Within the 3 year certification cycle, is surveillance audit frequency changeable?

jelly1921

Quite Involved in Discussions
#1
Within a three year certification cycle, can an organization change surveillance audit frequency?

In ISO17021:2011
9.1.9.7 Preparing audit conclusions
d) confirm the appropriateness of the audit programme or identify any modification required (e.g. scope,
audit time or dates, surveillance frequency, competence).

But in RULES for achieving IATF Recognition 3rd Edition for TS, I don't find such requirement, do I miss something or not?

Thanks!

Jelly
 
Last edited:
Elsmar Forum Sponsor
#2
Re: Within the 3 year certification cycle, is surveillance audit frequency changeable

Within a three year certification cycle, can an organization change surveillance audit frequency?

In ISO17021:2011
9.1.9.7 Preparing audit conclusions
d) confirm the appropriateness of the audit programme or identify any modification required (e.g. scope,
audit time or dates, surveillance frequency, competence).

But in RULES for achieving IATF Recognition 3rd Edition for TS, I don't find such requirement, do I miss something or not?

Thanks!

Jelly
Depending on which CB you've chosen and how many audit days your organization is required to have for surveillance, annually, you can have one or two visits. It's unlikely that 2 half day audits is going to be much use, but for 2 or more audit days, plus the incremental expenses, some organizations prefer 2 visits a year - keeps them 'on the ball' etc.

The CB auditor can also change it if they detect an problem with the system that indicates more frequent visits are necessary to assure the system is being improved, from a number of majors, for example.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
Re: Within the 3 year certification cycle, is surveillance audit frequency changeable

If you are speaking about TS the answer is no

Rules 5.1.1 Audit cycle
Surveillance audits shall be scheduled from the last day of the initial stage 2 audit or the last day of a recertification audit in accordance with table 5.1.
Once established, the surveillance interval as detailed in table 5.1 shall be maintained for the three (3)year audit cycle. In situations where the surveillance audit timing is likely to be exceeded, the certification body shall either initiate the decertification process (see section 8.0) or request a waiver from the relevant IATF Oversight office.
 
#4
Re: Within the 3 year certification cycle, is surveillance audit frequency changeable

Thanks for the clarification on the ISO/TS requirements, Howard! I'd overlooked that the OP might mean that.
 
Thread starter Similar threads Forum Replies Date
J Is Certification possible? A department within an organisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Supplier within the Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
W Major NCRs within AS9100 - What is the most frequent reason for Major NCRs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
O Monitoring performance - How do I determine performance measurement basis within my organization? Misc. Quality Assurance and Business Systems Related Topics 4
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Y Excel Automation - Printing Word Documents from within Excel Excel .xls Spreadsheet Templates and Tools 0
M Perform a coating weight test within 3 hours of processing the parts Manufacturing and Related Processes 2
C Validation of DocuSign within QMS Other US Medical Device Regulations 1
g_ehs Definition Protocol - for Assertions within Genetic Variant Databases Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
H Equivalence within Medical Device Family EU Medical Device Regulations 1
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Machine Relocation within Facility - Is re-validation required? ISO 13485:2016 - Medical Device Quality Management Systems 8
E AS9120B 8.4.2a Ensuring external providers remain within control of the QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
I Concerning procedures within Quality Manual ISO 17025 related Discussions 10
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
A CSR - How do you share them within your organization? IATF 16949 - Automotive Quality Systems Standard 3
G Outsourcing Processes within the Same Company (ISO 13485) Quality Manager and Management Related Issues 4
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Is it possible to receive EASA STC within 48 hours after modification? EASA and JAA Aviation Standards and Requirements 1
M Deficiency Taxonomy - Categorizing Deficiencies within my Organization Problem Solving, Root Cause Fault and Failure Analysis 4
S IEC 60601-2-27: What does "linear within ±20% of the full scale output" mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
T Training courses for improving 'Coaching and Mentoring skills' within Europe Training - Internal, External, Online and Distance Learning 1
V Site Master File for multiple business units within same premises/facility Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q Conflict Management - Systemic way to manage conflicts within Teams Book, Video, Blog and Web Site Reviews and Recommendations 6
M Creating change / Forcing change within a Company Lean in Manufacturing and Service Industries 7
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
K Estimation Sigma (Within) when subgroup n=1 (MiniTab) Capability, Accuracy and Stability - Processes, Machines, etc. 6
B Improving Safety Culture within an Organisation Occupational Health & Safety Management Standards 8
J Calculation of σ within subgroups for Cpk in Minitab Using Minitab Software 1
R Does oral irrigator fall within the scope of Medical Device Directive 93/42/EEC? EU Medical Device Regulations 11
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
C Sewage Discharge Consents - Proving within Limits ISO 14001:2015 Specific Discussions 7
O Changes to Component Parts within an Assembly AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Chennaiite Is Audit of Employee Canteen Food within the scope of OHSAS 18001? Occupational Health & Safety Management Standards 17
J PT/ILC - No Approved Programs within our Scope of Accreditation General Measurement Device and Calibration Topics 2
somashekar Customer Related Processes when a Customer is within the Corporation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Can the mandatory procedures of ISO 9001-2008 be documented within one procedure? Document Control Systems, Procedures, Forms and Templates 5
D Is embedding documents within a Contract an acceptable practice ? Contract Review Process 9
K What is Quality's and Engineering's role within FAI's AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? Quality Manager and Management Related Issues 6
W Quality Objective clarification - Requirements for "levels within the organization" Quality Manager and Management Related Issues 9
H % of Repaired Parts within a System Benchmarking 2
T Is IEC 61010 needed for a populated PCB within a unit? CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom