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ISO 9001:2015

Company: Client-no.: Order-no.:

Requirements The org. shall establish Q-objectives. a) consistent with the Q-policy b) measurable c) take into account applicable req. d) relevant to conformity of prods & servs and customer satisfaction e) monitored f) communicated g) updated as appropriate maintain docu. info. on the Q-objectives. 6.2.2 (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) the org. shall determine: a) what will be done b) what resources will require c) who will be responsible d) when it will be completed e) how results will be evaluated Planning of changes change to the QMS shall be carried out planned . 6.3 consider: a) the purpose and potential consequences b) the integrity of the QMS c) the availability of resources d) the responsibilities and authorities 7 7.1 Support *Min. of 1 ex.: Resources 7.1.1 determine and provide the resources needed consider: a) capabilities and constraints on internal resources b) what needs to be obtained from external providers 7.1.2 People determine and provide the persons necessary for the implementation of its QMS and the operation and control of its processes. 7.1.3 7.1.4 Infrastructure & Environment for the operation of processes determine, provide and maintain the infrastructure/environment necessary for the operation of its processes 7.1.5 Monitoring and measuring resources determine and provide the resources to ensure valid and reliable results when monitoring or measuring.ensure that the *Evidence of conformity of products and services to specified requirements: crt_f_07.96e Revision 1

Valid from 01/01/2016

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ISO 9001:2015

Company: Client-no.: Order-no.:

Requirements resources: (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) a) are suitable for the specific type of monitoring and measurement b) are maintained to ensure their fitness *Evidence of fitness for purpose of monitoring retain docu. Info. of fitness for purpose of and measurement resources: monitoring and measurement resources. measuring equipment shall be: a) calibrated or verified, or both, at specified intervals, to measurement standards; when no standards exist, the basis for calibration shall be retained as docu. Info. b) identified to determine thestatus *Evidence of basis used for calibration c) safeguarded from adjustments, damage or verification (if applicable): or deterioration determine if the validity of previous measurement results has been adversely affected when measuring equipment is found unfit for its intended purpose, and take action . 7.1.6 Organizational knowledge determine knowledge for the operation of its processes and conformity of prods & servs. knowledge shall be maintained and made available. When addressing changing needs and trends, consider current knowledge and determine how to acquire additional knowledge and required updates. 7.2 Competence *Min. of 1 ex.: a) determine the competence of person(s) b) ensure that persons are competent c) actions to acquire the necessary competence, evaluate the effectiveness of the actions d) retain docu. Info. of competence Awareness ensure that persons are aware of: 7.3 a) Q-policy b) Q-objectives c) their contribution to the QMS, including the benefits of improved performance d) implications of not conforming with the QMS req. Communication 7.4 determine the communications relevant to the QMS: a) what b) when c) with whom d) how crt_f_07.96e Revision 1

Valid from 01/01/2016

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ISO 9001:2015

Company: Client-no.: Order-no.:

Requirements e) who (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) Documented information 7.5.1 The QM system shall include: 7.5 a) docu. info. required by this Int. Standard b) docu. info. determined by the org. 7.5.2 Creating and updating ensure appropriate: a) identification and description b) format and media c) review and approval for suitability and adequacy 7.5.3 Control of documented information 7.5.3.1 7.5.3.2 Docu. info. required by the QMS and Int. Standard shall be controlled : a) available and suitable for use, where and when needed b) adequately protected (e.g. loss of confidentiality, improper use, loss of integrity) address the following activities: a) distribution, access, retrieval and use b) storage and preservation, incl. preservation of legibility c) control of changes (e.g. version control) d) retention and disposition Docu. info. of external origin determined necessary shall be identified as appropriate, and be controlled. evidence of conformity shall be protected 8 8.1 Operation Operational planning and control *Evidence to show that processes have been carried out as planned: plan, implement and control the processes (4.4), for the provision of prods & servs and implement actions (6.1): a) determining req. for the prod & serv.s b) establishing criteria: 1) the processes 2) the acceptance of prods & servs c) determining the resources needed d) implementing control of the processes e) determining, maintaining and retaining docu. info. : 1) confidence that the processes have been carried out as planned crt_f_07.96e Revision 1

Valid from 01/01/2016

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ISO 9001:2015

Company: Client-no.: Order-no.:

Requirements 2) demonstrate the conformity of products and services. The output of this planning shall be suitable for the org.'s operations. control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. ensure that outsourced processes are controlled (8.4). (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) 8.2 Req. for products and services *Min. of 2 ex.: 8.2.1 Communication with customers shall include: a) providing info. relating to prods & servs b) handling enquiries, contracts or orders, incl. changes c) obtaining customer feedback relating to prods & servs, incl. customer complaints d) handling or controlling customer property e) establishing specific req. for contingency actions, 8.2.2 *Min. 1 complaint: Determining the req. for prods and servs ensure that: a) the req. are defined, including: 1) statutory and regulatory req. 2) those considered necessary by the org. b) the org. can meet the claims for the prods & servs 8.2.3 Review of req. for prods and servs ensure that it has the ability to meet the req. conduct a review before committing to supply prods & servs to a customer, to include: a) req. specified by the customer, incl. for delivery and post-delivery activities b) req. not stated by the customer, c) req. specified by the org. d) statutory and regulatory req. e) contract or order req. ensure that contract or order req. differing from those previously defined are resolved. customer’s req. shall be confirmed by the org. before acceptance, retain docu. info., : a) on the results of the review; b) on any new req. for the prods & servs 8.2.4 Changes to req. for prods & servs *Evidence describing the results of the review, incl. Any new or changed requirements:

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crt_f_07.96e Revision 1

Valid from 01/01/2016