1. When was the new ISO9001:2015 standard released?

September 23, 2015.

2. Why should the ISO 9001 standard be revised?

All ISO standards are reviewed every five years to determine if they need to be revised to ensure that it is current and relevant to the market. The future ISO 9001:2015 will respond to the latest trends and be compatible with other management systems.

3. How long will the transition period be?

The transition period is three years until September 23, 2018.

4. How many revisions has the ISO9001 standard undergone?

Since the official birth of ISO 9000 in 1987, the standard has undergone four formal revisions. The years are 1994, 2000, 2008 and 2015.

5. The main changes of ISO 9001:2015 standard:

1) The standard has been rearranged in full 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) More demands are placed on top management. 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; advancing the application of process approaches and risk-based thinking; ensuring that the quality management system achieves its intended results; encouraging, guiding and supporting employees Contribute to the effectiveness of the quality management system; drive improvement; support other managers in demonstrating 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) The requirements for documents such as “documented procedures” are replaced by maintaining “documented information”, and “records” are replaced by evidence of retaining “documented information”.

6) New clauses "4.1 Understanding the organization and its environment" and "4.2 Understanding the needs and expectations of interested parties" are added; the organization is required to take the internal and external environment of the organization as the starting point for establishing, implementing and maintaining a quality management system; it emphasizes 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.

6. What are the seven management principles in the new version of the standard?

1) Customer orientation

2) Leadership

3) Employee awareness

4) Process method

5) Improvement

6) Evidence-based decision making

7) Relationship management

7. What is the roadmap for the new standard transition?

Internal auditor training, system revision, operation records, document review, on-site review.

8. When will ISO 9001:2008 expire?

The current ISO 9001:2008 standard will be valid until September 23, 2018. The ISO 9001:2008 and ISO 9001:2015 standards will co-exist during a 3-year transition period. By September 2018, all ISO9001:2008 certificates will be voided and expired. All certified organizations need to take steps to convert their current ISO 9001:2008 certificates to ISO 9001:2015 certificates during the 3-year transition period.

9. How can I obtain a revised ISO9001 standard?

Can be purchased from the National Standard Network

10. When will the new national standard be released?

The new version of GB/T 19001 corresponding to ISO9001:2015 has been submitted to the General Administration of Quality Supervision, Inspection and Quarantine and the National Standards Commission for approval, and is awaiting official release.

11. How are “risks and opportunities” reflected in the system documents?

For a quality system, "risk" can be understood as the possibility of non-conforming quality, and "opportunity" can be understood as an opportunity for improvement. "Design and Development of Products and Services", "Production and Provision of Services").

12. What is the core purpose of the new ISO9001 standard?

ISO 9001 focuses more on a core purpose, which is "the expected results of a quality management system (QMS)."

13. How to realize the knowledge part mentioned in the new edition?

This part is newly added, and it can be considered whether the organization's current knowledge is sufficient in terms of developing new customers and products, developing markets, and increasing customer purchase shares, and whether it needs to use external knowledge and conduct relevant cooperation with external parties.

14. Are the management manuals and management representative documents compulsory?

It is not necessary to cancel the previously established management representative method, provided that this method is applicable.

15. Who should understand the changing expectations in ISO 9001?

In your organization, many key stakeholders need to be aware of and understand the changes to ISO 9001:

With the removal of designated management representatives, senior management still needs to delegate relevant responsibilities to system managers.

Senior management needs to understand and align with the leadership elements of the new standard.

Process owners need to understand their obligations to manage the identified processes and associated metrics.

Internal governance teams (e.g. internal auditors and audit project managers) need to ensure that: they understand specific requirements related to the environment, leadership and performance.

16. Is an internal review of the new version required before the transfer?

Before applying for the renewal audit in accordance with the 2015 version, at least one complete internal audit and management review should be conducted in accordance with the revised documents according to the new version of the standard.

17. Will the quality manual be updated after the 15th edition?

The manual is a bridge linking the standard with the company's quality management. It is written in accordance with the terms of the standard. When the standard is updated, the manual must be updated.

18. What documents must be established for the new standard?

The 2015 edition does not mention which documents must be established (the 2008 edition requires the preparation of a manual and 6 necessary program documents), but for the convenience of the organization, the manual should be included, and the others are determined according to the needs of the organization.

19. What are the new requirements for the top leaders in the new version of the standard?

1) The implementation of the quality policy and the combination of the management system and the business are commitments to be fulfilled;

2) Raising awareness of process methods, enhancing full participation, enhancing continuous improvement and innovation is the embodiment of leadership;

3) It is really good when everyone is good. Leaders at all levels can prove that their leadership is also a part of leadership.

20. How to understand the cancellation of the management representative requirement?

The top management of the organization can personally participate in the planning, implementation and improvement of the system. It is not necessary to appoint a management representative. Of course, a management representative can also be appointed to implement it on their behalf.

21. Does the organization plan and implement the transformation work need attention?

1) Standard translation transformation and accreditation norm revision and adjustment

2) Specific policies and implementation requirements for conversion review

3) Preparation for conversion of accreditation bodies and certification bodies

4) Publicity and implementation training for certification bodies

5) Accreditation conversion implementation

22. Can it be upgraded in surveillance audit or certificate renewal audit?

Yes, if your system meets all ISO 9001:2015 requirements.

23. What are the two models updated by the new standard?

The new version of the standard has updated two models, namely the process model and the QMS structure model.

24. The three pillars of the new ISO9001 standard?

The new version of the standard has indeed created a good framework for us from the three aspects of MSS high-level structure, risk-based thinking, and leadership, and from different aspects of entity structure and thinking structure, which actually constitute the three pillars of ISO9001.

25. Customer groups for independent organizations adopting ISO 9001

Currently ISO 9001:2008 users, new users, and users based on ISO9001:2015 industry solutions.

26. Can enterprises still appoint management representatives?

  Can.

27. Does the ISO 9001 transition have an impact on the organization?

The potential impact of ISO 9001 on an organization depends on the organization and its quality management system. Relevant factors (such as the maturity and complexity of your existing quality management system, the existence of other management systems [such as ISO 14001 or OHSAS 18001], and your organization's current risk assessment and management) can significantly affect your The degree of change that the organization needs to undergo to meet future requirements in ISO 9001:2015.

28. The impact of the changes in the new version of 9001 on small organizations?

For small companies, all new changes also apply. The environmental nature of ISO 9001:2015 means that the methodology and level of formality should be compatible with the environment in which the organization operates. Simply put: the organization does not need to do more to meet customer and product/service regulatory requirements, however, the ISO 9001 management system approach should be used to achieve this goal. This management system approach can vary considerably in smaller companies. However, the expected output is the same, namely: meeting customer requirements and applicable regulatory requirements.

29. Internal stakeholders in the transition of large and medium-sized organizations?

The most important internal stakeholder will likely be the top management. ISO 9001:2015 requires: Greater understanding of the external environment, risk resolution, and greater responsibility for "quality leadership" from senior management (this goes hand-in-hand with the close link between management systems and product/service quality).

In the new standard, more emphasis is placed on the direct participation of internal stakeholders, or the oversight of the design, implementation, structure and performance of the organization's management system, thereby ensuring that the quality management system is an integral part of the organization's business processes part. If this is done well, the quality management system provides senior management with a valuable mechanism to better meet their internal governance and control responsibilities and to provide a good source of performance data in decision making .

30. Is it too late for ISO 9001 transfer training?

It's never too late to understand the topics that make your organization's management system more effective and bring greater benefits to your organization. The ISO 9001 transition will update the relevant requirements through good management practices. Since the last major revision of ISO9001, in the past 15 years, it can be said that earth-shaking changes have taken place.

31. Is the 2015 version mandatory to use FMEA?

  no.

32. What is risk-based thinking?

Risk-based thinking is something we all do automatically, often consciously doing things to get the best results.

The concept of risk has always been implicit in the ISO 9001 standard, and the new version makes it more explicit and extends it to the entire management system.

Risk-based thinking ensures that risks are considered from start to finish.

Risk-based thinking, making preventive actions an integral part of strategy and business planning

33. Which clauses of ISO 9001:2015 involve risk?

Introduction - Explains concepts based on risk thinking.

Chapter 4 -- Requires the organization to identify the QMS process and address risks and opportunities.

Chapter 5 -- Requires top management to:

-- Improve the meaning of risk-based thinking;

-- Identify and address risks and opportunities that affect product/service compliance

Chapter 6 - Requires the organization to identify risks and opportunities related to QMS performance and develop appropriate responses.

Chapter 7 -- Requires the organization to identify and provide the required resources.

Chapter 8 -- Requires the organization to manage its operational processes.

Chapter 9 -- Requires the organization to monitor, measure, analyze, and evaluate the effectiveness of actions to address risks and opportunities.

Chapter 10 - Requires the organization to correct, prevent or reduce unintended outcomes and improve the QMS, updating risks and opportunities.

Note: Risk is always present, and appropriate attention must be maintained at all times (Chapters 7 and 8).

34. Why use risk-based thinking?

Successful organizations consciously use risk-based thinking because of the benefits:

improve management

Establish a corporate culture of proactive improvement

harmonize

Ensure product and service quality consistency

Improve customer trust and satisfaction

35. How to do risk-based thinking?

Identify risks – this is based on context.

Use risk-based thinking to prioritize processes.

Manage processes in order of risk prioritization.

ISO 9001:2015 has no normative requirements for risk management.

ISO 31000 Risk management - Principles and guidance may be a useful reference document for organizations that want or need a more prescriptive approach to managing risk (but it is not mandatory to use it).

Balancing risks and opportunities

Analyze and prioritize risks

36. What are stakeholders?

Stakeholders are defined in Terms and Definitions in Chapter 3 of the 2015 Standard: that is, individuals or organizations that can influence or affect a decision or activity, e.g. customers, owners, people inside the organization, suppliers , bankers, associations, partners or social groups including competitors and opponents.

37. How to write the new version of the standard system documents?

For enterprises, without a unified format, it seems that there is more room to play, but in fact, the requirements are stricter. It is like a toddler who can walk steadily and quickly with the help of a walker or parents. , is something that takes practice.

38. What are the benefits of ISO 9001:2015?

The new standard requires the organization's quality management system (QMS) to be integrated and unified with the organization's business processes:

Give top management a more active role, and encourage senior management to lead and participate in the organization's quality management system to a greater extent.

Introduces the concept of "risk-based thinking," which guides organizations to focus resources on addressing key and major risks and areas that may present significant opportunities.

The element of "organizational environment" is added as the core and foundation of the entire quality management system. As an organization pursuing sustained success requires understanding and continuous monitoring of internal and external factors that have a significant impact on the organization, which may include macro and micro environments, changing customer needs and expectations, evolution of new technologies, and competitor dynamics Wait, know yourself and the other.

The unified standard structure is applicable to all management system standards, which is conducive to the integration and compatibility of different management systems.

39. What is the ISO 9001 certification conversion process?

There are two options for certification bodies and certified organizations.

Option 1: One-time audit

Manage the certification transition process with a one-time transition audit. This transition audit can be conducted concurrently with a surveillance audit, a recertification audit, or during a special audit process.

The above one-time audit only assesses compliance with the 2015 edition of ISO 9001. If an organization is determined to be non-compliant, certification will not be issued and the organization will not be able to obtain ISO 9001 certification.

Option 2: Staged review

Manage the certification transition process using a "phased" or "incremental" approach. The IAF has not yet made detailed provisions for the scheme, but the idea is to adopt the surveillance audits and re-certification audits originally used to maintain ISO9001:2008 certification, and conduct additional and follow-up assessments of the subcategories of the revised standard.

Once all requirements are met, the decision to grant certification can be made.

On the one hand, the "phased" conversion reduces the risk of the organization, but on the other hand, formulating such a conversion plan is more complicated, and requires careful discussions between the organization and the certification body to reach a good consensus.

40. It is recommended that ISO9001:2008 organizations take the following measures:

Carry out a difference analysis of the application of the new and old standards within the organization as soon as possible;

Establish a conversion implementation plan;

Train or inform all departments involved in the effectiveness of the management system of changes to their standards;

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;

When using the new standard, please contact the existing certification body providing services to make arrangements for the transition.

41. 2015 ISO9001 Accreditation Conversion Period

October 20, 2015 to September 15, 2018.

42. What is process audit?

Process method audit refers to the audit method that takes the actual operation process of the organization as the main line of audit, follows a systematic and interrelated audit mode, and makes a systematic evaluation of the organization's quality management system, process, performance and risk management.

43. What are the changes in the structure and terminology of the new version of the national standard?

In order to be better in line with other management system standards, compared with GB/T 19001-2008, the chapter structure (ie chapter order) of the new version of the standard has changed, which is consistent with ISO/IEC Guide Part 1/ISO Supplementary Provisions The high level structure given in Appendix SL remains the same. Some terms in the new version of the standard have changed, as shown in the following table:

44. What kind of documents are foreign documents?

Documents not required by the system, documents that need to be communicated and implemented within the organization, are all external documents.

45. The role and positioning of the new version of the conversion process?

The conversion process is determined by the participation of five institutions, and the order is as follows:

1) ISO (International Organization for Standardization)

Determine the four key nodes of each standard revision: promulgation of final international standards (FDIS), promulgation of formal international standards (IS), elimination of old standards, and invalidation of old standards.

2) IAF (International Accreditation Forum)

Jointly promulgated the transition period guidance document with ISO.

3) Accreditation body

The IAF guidelines will be refined to identify detailed requirements for accredited certification bodies.

4) Certification body

The ISO, IAF and accreditation body regulations and guidelines are then combined to determine the transition process and options available to certified organisations.

5) Accredited organization

Work with the certification body to develop a detailed optimal conversion strategy.

46. Difficulties in auditing the new version of ISO9001 (2015)

In the process of confirming the 2015 version of the standard, people have identified some difficulties that they think may be encountered in the audit, and these audit difficulties are all new requirements in the standard, which must be difficult for new auditors. of.

The audit difficulties identified in the DIS version ISO 9001:2015 validation process are: the environment in which the organization is located, stakeholders, measures to deal with risks and opportunities, organizational knowledge, and the type and extent of externally provided controls.

From an operational perspective, the new version of the standard further emphasizes the need to break away from "item-by-item review". Because in the audit process, it is mainly to review the process of the organization and track the trajectory of the process. When auditing the process of the organization, it is not only the process itself that is looked at. For example, when reviewing the organization's procurement, not only look at clause 7.4, but as a process, consider where the procurement needs come from, supplier evaluation, and incoming inspection. When auditing in accordance with the process approach, you will find that it is related to many other things, such as capabilities, non-conformities, etc. It may also be related to corrective actions or purchasing terms. As an auditor, ask yourself a question, whether the company has achieved the set process goals by doing so, and whether it can enable the organization to consistently achieve the set goals. If you feel that there is a problem, you need to further prosecute and verify that the organization's system does not meet the requirements of the ISO 9001 standard, and then conduct quantitative or qualitative analysis of the situation.

47. Should the recipient confirm that the controlled document is issued by mail?

Of course, if it can be achieved through the system (such as the file is clicked to open, the system will record it), if it cannot be achieved, you need to use other methods to confirm.

48. How to deal with enterprises whose original design has been controlled and deleted?

It can take production process transformation, process change, proofing, formulation of work instructions, planning of service items, etc. as the object of "design and development" management.

49. Does 9001 mandate process and product audits?

ISO 9001 does not explicitly require process and product audits.

50. How to promote a good quality system in the company?

Make good use of the basic principles of quality management, and implement the company's requirements, regulations, assessments and other content using the quality management system.