ISO 9001 Checklist - Quality Web Based Training

1 iso 9001 :2015 Checklist with 9001:2008 Comparisons Ref. Questions from 9001:2015 (comments in italic are not in the standard) Yes/ no Observations/comments Copyright 2015 Russell CKLT9001-2015-JP12-newrequirements marked Page 1 of 41 Compliments of JP Russell - Not for resale or distribution beyond one organization/site/location Key: Yellow text indicates potential new requirements that may need to be included in the organization s Quality management system. The italic text is author comments. Abbreviations used in the Checklist : DI = documented information QMS = Quality management system.. 4 Context of the organization Understanding the organization and its context (1) Does the organization determine external and internal issues that are relevant to its purpose and its strategic direction?

2 NOTE 1: Issues can include positive and negative factors or conditions for consideration. NOTE 2: Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. NOTE 3: Understanding the internal context can be facilitated by considering issues related to values, culture and location. Comment: The business/operating environment has a context that is influenced by both internal and external issues. The auditor will need to know the purpose of the organization and its strategic direction.

3 The purpose may be something that describes the operation or perhaps be in a mission statement. The idea that an organization must have a strategic direction new. (2) Does the organization determine external and internal issues that are relevant to its ability to achieve the intended results of the QMS? Comment: Similar to the first question s requirement, but now an auditor will need to ask about the intended results of the QMS and follow up by asking about issues related to the organization s ability to achieve the intended results. (3) Does the organization monitor and review information about external and internal issues? iso 9001 :2015 Checklist with 9001:2008 Comparisons Ref.

4 Questions from 9001:2015 (comments in italic are not in the standard) Yes/ no Observations/comments Copyright 2015 Russell CKLT9001-2015-JP12-newrequirements marked Page 2 of 41 Compliments of JP Russell - Not for resale or distribution beyond one organization/site/location Understanding the needs and expectations of interested parties (1) In the context of the organization s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, does the organization determine: (1a) interested parties that are relevant to the QMS? (1b) requirements of these interested parties that are relevant to the QMS?

5 Comment: An interested party may be a stakeholder, person or organization ( ) that can affect, be affected by or perceive itself to be affected by a decision or activity. In today s global environment, there are times when it is important to share information for the well-being of society, such as safety or security. It may be appropriate to share information up and down the supply chain for Quality and/or availability concerns. (2) Does the organization monitor and review information about these interested parties and their relevant requirements? Determining the scope of the Quality management system (1) Has the organization established the scope of the QMS?

6 Does the scope address the boundaries and applicability of the QMS? Comment: Boundaries could be North American operations, Southeast terminals or job shops, and applicability could be all operating units except sales and finance. The requirements in this clause are similar to the 2008 version but more descriptive. (2) When determining this scope, does the organization consider: (2a) the external and internal issues referred to in (2b) the requirements of relevant interested parties referred to in (2c) the products and services of the organization? Comments: There is no requirement for a record or retained DI. As an auditor, you may seek documentation that a, b and c were considered or interview a person who is responsible for review and approval of the scope and then ask about a, b and c.

7 There is no, if appropriate, qualification for this requirement. Meaning an organization cannot select which are appropriate, they must consider each requirement when determining the scope. If it makes more sense to you, use the word factors, or external and internal factors. (3) Does the organization apply all the QMS standard requirements, if they are applicable, within the determined QMS scope? Comment: This is very general, but questions will help surface areas where the QMS requirements have not been applied. iso 9001 :2015 Checklist with 9001:2008 Comparisons Ref. Questions from 9001:2015 (comments in italic are not in the standard) Yes/ no Observations/comments Copyright 2015 Russell CKLT9001-2015-JP12-newrequirements marked Page 3 of 41 Compliments of JP Russell - Not for resale or distribution beyond one organization/site/location (4) Is the scope maintained as DI and available?

8 Comment: Maintained DI is the code for a document that must be under document control. Also, retained DI is the code for keeping a record. (5) Does the scope state the types of products and services covered, and provide justification for any requirement of this iso 9001 :2015 that the organization determines is not applicable? Comment: Almost no applicable clauses would be in clause 7 or 8. Some organizations do not design the product or service they provide; service organizations may not use equipment that needs calibration control; and so on. Conformity to iso 9001 :2015 may be claimed only if the requirements determined as not being applicable do not affect the organization s ability or responsibility to ensure the conformity of its products.

9 Comment: The above statement is not a "shall" requirement. iso 9001 :2015 Checklist with 9001:2008 Comparisons Ref. Questions from 9001:2015 (comments in italic are not in the standard) Yes/ no Observations/comments Copyright 2015 Russell CKLT9001-2015-JP12-newrequirements marked Page 4 of 41 Compliments of JP Russell - Not for resale or distribution beyond one organization/site/location Quality management system and its processes (1) Has the organization established, implemented, maintained and continually improved the QMS, including the processes needed and their interactions, in accordance with the requirements of this iso 9001 :2015?

10 Comment: There is a major emphasis on processes. Auditors need a good grasp of the dynamics and a fundamental understanding of what constitutes a process. (2) Has the organization determined the processes needed for the QMS and their application throughout the organization? Has the organization: (2a) determined the inputs required and the outputs expected from these processes? (2b) determined the sequence and interaction of these processes? (2c) determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes?