including customers, shareholders, external suppliers, employees, government regulators, social groups, banks, etc. These related parties have an impact or may have an impact on the organization's ability to continuously provide products and services that meet customer requirements and applicable laws and regulations, and the normal survival and development of the organization is inseparable from related parties. Due to the different needs and expectations of different parties, the impact on the quality management system is different, and sometimes the needs and expectations of the parties are even conflicting. In order to eliminate and reduce this impact, the organization, especially its top management, may comprehensively identify and accurately determine the relevant parties and their requirements related to the organization's quality management system through appropriate means such as surveys, discussions, and interviews, and dynamically monitor and reviewing information about these interested parties and their requirements, responding to the concerns of interested parties, acknowledging their legitimate interests and rights, assessing the ability of interested parties to influence the organization, respecting the beneficial opinions of interested parties, and properly handling conflicts between interested parties and the organization The benefits of this information are comprehensively summarized and used as the basis for the organization to plan, establish, operate, maintain, change and improve the quality management system. The needs and expectations of its stakeholders should be considered in determining the inputs, outputs, risks, opportunities, activities and requirements of each process. For example, when planning the design and development process, it is necessary to consider the needs of customers and users to participate in the design and development, as well as the control level of the design and development process expected by customers and other relevant parties.

3. Review the applicability of the standard requirements and the organization, and accurately and reasonably determine the scope of the quality management system.

In the past, some organizations, because they did not correctly understand the meaning of "deletion" in the original standard, mistakenly deleted the design and development that the organization was responsible for and could demonstrate the organization's capabilities. The new version of the standard requires that all requirements in this standard that apply to the scope of the quality management system defined by the organization be implemented. Only those clauses that, after review by the organization, do not affect the organization's ability and responsibility to ensure conformity of products and services and to enhance customer satisfaction can be determined not to be applicable, and the reasons for that should be given. The organization may attempt to determine whether a requirement is not applicable by answering the following questions: (1) What are the consequences if this requirement is not met? (2) Would customer satisfaction be enhanced if retained and met? (3) The organization is not responsible for Who is responsible? (4) If it is an outsourced process, what is the responsibility of the organization? (5) If a requirement is claimed to be inapplicable, will it affect the organization's ability to continuously meet customer requirements and legal and regulatory requirements? Otherwise, no reason shall be given Clarifies that some requirements of the standard do not apply to the organization's quality management system. To apply the new standard, the organization should clarify the boundaries and applicability of the organization's quality management system after fully considering the internal and external environment it faces, the requirements of the identified interested parties, and the products and services provided by the organization, and redefine the quality management system. the scope of the system.

4. Further determine the responsibilities of the top management and each manager in the quality management system, and fully reflect the leadership role.

The standard specifies 10 responsibilities of top management in "5.1 Leadership and Commitment"; 6 of them are newly added: taking responsibility for the effectiveness of the quality management system, ensuring that the requirements of the quality management system are incorporated into the organization's business operations, To promote the application of process methods and risk-based thinking, to ensure that the quality management system achieves its intended results, to encourage, mentor and support employees to contribute to the effectiveness of the quality management system, and to support other managers in demonstrating their leadership within their areas of responsibility. The organization should further define the responsibilities of top management in the quality management system on the basis of a clear understanding of standard changes. The top management of the organization should clarify the division of responsibilities in the quality management system and the quality responsibility assumption mechanism; clearly define the positions and responsibilities of managers at all levels in the quality management system; according to the strategic direction of the organization in a specific period, take the lead in risk-based management. Thinking, using the process method, accurately analyze the internal and external environment of the organization, and evaluate its impact on the strategic direction of the organization, identify the existing risks and opportunities, and use this as the basis for the planning and implementation of the organization's management system. The top management should direct and control the design of the organization's management system to ensure that the quality management system is driven by business needs, oriented to achieve desired business results, and reflects the characteristics and nature of the organization's business life cycle. Top managers should also take appropriate measures to guide and help employees learn, master and apply process methods, strengthen risk awareness education, and make risk-based thinking a common habit for employees; positions should be reasonably determined according to the nature and characteristics of the quality management system and responsibilities, and by establishing a reasonable mechanism to ensure that other managers play an effective role in the quality management system; top management should identify improvement opportunities, determine improvement priorities, set improvement goals, select improvement measures, and evaluate improvement. The effect is to promote the continuous improvement of the organization's quality management system. Ensure that the organization's quality policy is consistent with the organization's environment and strategy, and ensure that quality objectives are established at relevant levels, functions and processes.

5. Identify and determine the risks and opportunities faced by the organization and its processes, and plan risk control measures.

Standard 6.1 requires the organization to identify risks and opportunities that need to be addressed and to plan actions to address them. Organizations should establish appropriate risk identification, analysis, evaluation, and processing processes as needed, fully and fully identify organizational risks, strategic risks, compliance risks, and operational risks, and formulate corresponding control measures based on the relevant risks and opportunities identified in each process. Ensure risks are manageable and opportunities are available. Enhance beneficial effects and avoid and reduce adverse effects.

6. Comprehensively plan and manage "changes".

The new standard puts forward requirements for quality management system change planning in 6.3 "Planning of Changes". Changes are required to be planned and implemented systematically, taking into account the purpose of the change and its potential consequences, the integrity of the quality management system, the availability of resources, and the assignment and reallocation of responsibilities and authorities. 7.5.3e) "Change control" on documented information requires version control of document modifications; 8.1 "Operational planning and control" "The organization shall control planned changes and review the results of unintended changes, taking action as necessary. Mitigate any negative effects", requires changes to operational control planning; 8.2.4 requires changes to product and service requirements; 8.3.6 requires changes to "design and development" controls; 8.5.6 requires changes to production and service delivery changes require review and control to ensure consistent compliance with the requirements. The organization should plan and control the changes of the system and each process as a whole, pay attention to external dynamic changes, plan the timing of changes, grasp any potential consequences of changes, identify risks and opportunities before making changes, and formulate countermeasures , in a timely and comprehensive review of the effectiveness of changes.

7. Identify, acquire, share, innovate, and apply knowledge related to organizational processes.

The new standard in 7.1.6 puts forward requirements for the organization's knowledge management, requiring the organization to determine the knowledge necessary to operate the process and achieve product and service conformity. Knowledge should be maintained and accessible to the extent necessary. When responding to changing needs and trends, the existing knowledge base should be considered and other required knowledge should be determined and updated. In order to meet this requirement, the organization should establish a knowledge management process, clarify the responsibilities, methods and requirements of knowledge acquisition, sharing, innovation, and application, put knowledge management at a strategic height, allocate necessary personnel and conditions for knowledge management, and continuously improve knowledge management. , to ensure the quality management system and the knowledge resources required for the daily operation and management of the organization.

8. Targeted control of all externally provided processes, products and services.

The new standard 8.4 has major changes from the original standard 7.4. The organization should, on the premise of fully identifying the changes, improve the original procurement process management in accordance with the requirements of the standard, and stabilize the organization according to the products, processes and services provided by external suppliers. The degree of impact on the ability to accurately provide the ability to meet customer requirements and applicable legal and regulatory requirements determines the effective control of different suppliers and the processes, products and services they provide.

3. Suggestions for Enterprise Conversion Certification

In order to do a good job of standard conversion certification, it is recommended that organizations take the following steps:

1. Organize new standard training. Targeted training of new standards for new employees, internal auditors, and managers above the middle level.

2. Compare standards, identify changes and differences, and analyze the differences between the application of new and old standards within the organization as soon as possible, and determine the differences between the organization's quality management system and the requirements of the new standards.

On the basis of learning and understanding, compare the changes of the old and new standards, as well as the differences between the requirements of the new standards and the company's current management system, and determine the management system information that needs to be revised and improved.

3. Develop a work plan and establish a conversion implementation plan. According to the actual situation of the organization, combined with the certification requirements, plan the conversion work plan. Clear work content, responsible departments, measures, output results, and completion time.

4. Update the existing management system in accordance with the new version of the standard to ensure that the system continues to meet the requirements of the new standard and maintain its effectiveness. Update system related documents, operation, carry out internal audit and management review.

5. When using the new standard, please contact the existing certification body providing services to make relevant arrangements for the conversion. According to the organization's certification rhythm, communicate with the certification body, and carry out conversion certification in conjunction with surveillance audit or re-certification.